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1. total respiratory resistance R 6 3 2 Data evaluation e As described in section 2 3 2 the airway occlusion techniques for assessing passive respiratory mechanics are based on the ability to invoke the Hering Breuer Inflation Reflex HBR in infants and young children when lung volume is held above the end expiratory level e Provided rapid equilibration can be reached during brief periods of no flow the relaxation pressure at the airway opening represents alveolar pressure which in turn represents the summed elastic recoil pressure of the lung and chest wall during periods of muscle relaxation e The algorithms for calculating total compliance and resistance of the respiratory system are where Vext is the extrapolated expiratory portion of the flow volume loop to zero flow and P is the mean pressure at the airway opening during relaxation shown by a plateau against an end inspiratory occlusion Figure 104 ti tant Res ge kPa L s Gs R SO ue 0 38 kPa L s Cs where 0 38 is the resistance of the apparatus Rapp and T shown as the solid red line in Figure 104 is volume flow as calculated from the regression of the descending expiratory portion of the flow volume loop 142 Mouth pressurefkPa Mouth pressure 1 0 P1 05 200 400 600 9800 1000 1200 1400 1600 Figure 104 Passive mechanics data obtained using the single occlusion technique Legend Left pane shows a flow volume tra
2. 174 late jacket inflation ey ae ye eyo ep Figure 143 Effect of delayed jacket inflation during a RV manoeuvre passive expiration Legend Although the delay in jacket inflation was minimal 180 ms window A it nevertheless resulted in forced expiration occurring after 25 of the raised lung volume had been exhaled window B Figure 143 provides another example of FEFV curve resulting from a delay in jacket compression From the time based traces the volume plateau suggested relaxation and good timing with respect to lung inflation However there was a minimal delay of 180 ms in the onset of jacket inflation which resulted in a marked delay in forced expiration c Delay in releasing lung inflation Time based data in Figure 144 window A shows relaxed augmented breaths prior to RVRTC When RTC was triggered on the 4 inflated breath lung inflation was maintained a fraction too long i e poor synchrony between investigators such that forced expiration was delayed Consequently the FEFV curve was displaced to the right window B This trial is not technically valid 175 285 1 285 1 5136 5136 065 0 65 38 368 47 59 3 02 302 1635 163 5 Figure 144 An example of a technically unacceptable RVRTC curve Legend window A the observed plateaux for the inflated breaths and at airway opening suggest good relaxation of the respiratory system during passive inflation When jacket in
3. V 1 June 2014 Limitation of Liability Nothing in these conditions of use excludes or limits our liability for death or personal injury arising from our negligence or our fraud or fraudulent misrepresentation or any other liability that cannot be excluded or limited by English law To the extent permitted by law we exclude all conditions warranties representations or other terms which may apply to the manual or any content in it whether express or implied We will not be liable to any user of the manual for any loss or damage whether in contract tort including negligence breach of statutory duty or otherwise even if foreseeable arising under or in connection with e use of or inability to use the manual or e use of or reliance on any content displayed on the manual Please note that we only provide the manual for domestic and private use You agree not to use the manual for any commercial or business purposes and we have no liability to you for any loss of profit loss of business business interruption or loss of business opportunity We will not be liable for any loss or damage caused by a virus distributed denial of service attack or other technologically harmful material that may infect your computer equipment computer programs data or other proprietary material due to your use of the manual or to your downloading of any content on it or on any website linked to it Acknowledgements Production of this m
4. When selecting reference data with which to interpret clinical lung function results from an infant or young child it is essential to check how appropriate these data are with respect to whether e the same equipment technique quality control and methods of analysis were used e equations were derived from a comparable and sufficiently large population with even distribution of age and body size The need for sedation and the duration of studies limit the number of healthy infants who can be studied at any one centre While international collaborative efforts led to the publication of sex specific reference data for V maxrrc during infancy that proved appropriate at the time for custom built equipment Hoo et al 2000 section 7 5 the development of commercially available devices for infants appears to have introduced some bias necessitating the development of equipment specific equations for infant LFTs before clinical studies in individual infants can be interpreted properly During recent years it has been shown that when using the CareFusion equipment previously published reference values for plethysmographic lung volumes Hulskamp et al 2003 section 7 5 and both the tidal or raised volume RTC technique Lum et a 2010 section 7 5 are inappropriate and can lead to serious errors in interpretation Equipment specific reference 180 equations for tidal breathing outcomes passive respiratory mechanics and plethysmographic FRC
5. n u dates patient ID or leaving cells blank the Merge procedure may be carried out 218 Since the Destination is a newly created folder i e not an existing database to merge out data to the Destination folder hence creating a Destination data base the user needs to click on Create database to complete the task been extracted routine allowing data to be stored securely gt Database utility Merge 5 05b 1 make sure Source data base is correctly selected this is where all your lung function data are stored 4 If you intend to export or merge out data collected over a period of time then use this function i e enter dates e g 01 01 2014 to 31 01 2014 then all data recorded between these dates will get exported or merged out Figure E This summarises the data merge out process E UAEGER Z Scores Templates Sep20t0 Select Create database Opora F Do not mage calbestion patients krcis user bets I inchado PatieniManager date Conade date wm a sre pert beritan pzas A computer screen display will provide information such as the number of datasets have Check the Destination data base and a series of files merge log xx DAT xx IDX xx LCK should be visible These extracted data may be merged in to another Lab4 DB The Merge out procedure may be performed regularly e g weekly as a back up 2 make sur
6. respiratory rate RR tidal volume V7 time to peak tidal expiratory flow as a percentage of total expiratory time tpre te Figure 100 left panel Flow ml s 150 Flow ml s le i l i j a PTEF Volume mI i 80 100 120 I Expiration Figure 100 Graphic displays of tidal breaths Legend Left This window shows flow versus time for 21 tidal breaths grey curves with the mean flow time data shown in black Right This panel displays the same 21 breaths as flow volume loops with the mean indicated in black 6 2 2 Data evaluation e The Tidal Breathing software identifies tprer t and the expiratory volume up to tidal peak flow Voce as a percentage of total expiratory volume Vex as the 2 key parameters Since the shapes of tidal flow volume loops hence tprer te and Vper Vex Show large variability in order to avoid the possibility of bias one outlier could introduce to the average values the software program uses the following procedure to eliminate outliers during data collection continuous analysis is being performed using the last 20 breaths according to size the upper and lower 25 of values are eliminated and only the mid 50 of value are considered valid NOTE see section 3 4 2 for more details regarding CareFusion s default settings for online tidal breathing analysis and modifications that individual LF laboratory may adapt with res
7. as depicted by the downward and upward swings of the P trace with at least 2 peaks after the initial pressure plateau during occlusion from which FRC values are reproducible within 5 6 4 3 Data evaluation In order to assess plethysmographic FRC accurately the relationship between AV and AP measured during airway occlusion must be in phase when plotted graphically Figure 118 window D If these signals are not in phase there may be poor equilibration between the change in alveolar pressure AP and AP presence of glottis activity a leak around the face mask or less commonly a leak in the plethysmograph 152 Dum davon tek tedcanore nore L Menu bar ox 30 Window C result table B FRO 163 Ont m FRCP 1 159 0mt FRCp 2159 Sent FRCp 160 7mL delta Pao vs delta VB Ne Figure 118 Infant plethysmographic FRC measurement see text for details Figure 118 shows a technically acceptable FRC measurement from a 10 month old infant section 6 4 2 Over the duration of the airway occlusion 7 s the flow and volume signals were constant window A following the release of the airway occlusion the EEL returned to the pre occlusion baseline suggesting a good mask seal i e no leak window B It is common for infants to make a larger sigh like inspiratory effort immediately after the balloon shutter is released as seen in this example Window D displays good phasing closed loops betw
8. ccctccesecsecedeeeciiiesaeet capes dlevivaeeds AA AEE E 91 3 4116 Order of tests ai eee e a er te E a a a pep a A a a 94 4 Infant preparation scssisiriescriirossnsr irinn sranna Er EAN EA a a AA 95 4 1 Infant factors e a adh atin E e 95 Alr Health statuse a a a sana de a ee A A A a aa N enia 95 41 2 AGC rahe e a a a a n aa oa avian 95 4 2 Organising lung function appointments cccceseessssecececeeesseseeaeeeeeceseesesteaeeeeeeeeseeeas 95 4 2 1 Parental information isien oaeaeei iaaiaee 95 4 3 Preparing for lung function COSTS ccccccccsesssssececeescsesesseaeeececeseesesaeaeceeeceseessaasaeeeesens 96 V 1 June 2014 4 3 1 On the day before the tests cccccccssssssceceeeeeceessnseseeeceeeeeesesssaeeeeeesesssesseaeas 96 4 3 2 On arrival tothe Lung Function Lab iccccc cece disecedsacsencaccrsctedeasseseecnesuetinceends 96 4 3 2 1 CONSENt Ascii eave aed arated heen eae aa 96 4 3 2 2 Clinical examinations cedecice scees cesteeehseceve ENEA Tassebedacg a E a a feadetedade es 97 4 3 2 3 Anthropometric measurements cccccccccssssssssececececsssesneaecececesseseasaeeeeecessessnseseeeesens 97 A 3 2 3 1 BOdY Weight n Ach acl Aer th ed i Aa A eee i aes 97 4 3 2 3 2 Crown heel length cic ciiur a a abe a N a a ia 97 A 3 253 3 Head circumferences asr biisinna iernii n cdacdestvecncandiedeescitve saccestadedaahteanecbiiedeescitessecet eazes 98 4 3 3 Records and documentation ccssccccssssececsessecececse
9. A delay in achieving PEF i e Vper Vr gt 30 V Figure 134 may lead to a distorted calculation of V maxerc Thus the trial should be invalidated Figure 134 An example of delayed attainment of PEF due to a late rise time Legend The original partial FEFV curve is shown in blue left lower window with PEF being achieved gt 30 of tidal volume of the breath prior to the squeeze manoeuvre The superimposed FEFV curve with a rapid jacket rise time in brown illustrated that V maxrrc for the blue FEFV curve is likely to be overestimated due to the late rise time 167 6 5 5 Transmission of jacket pressure Pj As mentioned previously it is important to include P transmission Paj as a quality control assessment and this should be at least 2 kPa in healthy infants section 5 5 3 in whom every effort is required to achieve flow limitation to avoid underestimating maximal forced expiratory flows By contrast flow dependence may be achieved at lower P in infants with airway disease or obstruction Figure 10 section 5 5 3 In contrast to the example shown in Figure 88 which illustrates a technically acceptable Pj transmission manoeuvre Figure 135 demonstrates a similar assessment that failed to meet quality control criteria due to a mask leak following the inflation of RTC jacket during an airway occlusion The presence of the Pao plateau P1 suggests that the mask seal was satisfactory when the occlusion was made initia
10. Figure 76 Program option for saving tidal breathing measurement During the first 2 years of life mean tprer te ratio of 26 7 range 12 64 has been reported Nguyen et al 2013 section 7 5 Figure 77 illustrates data recorded from an infant in whom flow limitation was evident during tidal breathing mean tprer te 12 marked concavity of the expiratory flow time curve was noticeable Figure 77 An example of data from an infant in whom flow limitation is evident during tidal breathing 112 V 1 June 2014 5 3 Passive respiratory mechanics total respiratory compliance Crs and resistance Rrs In this manual only the single occlusion SO technique will be described this program allows simultaneous calculation of C Rrs and the expiratory time constant The process of setting or reviewing the sample frequency and contents of result table has been described in sections 3 4 4 1 and 3 4 6 Check that all program settings are correct section 3 4 5 A list of Function keys are available in the Appendix section 8 3 5 3 1 To start data collection for passive respiratory mechanics Click on F1 Start of tidal breathing registration Once a stable EEL is achieved following a recording of 5 8 regular breaths the F3 key Start measurement with next breath will be illuminated Click on F3 to activate inflation of the shutter balloon to perform a brief airway occlusion at end inspiration Data coll
11. Koopman M Verheij TJ van der Ent CK Reduced neonatal lung function and wheezing illnesses during the first 5 years of life Eur Respir J 2013 42 1 107 15 van Putte Katier N van der Gugten AC Uiterwaal CS de Jong BM Numans ME Kimpen JL Verheij TJ van der Ent CK WHISTLER study group Early life lung function and respiratory outcome in the first year of life Eur Respir J 2012 40 1 198 205 Bisgaard H Jensen SM Bonnelykke K Interaction between asthma and lung function growth in early life Am J Respir Crit Care Med 2012 185 11 1183 9 van Putte Katier N Koopmans M Uiterwaal CS de Jong BM Kimpen JL Verheij TJ Numans ME van der Ent CK WHISTLER study group Relationship between parental lung function and their children s lung function early in life Eur Respir J 2011 38 3 664 71 191 e Latzin P Roosli M Huss A Kuehni CE Frey U Air pollution during pregnancy and lung function in newborns a birth cohort study Eur Respir J 2009 33 3 594 603 e Devulapalli CS Carlsen KC Haland G et al Severity of obstructive airways disease by age 2 years predicts asthma at 10 years of age Thorax 2008 63 8 13 192 8 Appendices 8 1 List of manufacturers Masterscreen BabyBody Plethysmograph CareFusion UK Global http www carefusion com medical products respiratory cardio pulmonary diaqnostics pulmonary function testing LFT complete testing masterscreen babybody and pediatric aspx Face masks Rendell Baker
12. Lung Function Laboratory Level 1 Great Ormond Street MUO Morgan Stanley Clinical Building Hospital for Children Telephone 020 7405 9200 ext 0404 a atc a Great Ormond Street London WCIN 3JH INFANT LUNG FUNCTION REPORT GOSH Consultant GOSH No NAME SEX DOB Study No Gestational age Dr CW 12345 BW female 08 01 2012 53239 41wt id Measurements Test 1 Test 2 Test 3 Expected range 21 05 2012 23 01 2013 12 11 2013 Age corrected for GA 2o 3weeks __ ttyears __ adyears Length 1 0 z 61 2 cm 1 5 z 71 0 cm 2 2 z 78 0 cm 2 z score Lung function parameters Lung clearance index LCI 2 2 z 8 7 0 9 z 7 4 2 z score FRCwew z score 1 5 z 16 mL kg 2 z score FRCpieth z score 0 7 z 18 mL kg 2 z score 0 7 z 216 mL 2 z score 1 4 0 7 z 462 mL s 0 8 z 412 mL s 0 4 z 596 mL s 2 z score Results expressed as z or SD score with absolute values in parentheses Abbreviations LCI lung clearance index FRC functional residual capacity MBW multiple breath insert gas washout method pleth whole body plethysmography FEVo s forced expired volume at 0 5s FVC forced vital capacity FEF2s 75 forced expired flow between 25 75 of expired FVC References Lum et al 2013 Nguyen et al 2013 Lum et al 2010 5 4 9 g 9 6 y N z FRCpieth 60 60 Postnatal age w Postnatal age w 60 Postnatal Age w Dashed lines represent
13. New start of complete measurement New start of complete New start of complete New start of complete measurement measurement measurement measurement F10 Save data and exit program Save data and exit program Save data and exit program Save data and exit program Save data and exit program a default setting maximum P of 5 kPa b click on Advance button to edit P up to a maximum of 17 kPa 195 8 4 An example of parental information leaflet The test was one of the first developed and has been in use all around the world for more than 20 years It gives us similar information to that gained from lung function tests done in adults Nasal brushing is a safe procedure It has been described that mild nose bleeding can seldom occur Skin prick test is a safe procedure Discomfort due to itchiness can occur which usually disappears within 30 minutes and can be alleviated with cold compresses if necessary What choice do you have Participation in any test is entirely voluntary If you decide that you do not want your child to participate it will not affect the health care you or your child receive Ifat a later date you wish to withdraw your child from the study you are free to do so at any time All information is kept strictly confidential and your child s name will not appear in any reports The results of studies will be collated and communicated to the scientific community They may also be
14. R AP AV Hence to assess respiratory mechanics it is necessary to record changes in pressure and flow with volume usually obtained by integrating flow V Flow x time While flow and volume are usually measured using some type of flow sensor PNT at the airway opening pressure 31 V 1 June 2014 changes can be measured in a variety of ways which will determine exactly which outcome is measured For example if the resistance of the airways is to be measured in isolation then a measure of pressure changes between the alveoli and airway opening obtained during plethysmography is required By contrast when the occlusion technique is used to measure total respiratory compliance the sum of pressure changes across the chest wall lungs and airways are measured such that the resistance and compliance of the total respiratory system are assessed Since compliance increases as the lungs grow whereas resistance decreases results are sometimes standardised for lung size by expressing them as specific compliance sC C FRC or specific resistance sR R x FRC 2 3 2 Passive Respiratory Mechanics Measurements of passive respiratory mechanics compliance resistance and Ty are potentially possible if a state of relaxation can be induced in the respiratory system In contrast to older subjects in whom this is very difficult to achieve without extensive training the vagally mediated HBR is active within the tidal volume rang
15. You may use the manual solely for your own personal non commercial use and you may not use the information contained in the manual except as provided for in these conditions of use The manual is not for commercial exploitation You may not decompile dissemble or create derivative works from the manual If you do not agree to these conditions of use you must not use the manual Disclaimer The accuracy completeness adequacy or currency of the manual is not warranted or guaranteed We do not guarantee that the manual is free from errors or omissions Your use of the manual is at your own risk The data in the manual are not intended as and does not constitute advice of any nature The manual is not intended to be and must not be relied upon in the performance and interpretation of infant lung function testing This manual is not intended as and must not be used or relied upon as a user manual for CareFusion MasterScreen BabyBody Plethysmograph or any other similar devices Summary of Manual e The details included in this manual are based on assessments of infant lung function using the CareFusion MasterScreen BabyBody Plethysmograph with RVRTC v 4 67 as currently performed in two well established laboratories in the UK and Australia e Such practices may need to be modified in other institutions e Hospital institute ethics safety and hygiene regulations must always be adhered to and assessments only carried out by suitab
16. of baseline breaths pre squeeze E E be Pre 1queeze occlusion time oo g Cancel Minimum of baseline breaths post squeeze 5 E be Data analysis Number of baseline breaths analysed 5 E o Vahdation Pi threshold relative to Pr Pi stability Volume expired at PEF relative to VT Jacket control Max compres ton time Inspaatory flow threshold Figure 32 The Measurement menu displays the recommended criteria Legend The maximum compression time indicated by the red circle may be edited by the user according to the individual infant s background history 3 4 8 3 Setting quality control criteria for tidal RTC manoeuvres e The criteria shown in the Validation Measurement panel Figure 32 are related to quality control 66 V 1 June 2014 Pj threshold relative to Pr the difference between Pj and Pr should not exceed 50 as that would indicate a leak occurring along the conduit from the reservoir to the jacket bladder Pj stability the mean Pj measured during jacket inflation should be relatively consistent gt 80 consistency can be expected in the absence of a leak between the large bore tubing and jacket bladder Volume expired at PEF relative to Vz Vpe V1 jacket inflation at end inspiration should rapidly force expiration such that peak expiratory flow PEF is achieved before 30 of V has been exhaled The analysis of V maxrrc May be distorted if Vpep Vy is gt 3
17. time of test Menu bar BabyBody 4 67a Dummy Dummy 10001 60 04 09 2013 16 39PM Monitor 1 200 gt Flows e s Jp window f 5 0 15 a 3 Ki aS ae i Result window Online graphic windows time elapsed since starting program VIASYS Healthcare GmbH 1992 2004 storage space filled Status line Figure 19 The standard layout of the CareFusion system screen display acting as a measure of safety and quality control the Monitor window monitors the infant s breathing pattern hence his her well being As soon as the mask and PNT are placed over the infant s airway opening click on F1 immediately to start the monitoring process the recording is not stored the Menu bar allows access to the command menus where default settings may be selected or edited the Icon bar comprises icons which are used to activate sequences and function of the measurement program The user operates or activates a certain aspect of the program by clicking on a specific function icon numbered from 1 to 10 Alternatively the corresponding Function keys F1 to F10 on the computer keyboard may be used instead e g clicking on the F2 icon on the monitor screen is the same as pressing on the function key F2 on the keyboard and so on the Status bar displays information such as a current phase of program at time of use b duration of time spent within a test program e g how long the plethysmograph has
18. 1 1 Raised Volume RTC equipment set up e The Raised Volume RV manoeuvres are performed following completion of the tidal RTC test and the equipment set up is shown in Figure 17 Figure 89 and section 2 6 3 e The optimal reservoir pressure determined for each individual infant during the preceding tidal RTC manoeuvres at which the best V naxrac Were determined will be used for the RV manoeuvres e It is important therefore not to disturb or alter the jacket fitting prior to performing the RV manoeuvres otherwise P will need to be re assessed using the Tidal RTC program with the newly fitted jacket in situ 125 Pressure relief valve insp exp Pressure Fresh gas flow T piece relief valve connector Large bore tubing Reservoir tank Figure 89 Schematic diagram showing the apparatus set up for performing the Raised Volume manoeuvres 5 6 1 2 To start raised volume RTC data recording e Maintain continuous monitoring of the infant s vital signs e Select Raised Volume Squeeze in the LabMan main program page Figure 18 e Click on F6 Change reservoir pressure to set the optimal reservoir pressure P as determined during the preceding tidal RTC manoeuvres If the required P is gt 5 kPa click on the Advance button to allow appropriate P setting e Gently and carefully remove the balloon shutter from the PNT mask unit which is already applied to the infant e Turn on the medical air supply at a f
19. 3 1 1 3 3 1 2 3 3 1 3 3 4 3 4 1 3 4 2 3 4 3 3 4 3 1 3 4 3 2 3 4 3 3 3 4 4 3 4 4 1 3 4 5 3 4 6 3 4 7 3 4 7 1 3 4 7 2 3 4 7 3 3 4 8 3 4 8 1 V 1 June 2014 Equipment and apparatus cesessessscecececessesensececeeecesseeaaeeececsseeseasaeceeeeeseeseaeaeeeeeens 47 Masterscreen BabyBody Plethysmograph CareFUSION ccccccsssceceesseeees 47 Resuscitation trolley and suction apparatus cseeecesesececeeseneeeeeesseeeesssteeees 48 Basic accessories for lung FUNCTION tests cccccsscececeesssesseececeeeessessesteseeeeees 48 Face MASKS Areora EAE AEA N EE AEE DA E ATE NE E AAA 48 Therapeutic PUtty cao ineine eainiie a esa aaa asa Bia a rehi aat 49 BaloomS NURE erre E TETT EE T NOOT NOE NEN 49 Additional accessories when undertaking forced expiratory manoeuvres 49 RIG jacket and bladder mnia EE E ERT AEA 49 Specific accessories for the Raised Volume Squeeze sssesesessessssssesrrreses 50 Neopuff Infant T piece Resuscitator Fisher Paykel Healthcare cc ccccceeseees 50 Preparation for testing cccccccssssssscececscsssssensececeesesesusassececeesesesseaesececessesssananseceesess 52 Laboratory set UP ANd EQUIPMENT cecccessessssececececsesessaeeeceeeenseeseaeaeeeeees 52 Equipment SPECIFICATIONS sieisen ei aare aai aa i es aeri aena eiei 52 The Masterscreen BabyBody Plethysmograph cssccccccsssssssssseeeeecesesssstsaeeeeeens 52 LabManager Interface i ern
20. Bisgaard H Loland L Holst KK et al Prenatal determinants of neonatal lung function in high risk newborns J Allergy Clin Immunol 2009 123 651 657 657 e Yemen S Gaston B Lung function test results in normal infants a COPSAC sequel J Allergy Clin Immunol 2009 123 658 659 7 9 3 Preterm delivery e Friedrich L Stein RT Pitrez PM et al Reduced lung function in healthy preterm infants in the first months of life Am J Respir Crit Care Med 2006 173 4 442 447 e Friedrich L Pitrez PM Stein RT et a Growth rate of lung function in healthy preterm infants Am J Respir Crit Care Med 2007 176 1269 1273 e Sanchez Solis M Garcia Marcos L Bosch Gimenez V et a Lung function among infants born preterm with or without bronchopulmonary dysplasia Pediatr Pulmonol 2012 47 7 674 681 190 McEvoy C Venigalla S Schilling D et a Respiratory function in healthy late preterm infants delivered at 33 36 weeks of gestation J Pediatr 2013 162 3 464 469 Latzin P Roth S Thamrin C et al Lung volume breathing pattern and ventilation inhomogeneity in preterm and term infants PLoS One Electronic Resource 2009 4 2 e4635 Schmalisch G Wilitzki S Roehr CC et al Development of lung function in very low birth weight infants with or without bronchopulmonary dysplasia longitudinal assessment during the first 15 months of corrected age BMC Pediatrics 2011 12 37 Filbrun AG Popova AP Linn MJ et al Longitudinal measures o
21. Compared to the example in Figure 132 this partial FEFV curve was mild to moderately interrupted by glottic narrowing during early phase of expiration Notice the fluctuations on the expiratory flow signal which may reflect presence of airway secretions mobilised during the manoeuvres Figure 133 shows a PEFV curve that was mild to moderately interrupted by glottic narrowing during early phase of expiration The interruption to forced flow occurred shortly after the 166 start of forced expiration and appeared to resume normal flow half way through expiration such that the remaining flow volume curve overlaid with two other curves Act 1 blue P 7 kPa and Act 3 green P 8 kPa see trend window and result table that were technically acceptable V maxerc derived from Act 2 133 mL s is well within 10 or 10 mL s of values from either Act 1 or Act 3 In this example because 2 other technically satisfactory and reproducible curves with a mean V maxerc Of 128 5 mL s are available in addition to Act 2 it would be feasible to include Act 2 in the final calculation of mean V maxrac Note it can be seen from the trend window that besides the 3 Acts that were selected shown in colours a further 3 manoeuvres with increasing P were undertaken but without further increase in forced flow Late rise time Provided that the jacket is inflated rapidly at end inspiration PEF is generally achieved before 30 of Vz has been exhaled
22. FRC measurement possible Figure 81 The screen shows a stable box volume signal and regular tidal breathing prior to the onset of an airway occlusion for FRC measurements Legend The real time window A indicate that 3 respiratory efforts were recorded during the airway occlusion of 7 seconds window D demonstrates perfect phase relationship no looping between changes in box volume and airway opening pressure during airway occlusion Note Due to limited software memory higher sampling frequency required in infants compared to adults due to the high breathing frequency and software for the Babybody device yet to be upgraded to 64 bit it is not always possible to record more than 2 trials per test especially when testing older infants Since 3 5 valid trials are required for reporting section 6 4 5 at times it is necessary to save the recorded FRC data after every 2 trials by 117 V 1 June 2014 clicking on F9 and continue to data collect until sufficient measurements have been acquired also see section 5 4 4 If there was evidence of mask leak or PNT leak at any time stop data collection so that the problem may be rectified open the box re adjust or remove and re position the mask to create a good mask seal Click on F8 to re set zero baseline for flow volume signal perform atest occlusion after a stable EEL has been established to the mask seal lower the hood to close the plethysmograph wh
23. FRC results are unreliable 156 b Glottic activity Best Act Act Act3 Act4 Co 5 imi 1m FRCp 0 62 2mL m FRCp I 70 6mL 2 m FRCp 2 72 6mL Figure 122 FRC data with evidence of glottic activity and possible mask leak Figure 122 illustrates FRC data Act 1 blue trial button in a 3 month old infant regular breaths with a stable EEL at the start of data were recorded window A The airway occlusion ended i e shutter balloon deflated after 3 respiratory cycles had been detected this was followed by a sigh breath and 10 tidal breaths before tidal volume and EEL apparently returned to pre occlusion status However on review window B d EEL were gt 20 window C suggesting a mask leak which may have been caused by the resultant effort of the sigh breath The phase relationship or the slope for the regression lines AP versus AV for the 3 respiratory efforts against the closed shutter were not similar window D Figure 122 compare with window D Figure 120 As can been seen in Figure 122 window D with the exception of a good phase relationship for FRC 0 blue loop both FRC 1 red and FRC 2 green showed opened loops red circle Figure 122 window D which are likely to be due to glottic activity Values calculated for FRC 1 and FRC 2 separately were 8 smaller than that calculated for FRC 0 Unless additional trials with similar results had been recorded to support FRC value from this tria
24. V4 67a Dummy Dummy 10001 New test Best Actl Act2 Act3 Act4 Act5 Settings Measurement Data collection 504 vo Minimum of baseline breaths pre squeeze E g b Pre squeeze occlusion time 0 0 s Minimum of baseline breaths post squeeze 6 3 br Data analysis Number of baseline breaths analysed 5 br Validation Pj threshold relative to Pr COE Pj stability fox Volume expired at PEF relative to VT 30 az Jacket control Max compression time 3 0 s Inspiratory flow threshold ol Figure 39 Measurement criteria settings for the Raised Volume RTC Legend These criteria are similar to those set for tidal RTC manoeuvres with the exception for Max compression time which is set to 3 seconds highlighted by the red circle 72 V 1 June 2014 3 4 9 3 Setting the jacket trigger for Raised Volume RTC e In contrast to the tidal RTC the Manual mode is preferred for the raised volume manoeuvres Figure 40 e Technically acceptable full forced expiratory flow volume curves require perfect co ordination between the two operators operator A executes and completes 3 5 passive lung inflations when instructed by operator A operator B manually triggers jacket inflation by clicking on F3 icon or firmly pressing down and releasing the space bar rapidly just as the inspiratory flow volume curve of the final inflated breath is about to cross zero flow allowing a few nano seconds for jacket
25. balloon shutter Repeat the test procedure Shutter balloon test x Incorrect shutter balloon test Type 2 E Figure 67 An error message indicating Note that a fault has been The balloon was leaking during the shutter balloon test detected during the Patih toascne shutter balloon test Leaky shutter balloon possibly due to a Pressure pump defective x leaking balloon or It is impossible to perform a measurement with a defective poor fit of the tube shutter connection between Error type 2 Shutter balloon leaky or not connected the shutter and control panel T 15 ms T 30 ms T 45 ms P1 614 mBar P2 594 mBar P3 e Once the plethysmograph has been calibrated and balloon shutter checked the Masterscreen system is ready for the assessment of FRCpictn in addition to the other tests 93 V 1 June 2014 3 4 11 6 Order of tests e Recordings of tidal breathing passive respiratory mechanics data and or plethysmographic FRC should always be performed prior to forced expiratory manoeuvres to avoid the potential effect of jacket placement and repeated chest compressions e Tidal squeeze manoeuvres should be performed before the raised volume manoeuvres for the following practical reasons the identification of optimal jacket pressure at which flow limitation is evident for individual infants which is to be used during the raised volume manoeuvres is achieved during the tida
26. been closed while collecting FRC data and c of data storage space already filled this is informative to the user in terms of planning the sequence of data collection e g save the data already recorded before starting a new sub set of data collection 54 V 1 June 2014 the online graphic windows display data in different graphical formats which are dependent upon the programs used at time of data acquisition e g Figure 70 Figure 75 the result window shows lung function parameters and selected quality control criteria set by the users 3 4 Preparation prior to performing equipment calibration 3 4 1 Displaying quality control criteria During data recording in addition to the online display of calculated values for the main outcomes for each test several other outputs relating to quality control should also be displayed these allow comparison of data collected within and between centres e g total number of manoeuvres of which number of successful trials per test or transmission of jacket pressure In addition quality control settings for each individual trial facilitate selection of the best data Many of these quality control features are required when summarising data for publications therefore such data should be saved and stored in a database or data sheets 3 4 2 Setting up essential criteria for test programs Prior to equipment calibration and data collection it is essential to undertak
27. bladder to fill and aiming to effect chest compression to force flow at end inspiration i e when operator A releases the manual occlusion over the end of the Neopuff T piece to end lung inflation RVRTC V4 67a Dummy Dummy 10001 New test 0 200 Settings Trigger x Manual instantaneous Flow mls 2 Figure 40 The Manual mode for triggering jacket inflation is preferred for the Raised Volume RTC manoeuvre 3 4 9 4 Setting safety criteria for Raised Volume RTC Similar safety default settings for tidal RTC section 3 4 8 6 are applicable for the Raised Volume RTC manoeuvres Figure 36 and Figure 41 73 V 1 June 2014 RVRTC V4 67a Dummy Dummy 10001 New test 104 Volume kg ml kg 0 10 Warning No flow signal 0 Volume ml PAA Uy xl Minute ventilation Warning threshold 100 Eml min kg No signal warning delay 5 g Cancel Jacket pressure warning threshold 0 2 EjkPa Occlusion warning threshold 02 kPa Default Flow ml s 200 Figure 41 Default settings for safety criteria for the Raised Volume RTC technique 3 4 9 5 Contents of Raised Volume RTC result table To review and or edit the list of variables displayed in the results table e Goto the menu bar click on Program gt Modify settings e Return to the menu bar click on Settings gt modify gt Parameter list gt Contents of Table e Browse through the list of parameters and s
28. but also of respiratory mechanics and forced expiratory flows FEF all of which are highly volume dependent Developmental changes in respiratory rate and mechanics may also have significant effects on the interpretation of longitudinal changes for various indices such as timed forced expired volumes FEV 23 V 1 June 2014 1 2 2 Dynamic elevation of end expiratory level The highly compliant floppy chest wall in young infants results in minimal outward elastic recoil such that the lungs tend to recoil to a much lower volume in relation to total lung capacity TLC than in older subjects The subsequent instability of functional residual capacity FRC and tendency for small airway closure during tidal breathing due to the low transpulmonary pressure at end expiration during the first 6 12 months of life are partially compensated for by dynamic elevation of the end expiratory level EEL i e the tendency for the infant to take the next breath in before elastic equilibrium volume EEV is reached This may be achieved by vagally mediated upper airway narrowing or diaphragmatic modulation of expiratory flow to slow brake lung emptying and or a rapid respiratory rate short expiratory time Figure 1 A fall in EEL may be observed during brief apnoeic periods Young infants also sigh periodically when inspiration is 2 3 times greater than observed during regular tidal breathing This may alter ventilation distribution and interf
29. data sets are stored and available for later reanalysis Key parameters are displayed on line as a trend allowing visualisation of the stability of breathing patterns and or attainment of reproducible results during data collection Measurements in term and spontaneously breathing preterm neonates e g from 2 kg are feasible Software has been cross validated against existing previously validated programs 227 Equipment and software can be tested in vitro with the use of a dummy or mechanical lung The equipment is CE marked and FDA approved The software continuously monitors respiratory effort providing PNT face mask are connected to the infant and software program has been activated It also provides a warning message if respiratory effort is absent 4 Limitations Data summary within the program currently reflects routine adult clinical applications rather than the requirements of neonatal paediatric research Automated generation of reports need further work Appropriate reference equations need to be adopted and uploaded Software currently in 32 bit thus limiting the duration of data recordings and there are inconsistencies between different programs Specific airway resistance SRef not validated appears to discriminate poorly between health and disease improved algorithm needed 228
30. for custom built equipment the development of commercially available devices for infants appears to have introduced some bias necessitating the development of equipment specific equations for infant LFTs before clinical studies in individual infants can be interpreted properly Lum et a 2010 Nguyen et al 2013 section 7 5 2 8 Bronchodilator Responsiveness An observed change in baseline airway tone upon inhalation of a bronchodilator e g Albuterol also known as Salbutamol is referred to as bronchodilator responsiveness BDR The limits of normal range of BDR defined as 1 96 Z scores from the mean have been described in healthy infants using the RVRTC technique Goldstein et a 2001 section 7 8 Based on these data an abnormal i e positive BDR was defined as a percentage increase in FEV of greater than 13 or in FEV gt s 7 of greater than 24 There is a decline in BDR with age and an increase in tobacco smoke exposed healthy infants Goldstein et a 2001 section 7 8 In infants with recurrent wheeze an increase in BDR was associated with shorter body length for age Debley et al 2012 section 7 8 but no association was observed with established asthma risk factors 45 V 1 June 2014 Normally in infants bronchodilator agents are therapeutically inhaled during tidal breathing via a spacer However the RVRTC associated BDR protocol utilises an inflation pressure 25cmH O to deliver the Albuterol Salbutamol via a s
31. has yet to be established However several studies have indicated that RVRTC may be more discriminative than tidal RTC for distinguishing the effects of respiratory disease on airway function Although there is insufficient evidence to produce firm guidelines an ATS ERS Task Force has produced a consensus statement that provides preliminary recommendations pertaining to equipment study procedures and reporting of data for the RVRTC based on what is perceived to be current best practice section 7 4 4 2 6 3 1 Analysis and Reporting of RVRTC Results The values that are most commonly reported from the RVRTC include e FVC forced vital capacity from the applied inflation pressure e g FVC39 e FEVo s 0 5 0 75 forced expired volume at 0 4 0 5 or 0 75 seconds 42 V 1 June 2014 e FEF7sy forced expiratory flow at 75 of expired FVC e FEF 54 75 forced expiratory flow between 25 and 75 of expired FVC It should be noted that despite common use of the term FVC for the total volume expired during the raised volume technique this does not necessarily equate to measures in older subjects because infants have been observed to take a sigh at the end of an inflation to 30 cmH 0O demonstrating that TLC has not actually been attained Calculations of FEV and to a lesser extent FEV 7 5 are rarely feasible in young infants except in the presence of marked airway obstruction due to the rapid lung emptying and short forced expiratory
32. have recently been published Nguyen et a 2013 section 7 5 as has a correction factor for forced expiratory flows and volumes Lum et a 2010 section 7 5 Users of the CareFusion Masterscreen BabyBody device are strongly recommended to use these equations see Table 5 However it should be noted that these equations have been derived from White infants of European descent and may not be applicable to infants of other ethnic origin An example of a report comprising serial measurements in a young child with CF is included in the Appendix section 8 9 Lung function results have been expressed as Z scores according to the recommended reference ranges that are included in Table 5 and Tables 6 A and B Table 5 Equipment specific prediction equations Nguyen et al 2013 Predicted value RSD RR min 2 588 1876 034 L 38 906 A 0 718 267 256 L 2 222 A Va mL 38 347 1 128 x L 0 204 x A 3 688 x 2 403 0 015 x L 0 118 x A 0 136 W x W Ln tprer te 3 231 0 320 Crs mL kPa 84 904 2 470 x L 0 429 x A 3 975 0 170 x L 0 143 x A Ln Rs kPa L s 0 094 84 877 L 0 203 2 966 L FRCpieth ML 130 225 3 711 x L 0 515 x A 0 187 x AxM 12 657 0 526 x L Abbreviations L length in cm A age in weeks W weight in kg M male male 1 and female 0 RSD residual standard deviation Ln natural log RR respiratory rate V tidal volume tprer te tim
33. in inhibition of inspiration and prolongation of expiratory time 33 Schematic diagram of equipment used for passive mechanics using the occlusion LECAHIGUEHM MM AMTANUS 225 5 EAEE Aces ade RAE eats Sates ede hehe eee oe 34 Assessment of passive respiratory mechanics using the single breath occlusion COE CHINIGU SS sae de 5 casts e ee sees oa sec Aaaa aaan Tad he aa a a on as Whee g eia iach aa 34 Schematic diagram of infant plethysmography cccccccccecessesssseceeeeseesssssaeeeeees 36 Screen display of plethysmographic FRC recording cccccccsssssssceeecessssssssaeeneees 37 A and B partial expiratory flow volume manoeuvres derived from the tidal Rapid Thoraco abdominal compression RTC technique cc cccccsesseceesssseeeesssseeeesseaees 39 Comparison of partial flow volume loops in health and disease ceceeeeees 41 Forced expiratory manoeuvres using the raised volume technique 006 42 CareFusion Masterscreen BabyBody Plethysmograph ccccccceeeseeeseeeees 47 Rendell Baker Soucek face masks of different SIZES cc ceeeessceceesteceeeenaeeeeeeaes 48 Various sizes of RTC squeeze jacket bladder and large bore tubing for infant forced expiratory MANOCUVIES c cccssssccececessesssnesecececesseseeaeaeeeeecessessaaeeeeeeseesees 50 Left a Neopuff Infant Resuscitator right a T piece tubing ccccsseeeeees 50 A straight connector is inserted to the Neopu
34. introducing PEEP Repeat the procedure to deliver 3 5 augmented sigh like breaths prior to the 2 operator clicking on F3 to activate jacket inflation just before 10 50 ms lung inflation is released to force expiration The timing is crucial between releasing the occlusion at the T piece opening by the 1 operator and the manual trigger of rapid jacket inflation by the 2 operator to obtain technically satisfactory FEFV curves After each RV manoeuvre remove the Neopuff T piece connector from the PNT a respiratory pause is often observed followed by spontaneous onset of tidal breathing Figure 91 NOTE observe the infant s vital signs carefully his her SpO may fall transiently during the respiratory pause It is not advisable to start lung inflations for the next RV trial unless the SpO has returned to baseline and is stable After completion of the first RVRTC manoeuvre check the online results window C Figure 92 to confirm that the actual inflation pressure Pj delivered to the last inflated or squeeze breath was between 2 79 3 09 kPa see sections 6 6 2 and 6 6 3 Flow mls 400 SA Af 1804 spontaneous 1004 tidal breathing Volume ml 504 tidal breathing N 04 passively inflated breaths 604 30 cmH20 respiratory pause following forced expiration pressure plateau at airway opening Jacket inflation 7 Pao kPa Time s Figure 91 Time based trace showing
35. jacket trigger for Raised Volume RTC cccccccccessesssneceeeeesessestsaeeeeeesseeseas 73 3 4 9 4 Setting safety criteria for Raised Volume RTC ccccsccccccecessesssseceeeessessesnsaeeeeeeseeesees 73 3 4 9 5 Contents of Raised Volume RTC result table ceeceeeeeeeseeeeecceceeeeeceaeeeeaeeneaeeeeeeees 74 3 4 10 CareFusion Masterscreen database ccccsessesssscesssecessseeecssneeessceeesaeeeeneeeees 75 3 4 10 1 Creating a patient recorderon i ae ia iaai a i aa ea i ariii 75 3 4 10 2 List of Function keys associated with Patient data program cccccssssceceeeseeeees 78 3 4 11 Preparation and calibration of the Babybody Masterscreen system 78 3 4 11 1 Assembling the PNT components and balloon shutter ssssnsnsseseseseesessesesereessssssesee 79 3 A T1 2 System Warming Upseeri ee e i a ia a E a ia eE 79 3 4 11 3 Checking the condition Of box S al ccccssscccecessessneeceeeeecesseseeaeseeeessessesnsaeeeeeesseeeea 80 3 4 11 4 Preparation and calibration of the pneumotachometer ssssssessseessssssssereesssssseee 81 3 4 11 4 1 Volume calibrati M scienna ai aaa a ike iE 81 3 4 11 5 Preparation for the calibration of the plethysmograph esssssssessssesssssseserrnssssssesee 87 3 4 11 5 T AMBIENT CONGITIONS ehea ee a a A E E a a aaas 87 3 4 11 5 2 Calibration of the plethySMOgraph ccccccccccccssssssssceceeecsssessaeseecesesssesssaeeeseesseeees 88 3 4 11 5 3 Shutter balloon test
36. lung function was normal on this test occasion Further follow up will be arranged when BW is 3 5 4 years of age Reported by xxx 13 November 2013 Page 2 of 2 214 8 10 Backing up making a copy of the CareFusion BabyBody system Database It is advisable for the users of the CareFusion BabyBody equipment to regularly create or back up a copy of the Lab4 database DB e g weekly or monthly The main reason is to safe guard the lung function datasets combined with the Patient details collected over time The computer hard drive may fail unexpectedly resulting in loss of the database or the DB program may crash during data collection the availability of a back up DB could then be utilised to enable continuation of lung function measurements e The CareFusion BabyBody measuring system identifies with the program named as DB as the active database and as Patient record and lung function measurements are created these are continuingly being stored in C Lab4 DB For this reason there should never be more than one folder with the name DB in C Lab4 e However for the purpose of storing or backing up a copy of DB in C Lab4 it is necessary to name the back up copy of DB with a recognisable name e g DB Backup or DB_copy29March2014 such that the active program continue to be named as DB NB in the unexpected event of a DB crash the active DB would need to be re named e g DB_old and the back up copy
37. of infant lung function unless prospective healthy controls are studied Pediatr Pulmonol 2010 45 9 906 913 Stocks J Modi N Tepper R Need for healthy control subjects when assessing lung function in infants with respiratory disease Am J Respir Crit Care Med 2010 182 11 1340 1342 e Cole TJ Wright CM Williams AF Designing the new UK WHO growth charts to enhance assessment of growth around birth Arch Dis Child Fetal Neonatal Ed 2012 97 3 F219 F222 e Cole TJ The development of growth references and growth charts Ann Hum Biol 2012 39 5 382 394 e Cole TJ Williams AF Wright CM Revised birth centiles for weight length and head circumference in the UK WHO growth charts Ann Hum Biol 2011 38 1 7 11 e H lskamp G Hoo AF Ljungberg H et al Progressive decline in plethysmographic lung volumes in infants physiology or technology Am J Respir Crit Care Med 2003 168 8 1003 1009 187 Hoo AF Dezateux CA Hanrahan J et al Sex specific prediction equations for V mayrac in infancy A multi center collaborative study Am J Respir Crit Care Med 2002 165 1084 1092 Jones M Castile R Davis S et al Forced expiratory flows and volumes in infants Normative data and lung growth Am J Respir Crit Care Med 2000 161 2 Pt 1 353 359 7 6 Recent applications of infant LF tests in clinical research using CareFusion BabyBody Masterscreen equipment Hoo AF Gupta A Lum S et al Impact of ethnicity and extreme
38. of rise of jacket pressure e speed of valve opening 10 ms e speed of transmission to jacket 100 ms to reach 95 of final pressure 225 Adjustable squeeze jackets b 3 sizes available for newborn to 2 year old children 2 14 kg Software WINDOWS based software Jaeger Lab4 software package controls data acquisition and analysis All data are stored in a Jaeger Lab4 specific database Data from a single patient or a defined group of patients can be merged out and imported into other databases On line data sampling and reanalysis for each infant lung function program module is based on the structured Jaeger screen display which allows easy orientation and software control All signals may be viewed on the computer screen in real time Specific displays e g plateau of pressure at airway opening Pao during airway occlusions for passive mechanics flow volume loop in RTC changes in Pao vs changes in box volume during FRC ietn measurement may be enlarged to facilitate viewing for quality control Results are available and displayed on line instantaneously and are automatically saved on an interim basis during the testing procedure The user is prompted to save the data definitively when leaving the specific program or study Calibration parameters and BTPS factors are stored with each saved data set performed Signals may be reanalysed later as all raw data are stored on the hard disk While d
39. portions are indicated by the black markings in this example Figure 125 illustrates an example of the effect of glottic narrowing during data collection as shown by FRC 2 with poor phasing or looping window D Consequently the regression slope was skewed to the left in comparison to slopes for FRC O and FRC 1 see figure legend for more details Figure 125 Glottic activity observed during the 3 respiratory cycle represented in green while FRC data were recorded Legend The default for the regression slopes for Act 1 and Act 2 was 10 As can be observed there was a good mask seal d EEL 7 during FRC data collection Window D shows that good phasing for FRC O and FRC 1 by contrast due to glottic narrowing FRC 2 was looping and its regression slope was skewed more to the left compared to those for FRC 0 and FRC 1 Note that the FRC calculated for FRC 2 is also considerably larger by comparison In the presence of glottic activity AP will underestimate AP leading to overestimation of FRC 159 Although it is tempting to eliminate the FRC 2 and simply report the mean FRC using FRC O and FRC 1 which showed good phasing when AP was plotted against AVs the difference between FRC values for these breaths was greater than 10 Figure 125 The 1 breath in blue visually appeared to have the best phasing FRC 231 mL During off line analysis for Act 2 the Regression analysis for FRC was edited
40. pressure Bog re Caneel p pid Press space ber to set 1esesvou pressure Figure 86 Menu for setting the reservoir pressure at the start of each tidal RTC trial Click on F8 if necessary to re set PNT zero flow Click on F2 Start measurement to start data recording Once at least 5 regular breaths have been recorded and a stable EEL established and provided that the P has reached the pre set value F3 icon will be illuminated in yellow 121 indicating that both the software and hardware systems are ready for the user to exercute a RTC manoeuvre e Click on F3 to activate automatic jacket inflation which is synchronised to occur at end inspiration of the next breath Figure 87 window A e Jacket inflation results in compression of the chest and abdomen and is held until the forced expiration is complete or the next inspiration commences As soon as expiratory positive flow crosses zero and switches to inspiratory negative flow the reservoir pressure is automatically vented to atmosphere and the jacket bladder deflated e The PEFV curve and results are displayed Figure 87 windows B and C respectively e For subsequent trials click on F6 to increase P by 1 0 kPa or 0 5 kPa if testing preterm or very young infants maximum increment is limited to 2 KPa between consecutive trials e f there is evidence of airway obstruction scooped expiratory FV loop etc P may be increased more gradually by 0 5 kPa
41. programer e eea orae aa eE EE EREA ESSE Eai 92 Visual check shutter balloon inflation ccccsescecessenceceeseeecesseeeeceseeeaeesseeaaees 93 An error message indicating that a fault has been detected during the shutter balloon test possibly due to a leaking balloon or poor fit of the tube connection between the shutter and control panel s sssssssssssesesressssssesenrrsssssserernesnsssseeens 93 Figure 68 Figure 69 Figure 70 Figure 71 Figure 72 Figure 73 Figure 74 Figure 75 Figure 76 Figure 77 Figure 78 Figure 79 Figure 80 Figure 81 Figure 82 Figure 83 Figure 84 Figure 85 Figure 86 Figure 87 Figure 88 Figure 89 Figure 90 Figure 91 Figure 92 Figure 93 Figure 94 Figure 95 Figure 96 Figure 97 Figure 98 Figure 99 Figure 100 Figure 101 V 1 June 2014 Illustration showing some parts of the Babybody system including the control panel and 2 part support bar for the PNT cccesesssssceeececeseesseaeeeeeeeseesenaeas 105 A face mask connected to the PNT is applied over the nose and mouth of a 2 month old sleeping infant left and a 1 year old infant right 000 105 The screen display for FRCpieth data and results ccc crest seeeteees 107 A sleeping infant breathing through face mask and PNT ccseeseseceeeeeeesees 108 Reminder to perform PNT volume Calibration cccccccccssssssssceceesesssesssaeeeeees 108 Evi
42. pump strokes representing inspiratory expiratory efforts The volume calibration ends automatically after the pre set number i e 6 pairs of pump strokes have been delivered Figure 57 The new calibration or correction factors column New Figure 57 together with previously saved data column Old Figure 57 are displayed to the upper right window Note that when calibration is repeated data for the initial or previous calibration within the same occasion will now be displayed as Old with the repeat current calibration data in column New Although a pump stroke volume within 2 of 100mL i e between 98 102mL is acceptable it is preferable to strive to get volume signals calibrated to within 1 of 100 mL i e between 99 101 mL 84 V 1 June 2014 Provided that volume calibration is performed using the same calibration volume and PNT that had been used as in the previous test very similar quality checks should be displayed on screen between the New and Old columns Figure 57 If a different PNT is used a larger difference is likely to be observed on the first calibration save the initial calibration factors and repeat the procedure until values do fall within 1 2 of 100 mL see Legend for Figure 57 To repeat the calibration procedure click on F9 gt save and restart To end click on F10 to save the final calibration data and exit program CorrIN and CorrEX ar
43. renamed as DB in order for it to act as the active DB a Patient Data record would need to be created before proceeding to continue data collection e A back up copy of DB may initially be create in C and subsequently be copied or transferred to a separate storage media for safe keeping using a USB pen or potable hard drive e Since there is no need to have multiple copies of older versions of DB back up previous copies may be deleted periodically 215 CareFusion Merge program The Merge function enables a the patient details and lung function data in digital not numerical format to be extracted from C Lab4 DB b the merging of data that have been extracted in to a separate Lab4 DB for the purpose of between centre observer audit and or quality control check c the safe storage of the merged out or extracted data at regular intervals Merging data out of an existing Lab4 database Step 1 e The user needs to identify where are the data stored Source data base where are the data being transferred or merged to Destination data base e Anew Destination folder either in a USB pen or portable hard drive must be created to which the extracted or merged out data may be downloaded e Name the folder appropriately so that it is easily recognisable e g Merged data_29March2014 or Data Backup_week 13 Step 2 e Check to see whether the Merge5 icon is on your computer des
44. sedation practitioners should be trained in sedation techniques They should be competent to consent and or prescribe and administer sedative drugs understand the pharmacology of the agents used and be capable of providing Paediatric Basic Life Support and preferably Paediatric Advanced Life Support In some laboratories a paediatrician performs the clinical examination of the infant and prescribes the sedation according to the infant s age and size Informed and or signed parental consent may be obtained by a trained physiologist nurse or technician who then administers 101 V 1 June 2014 the sedation provided that the infant s clinical examination is normal and that his her baseline SpO and vital signs are within expected values 4 4 5 Level of sedation The different levels of sedation stated in the NICE document are based on the original definitions of the American Society of Anesthesiologists ASA and the level required to be achieved for lung function tests is equivalent to the description of moderate level in the NICE 2010 guidelines section 7 2 i e Moderate sedation Drug induced depression of consciousness during which patients are sleepy but respond purposefully to verbal commands known as conscious sedation in dentistry or light tactile stimulation reflex withdrawal from a painful stimulus is not a purposeful response No interventions are required to maintain a patent airway Spontaneou
45. square wave box signal to decay to half its initial value The box t should be maintained between 7 10 seconds to ensure the box is neither too leaky nor too airtight which cause loss of fidelity or instability of the box signal respectively Check that an appropriate actual or estimated body weight is entered in the Patient data record assuming a mean body density of 1 kg L of the infant s weight will be subtracted from the original box volume for the purpose of calculating the calibration factor For the same reason items such as the pulse oximeter and squeeze jacket in use during data collection should also be placed within the Box during calibration NOTE If an estimated weight has been used at the time of box calibration once the infant has arrived in the Lab and weighed the investigator should edit and enter the actual weight in the Patient Data page before LF testing begins Alternatively an estimated value for weight can be corrected later section 3 4 10 1 and Figure 44 3 4 11 5 1 Ambient conditions From the Calibrations tab Figure 51 click to open Ambient conditions Figure 59 87 Ambient cond Lab Number X 05 04 2013 06 04 2013 10 28 48AM 09 01 20AM Range m lt 100 3000 gt Altitude Baro pressure Temperature Rel humidity 300 979 24 hPa lt 500 1200 gt rc lt 0 50 gt A lt 0 100 gt Cancel V 1 June 2014
46. the metal tip first the 2 PNT components and the mesh screen with hot soapy water Figure 95 133 e Rinse under cold running tap water and shake off excess water e Soak the PNT components and balloon shutter in 0 5 concentration of terralin protect solution a disinfectant for medical devices see Appendix for supplier section 8 1 for at least 1 hour Figure 95 The balloon shutter with its metal tip covered before soaking in liquid Legend The shutter with the dissembled PNT comprising 2 white components and the resistive mesh screen e After gt 1 hour remove all the components from the solution and rinse under cold running tap water shake off excess water and leave to dry in room air 21 25 C or dry rapidly using compressed air jet NOTE 0 5 concentration of this solution is made up by adding 5 mL of Terralin protect solution to 1 litre cold tap water or 1 mL per 200 mL of tap water For a list of terralin protect solution contact time against various types of organisms including MRSA and TB please see Appendix and website http www schulke co uk product _ 43 terralin protect accessed 01 Nov 2013 Terralin solution when diluted for use is active for 24 hrs It may be disposed of by pouring it down the sink followed by running cold tap water to rinse off any around the sink plug hole Guidelines provided by CareFusion for sterilising and disinfecting apparatus are available in the Appendi
47. the tidal squeeze manoeuvre Right this diagram illustrates a PEFV curve together with its preceding tidal breath The calculation of V maxerc is shown Window C Figure 83 Screen display for tidal RTC Legend The x y plot of the PEFV curve window B is derived from the data displayed as a time based trace in window A Results together with key quality control outcomes are summarised in window C while the relationship between jacket pressure P shown as circles and resultant flow at FRC shown as squares is displayed in the Trend window Note that during the first 4 trials or Acts no flows at FRC are displayed since this infant inspired early on these occasions before the previously established EEL i e FRC had been reached see section 3 4 8 5 for further details 5 5 1 Application of the RTC jacket the infant lies in the standard supine position with the head supported and neck and shoulder slightly extended over the open jacket Place the inflatable bladder gently over the chest and abdomen so that it may be encased within the outer jacket by fastening the Velcro strips at the front Figure 84 and Figure 85 Check that there is no solid or hard objects between the jacket bladder and the infant s chest abdomen e g zippers necklaces belts buttons The arms remain outside the jacket to avoid any restriction splinting of chest movement Gently adjust the jacket to bring it around the infant s chest and abdomen
48. the upper and lower limits of the normal range ULN amp LLN from healthy infants Page 1 of 2 213 GOSH Consultant GOSH No NAME SEX DOB Study No Gestational age Dr CW 12345 BW female 08 01 2012 53239 41wt id Diagnosis Cystic fibrosis Test Date 12 November 2013 Comments BW s parents reported that she has been well since her last lung function LF tests She was asymptomatic and her clinical examination was normal However her weight and length have remained on the lowed limits of normal ranges Throughout the duration of her LF assessments her SpO and vital signs were stable Summary of lung function follow up On this test occasion BW s lung clearance index LCI an indication of ventilation inhomogeneity and hence early lung disease was within normal limits Her resting lung volumes FRC obtained using the MBW FRCypw and plethysmographic FRCpieth techniques were within the expected ranges There was no evidence of pulmonary hyperinflation or gas trapping Results from the raised volume technique infant spirometry suggested that her forced expired volumes FEV 95 a measure of central and peripheral airway function and FVC a measure of lung volume and forced expired flows FEF 5 75 an indicator of airway obstruction were normal Compared to her 1 year old lung function measurements her LCI has remained stable and there was an improvement in her FEVo s and FEF2s 75 z scores Overall BW s
49. time count down of 20 minutes of system warm up time e Once the 20 minute warming period is completed the software opens to the LabManager V4 67a Main group tab Figure 18 3 4 11 3 Checking the condition of box seal e While waiting for the system to reach thermal equilibration check the rubber seal around the Plexiglas hood for cracks scratches or other damage e Once the hood is lowered to close the box check that the magnetic seal is strong and firm 80 V 1 June 2014 NOTE a simple test to check the tightness of the seal is to gently attempt to push through the corner of a sheet of paper around the perimeter of the closed box The paper will only pass through if the seal is inadequate 3 4 11 4 Preparation and calibration of the pneumotachometer Calibration also known as static response describes a predictable relationship normally linear between the electrical output of the pressure transducer and the magnitude of the physical parameters over the full range of the physical change e The PNT with the balloon shutter in situ Figure 48 is calibrated using a calibrated operator controlled syringe or pump to deliver a known volume e g 100mL which is differentiated to yield a flow signal e The solid state pressure transducer used to measure changes in airway opening pressure P30 is extremely stable and not calibrated on a regular basis e Equipment calibration is conducted under identical cond
50. to 5 and 15 on separate occasions in attempts to modify the regression slope However these options did not improve the fit of the regression line When the Regression analysis for FRC was further adjusted to 18 in order for the regression line to avoid the looping Figure 126 the slope improved NOTE It must be emphsised that with the Regression analysis for FRC edited to 18 the regressed portion becomes somewhat smaller Figure 126 though the slope obtained seem appropriate This approach is not recommended unless additional data are available to support or validate results Figure 127 see legend for further details Regression analysis for FRC Excluded portion of slope Pao 18 m FRCp 0 232 5mL m FRCp 1 202 5mL m FRCp 2 227 9mL FRCp 221 0mL Box volume 20 15 10 5 0 Figure 126 FRC results when the Regression analysis for FRC was adjusted to exclude the upper and lower18 Legend The regression line now appeared to fit more appropriately with FRC values that were more reproducible 160 Best Act Act2 Act3 Act4 232 8 215 0 5 3 0 8 0 12 32 Best Act2 Act3 Act4 214 9 Figure 127 Additional technically satisfactory FRC data to support values for reporting Legend Panel A show data for Act 1 prior to the accompanying Act 2 which is shown in Figure 125 and in Figure 126 following modification to the FRC slopes additional trial was recorded and illustrated in panel B
51. to menu bar select Settings gt FRC Figure 29 The appropriate criteria are shown in Figure 29 In this example within the panel relating to Dead space it can be seen that in a previous test a size 2 mask had been selected and used for data recording total mask dead space 20 mL effective mask dead space 10 mL also see section 5 4 2 When the shutter balloon is activated by clicking on F3 The balloon is set to inflate at the end of an inspiration this is because Infants and young children tend to tolerate airway occlusion better at a higher lung volume end inspiration rather than at lower lung volume end expiration The balloon is set to deflate automatically a after a maximum airway occlusion time of 10 seconds or b after 3 complete respiratory efforts have been detected during airway occlusion The latter set as an additional open conditions indicated by the red rectangle in Figure 29 means that in younger infants who have a higher respiratory rate the shutter balloon will deflate automatically as soon as 3 respiratory cycles inspiratory and expiratory swings have been completed even though the duration of the airway occlusion is lt 10 s 63 V 1 June 2014 e 10 to 15 breaths should be recorded after the release of airway occlusion to allow re establishment of a stable EEL a younger infant usually requires a longer period to resume stable EEL Settings FRC FRC occlusion Activat
52. trial 3 4 8 5 Setting criteria for the tidal RTC occlusion e During a squeeze manoeuvre the jacket may be triggered to inflate to force flow The program permits the user to select either the Synchronized or Manual mode e To select an option go to the menu bar select Program gt Modify settings return to the menu bar select Settings gt Trigger settings Figure 34 e Click on the radio button labelled Synchronized Figure 35 e For the tidal squeeze manoeuvres the Synchronized option mode is preferable During data collection once the F3 icon is triggered or pressing the space bar the jacket will inflate automatically at end inspiration of the next tidal breath e Ifthe Manual mode was chosen as the default setting jacket inflation will occur whenever the operator clicks on F3 icon Therefore the exact timing of triggering jacket inflation at end inspiration of a tidal breath is vitally crucial in order to obtain technically acceptable partial forced expiratory flow volume curves see Section 6 5 2 for quality control criteria 68 Baby Tidal Squeeze V4 67a Dummy Dummy 10001 New test GA Measuring system BabyBody S Shutter balloon test Medication none 7 Reservoir pressure Trend view Axis scaling Measurement rif FIK Trigger settings Warnings Pressure transmission Parameter list Read Save as Delete V 1 June 2014 Settings Trigge
53. you give consent Please ask the researcher any questions you may have about this project before you decide whether you wish to participate If you decide now or at any other stage that you do not wish your child to participate in the research project that is entirely your right and if your child is a patient it will not in any way prejudice any present or future treatment You will be given an information sheet which describes the research project This information sheet is for you to keep and refer to Please read it carefully If you have any complaints about the way in which this research project has been or is being conducted please in the first instance discuss them with the researcher If the problems are not resolved or you wish to comment in any other way please contact the Head of the Research and Development Unit Institute of Child Health 30 Guilford Street London WC1N 1EH or if urgent by telephone on 0207 905 2179 Please initial boxes confirm that have read and understand the information sheet dated 29 05 2009 version 3 for the above study have had the opportunity to consider the information ask questions and have had these answered satisfactorily understand that my participation is voluntary and that am free to withdraw my child at any time without giving any reason without his her medical care or legal rights being affected understand that relevant sections of my child s medical not
54. 0 Section 6 5 2 NOTE The jacket inflation during a squeeze manoeuvre is automatically released after a pre set defined duration between 2 to 3 seconds The maximum jacket compression time should be set to at least 2 0 seconds Note the default is 1 2 s which is insufficient for some infants to complete forced expiration In older infants or young children and those with airway obstruction the Max compression time may need to be greater than 2 s 3 4 8 4 Setting the reservoir pressures for tidal squeeze manoeuvres e The setting of reservoir pressure during data collection is enabled by clicking on F6 setting for pressure e In general a P of 3 kPa is selected to start the tidal squeeze test Figure 33 and this is increased by 1 kPa for each subsequent squeeze manoeuvre until flow limitation is achieved maximum increment is limited to 2 kPa between consecutive trials However in the case of a young or preterm infant being tested an initial P of 2 kPa may be more appropriate and pressure increased more gradually for example by 0 5 kPa rather than 1 kPa for subsequent manoeuvres particularly if there is evidence of airway obstruction 67 V 1 June 2014 Menu bar Settings reservoir pressure xJ Present reservoir pressure setpointis 0 0 Ps 5 Set new reservoir pressure 30g Pa Figure 33 Settings reservoir pressure menu enables an appropriate pressure to be selected prior to each
55. 1 4 291 317 Baldwin D Pillow JJ Stocks J et al Lung function tests in neonates and infants with chronic lung disease Tidal breathing and respiratory control in infancy Pediatr Pulmonol 2006 41 391 419 Schmalisch G Wilitzki S Roehr CC et al Development of lung function in very low birth weight infants with or without bronchopulmonary dysplasia longitudinal assessment during the first 15 months of corrected age BMC Pediatr 2012 12 37 Roehr CC Wilitzki S Opgen Rhein B et al Early lung function testing in infants with aortic arch anomalies identifies patients at risk for airway obstruction PLoS ONE 2011 6 e24903 Kozlowska WJ Bush A Wade A et al Lung function from infancy to the preschool years after clinical diagnosis of cystic fibrosis Am J Respir Crit Care Med 2008 178 42 49 Hoskote AU Castle RA Hoo AF et al Airway function in infants treated with inhaled nitric oxide for persistent pulmonary hypertension Pediatr Pulmonol 2008 43 224 235 188 7 7 Applications in clinical research using other ILFT equipment Peterson Carmichael S Rosenfeld M Ascher SB et al Survey of Clinical Infant Lung Function Testing Practices Pediatr Pulmonol 2014 49 126 131 Debley J Stanojevic S Filbrun AG et a Bronchodilator responsiveness in wheezy infants and toddlers is not associated with asthma risk factors Pediatr Pulmonol 2012 47 421 428 Spoel M van den Hout L Gischler SJ et al Prospective longitudinal ev
56. 3 Passive respiratory mechanics total respiratory compliance C and resistance R E E EEE EEE E E EE E E A E 113 5 3 1 Tostart data collection for passive respiratory MEChHANICS ccccceseeeeeeees 113 5 4 Measurements of plethysmographic lung volume FRCpleth secceecceteereeereeseeeeeeeeae 113 5 4 1 Prior tO FRO pict recording sacris n nnana naeunnan a naaa n i 114 5 4 2 Selecting mask dead space for FRCpicth MeasUreMEntS s ssssseseeseeseessrseeees 114 5 4 3 To start airway resistance recording cccccccecsessssceceeeeecessssseaeeeceesesseessaees 115 SAA To start FRC seh data recording sssssidescessat cases et heat aptnsaaeavet euggeveaseonyandantentatags 116 V 1 June 2014 5 5 Measurements using the tidal RTC technique ccccccsesssceceeeeessessaeeeeeeessssesseaeees 118 5 5 1 Application of the RTC jacket cccccssssececessseeececssaececsssneeecesseeeeeeeesaaeeeees 119 5 5 2 Fo start tidal RTC data recording sscsicccocasetercesvetceseteearentturecsnarnivenasictepeaneens 120 5 5 3 Assessing jacket compression pressure transmission c ccccccceeeseessneees 123 5 6 Measurements using the Raised Volume RTC technique cceceesessceeeeeeessesseaeees 125 5 6 1 Raised Volume forced expiratory manoeuvres cccccccccecessesseseeeeeeeeessessaees 125 5 6 1 1 Raised Volume RTC equipment set up cccccccccccesssssssececeeecessessaeseeeescessesenteseeeesens 125 5 6 1 2 T
57. 4kg and such measurements may be unreliable due to poor signal to noise ratio e Tidal breathing and passive mechanics may be feasible in smaller babies provided that the XS pneumotach PNT is used Figure 52 e Forced expiratory manoeuvres using tidal RTC or squeeze technique have been applied in preterm babies from 2 kg body weight both the tidal and raised volume RTC have been used in infants born at term gestation from 4 6 weeks postnatal age who are at least 2 kg in weight 1 5 Equipment requirements Users and potential purchasers of infant lung function equipment must ensure that it meets the basic requirements specified by the European Respiratory Society American Thoracic Society ERS ATS Task Force including the ease with which it can be cleaned between every subject and that results are interpreted in relation to appropriate equipment specific reference equations or healthy controls studied with identical equipment see section 6 7 and section 7 5 The selected device also must be appropriate for the intended measurement conditions and body size The BabyBody device has not been validated for use in infants receiving assisted ventilation Given the time consuming nature of these investigations and the impossibility of repeating measurements in the event of equipment failure attention to detail with respect to calibration regular maintenance of equipment and a good supply of spare parts are even more essential when as
58. 5 are 25 and 4 respectively This demonstrates that caution is necessary when reviewing or auditing data 6 6 5 Reporting results In contrast to tidal RTC when mean V maxerc is reported due to potential variability of FRC EEL FVC FEV and FEFy from the best technically acceptable Raised Volume FEFV curve i e that with the highest sum of FVC and FEV 4 Inall for quality control purposes there should be 3 minimum 2 valid curves that are reproducible results from the 2 highest within 10 of each other 178 6 7 Interpreting results the role of reference equations 6 7 1 Reference equations anthropometry Growth restriction may have an adverse influence on lung function and affect interpretation of results Therefore as part of any clinical report it may be helpful to document height and weight adjusted for sex and age using WHO reference equations published by Cole et al 2011 2012 Appendix section 7 5 6 7 2 Reference equations lung function results In order to identify the nature and severity of any underlying pathophysiology in an individual it is essential to have a clear idea of what range of values to expect in a healthy child of similar age sex body size and ethnic group Consequently reliable interpretation of pulmonary function results relies on the availability of appropriate reference data to help distinguish between health and disease The use of inappropriate reference equations and
59. 5 passively inflated breaths and timing of jacket compression during a raised volume RTC manoeuvre 128 NOTE If P is lt 2 8 kPa or gt 3 1 kPa then the air flow to the Neopuff system must be adjusted accordingly after ensuring that the Neopuff T piece connector has been disconnected from the PNT mask Check the Neopuff PIP setting repeatedly while adjusting the medical air flow section 5 6 1 2 Re connect the Neopuff T piece to the PNT mask and continue data collection Since the recorded data fail to meet quality control criteria due to inappropriate P the operator may choose to discard the data click on F9 and the No option for Saving data prior to starting new measurements Best Acti Act2 Act3 Act4 Act5 FEV FC 413 2 413 2 FEV 4 177 8 177 8 FYC 235 4 235 4 FEV 5 199 7 1937 FEV 75 2288 2288 Volume i FEVI tidal breaths FEF75 228 0 2280 F25 75 362 2 3622 ogi 091 678 678 54 54 70 70 295 295 167 6 167 6 Window C Figure 92 Screen display at completion of a raised volume manoeuvre Legend The squeeze manoeuvre was undertaken when the last or squeeze breath window A was inflated with a PIP P of 2 95 kPa and the inflated breath volume Vj was 167 6 mL window C The corresponding forced expired flow volume curve shown in window B is also graphically represented in window D by the blue symbols solid square FEV FVC in mLs left vertical axis solid circle jacket pressure
60. E 3 83 Pj transmission Window C Figure 88 An example of assessment of jacket pressure transmission during RTC Legend The time based trace in window A illustrates the change in pressure measured at the airway opening during a brief airway occlusion prior to P1 and during P2 jacket inflation e The jacket transmission is calculated by subtracting P2 from P1 delta P2 P1 results are displayed in the results window as absolute value Pao and as percentage Pjt NOTE in healthy infants it has been recommended that P should be at least 2 kPa but should not exceed 3 kPa Sly et al 2000 section 7 4 4 whereas it may be lt 2kPa in infants with airway disease in whom flow limitation is achieved at lower intra thoracic pressures e At least one technically satisfactory trial to assess transmission pressure should be obtained e When sufficient data have been recorded click on F10 to Save and exit program NOTE If the intention is to continue with the Raised Volume RTC manoeuvres provided that the placement of the PNT mask and the seal remain satisfactory only the balloon shutter needs to be carefully removed without waking the infant This is carried out in readiness for the Neopuff T piece to be connected to the PNT for passive lung inflation during the RVRTC manoeuvres 124 5 6 Measurements using the Raised Volume RTC technique Despite being a popular method for assessing airway function during infancy
61. Figure 59 Window displaying ambient conditions Legend Data saved on previous test occasion as indicated by the red circle are shown along the left column e Record the barometric pressure room temperature and relative humidity on relevant test questionnaire alternatively press PrtScn key see section 6 1 1 for further information to print a paper copy and store in the infant s document folder Click F10 to save and exit Note Barometric pressure usually 700 1100 hpa Room temperature maintained between 20 25 C Relative humidity usually 30 55 e Details of the ambient conditions are used to formulate the correction factors for calculating recorded FRC values e Since incorrect or imprecise ambient data are likely to result in incorrect measured FRC results ambient condition data must be checked prior to each test session Ambient conditions may be checked using basic home weather stations 3 4 11 5 2 Calibration of the plethysmograph e Ensure that doors and windows are closed to minimise draughts and noise i e similar to conditions during data collection e The plethysmograph should not be exposed to direct sunlight or source of heat e g a radiator e Check that relevant apparatus e g pulse oximeter RTC jacket or other items a small blanket that are required during data recording are included within the Box 88 V 1 June 2014 Note check that the rubber stopper is fi
62. Figure 84 When purchasing the BabyBodyMaster screen system with the Squeeze RTC software program 3 sizes XXS XS S of jackets each a non stretchable width adjustable band with Velcro and zipper fastenings together with inflatable bladders and a large bore tubing for connection to the bladder will be provided by manufacturer for performing the RTC or Squeeze manoeuvres Figure 14 see Appendix for supplier section 8 1 49 V 1 June 2014 Figure 14 Various sizes of RTC squeeze jacket bladder and large bore tubing for infant forced expiratory manoeuvres 3 2 5 Specific accessories for the Raised Volume Squeeze In addition to the squeeze jacket bladder and large bore tubing an infant T piece resuscitator is required during the raised volume squeeze manoeuvres see below 3 2 5 1 Neopuff Infant T piece Resuscitator Fisher Paykel Healthcare e This apparatus allows a pre determined peak inspiratory or inflation pressure PIP to be set In accordance to international consensus ATS ERS guideline 2005 section 7 4 4 a PIP of 30 cmH O is recommended for the raised volume forced expiratory manoeuvres see Appendix for supplier section 8 1 Cap for PEEP function Figure 15 Left a Neopuff Infant Resuscitator right a T piece tubing 50 V 1 June 2014 e The cap for PEEP function from the T piece resuscitator tubing is removed Figure 15 right Figure 16 left e One end o
63. Goetz Hoo AF Lum S et al Assessment of passive respiratory mechanics in infants double versus single occlusion Eur Respir J 2001 17 3 449 455 Stocks J Sly PD Morris MG et al Standards for infant respiratory function testing what ever next Eur Respir J 2000 16 4 581 584 7 4 3 Plethysmography Kirkby J Stanojevic S Welsh L et al Reference equations for specific airway resistance in children the Asthma UK initiative Eur Respir J 2010 36 3 622 629 Broughton S Rafferty GF Milner AD et al Effect of electronic compensation on plethysmographic airway resistance measurements Pediatr Pulmonol 2007 42 9 764 772 Erratum in Pediatr Pulmonol 2008 43 1 104 Subbarao P Hulskamp G Stocks J Limitations of electronic compensation for measuring plethysmographic airway resistance in infants Pediatr Pulmonol 2005 40 1 45 52 Stocks J Godfrey S Beardsmore C et al Plethysmographic measurements of lung volume and airway resistance ERS ATS Task Force on Standards for Infant Respiratory Function Testing Eur Respir J 2001 17 2 302 312 186 e Coates AL Peslin R Rodenstein D et al Measurements of lung volume by plethysmography Eur Respir J 1997 10 6 1415 1427 7 44 Tidal and raised volume RTC e LumS Stocks J Forced expiratory manoeuvres In Merkus P Frey U eds Paediatric lung function ERS Journals Ltd 2010 46 65 e ATS ERS statement raised volume forced expirations in infants guidelines for curr
64. Measurement criteria settings for the Raised Volume RTC csessessneeeeees 72 The Manual mode for triggering jacket inflation is preferred for the Raised Volume RTC Manoeuvre cccccecsesecesseececeeseeeeceeseeeeceseeeeeceeceeeecseseaeecsseeaaeeeesenaees 73 Default settings for safety criteria for the Raised Volume RTC technique 74 Selected Raised Volume RTC variables for display in the result window 74 LabManager V4 Main group Patient Data page ecccesssscececeeesssssteeeeeees 75 An example of an existing patient file being retrieved c ccccccccssssssteeeeeeeeeees 76 Test directory showing a list of data saved in the Masterscreen database The red circle indicates Info DUTCON 0 cccccccccccecececesecececeseseceeeeeeeceeeseeeeseeeeness 77 Save button in the Test Information panel is highlighted by the red circle 77 Screen option allowing the user to accept and save the modified data The red circle highlights the Exit button c ccccccccsssssssececeeeceesesseaeeeceessessessaeeeeeesseeseaaeas 78 Assembling PNT components and balloon shutter to CareFusion sensor 79 The BabyBody Masterscreen system main interface The Lab 4 icon is indicated by thesred circles sess Seis OAM Mi eet A ea S 80 Start up page with automatic real time count down of 20 minutes of system warm Up TIME ceils nati ee ae a e aa a cnet aae eae bidaetelteds ath stedetectees 80 Ca
65. Notice that mean FRC values from both panels A and B are similar to that shown in Figure 126 after modification was made to the regressed portion for the slopes and whether FRCp 2 was included or deselected from final calculation i e 221 0 mL or 217 5mL respectively 6 4 5 Reporting results e mean FRCpietn should be calculated and reported from 3 5 technically acceptable trials e in exceptional cases FRCpieth may be reported from 2 reproducible acceptable trials each comprises at least 2 respiratory efforts with good phasing and are reproducible to within 5 of each other 161 6 5 Analysis and reporting of tidal RTC data In addition to the usual time based flow volume and result windows the tidal and raised volume forced expiratory programs display a trend window offering the user an overview of all trials performed including P transmission assessment Figure 88 6 5 1 Main outcomes y V maxFRC Secondary outcomes include 6 5 2 6 5 3 Optimal P at which flow limitation was identified i e with increasing P no further increase in forced flows is elicited The optimal P is used for RV squeeze manoeuvres Pj transmission as a quality control assessment Criteria for acceptability no evidence of leak during data collection Rapid rise time at start of forced expiration with the peak forced expiratory flow being attained before 30 of tidal volume has been expired Length of Pj compression tim
66. Print SCrn key e To enable printer function i e disable the screen dump function go to the LabManager main page Figure 18 from the menu bar click on Option and check that Printer option is ticked e To disable the printer function i e enable the screen dump function go to the menu bar click on Option and make sure that Printer option is not ticked NOTE To screen dump a screen display open a new WORD sheet in the background while reviewing analysing data go to the selected screen display press PrtScrn key return to the WORD sheet and paste hold down Ctrl and press V the screen display electronically to the WORD sheet Remember to return printer function to enable mode once document is completed 6 1 2 Retrieving and identifying stored data for analysis e From LabMan Main group open the required test program e g Tidal Breathing Analysis Figure 18 e Goto Menu bar click on Program gt Reanalyze old measurement Figure 97 136 E Tidal 4 60 4 0 apie settings Measuring system BabyBody S Medication Figure 97 Tidal Breathing menu enabling retrieval of stored data for review and or reanalysis From the Test Directory click on and highlight the required sub set of data according to test date time and type e g TIDA for tidal Figure 98 e Click on OK to open and display the selected data Test directory x 10
67. Tests 21 05 2012 21 05 2012 4 23 01 2013 5 2370172013 14 28P 6 23 01 2013 14 30P 7 23 01 2013 14 36P 8 23 01 2013 14 38P 9 1271172013 11 10A 10 1271172013 11 18A ee a M _ _ Cone Figure 98 Test directory showing stored data according to test data time and type of measurements as indicated by the red rectangular box During data recording the software applies a drift correction to the tidal breathing data as each trial is completed and displays the online analysis in the upper right window on Figure 99 Click on the colour trial button Figure 99 one at a time to perform off line inspection and application of quality control criteria to each trial of tidal breathing 137 1003 Tet Tex 888 8 8 82 8 8 6 Figure 99 The red circle indicates the 2 trials or Acts of tidal breathing data saved to the database If appropriate click on F9 to save the modified data go to Program gt Reanalyse old measurement and select another sub set of stored data from Text Directory to review analyse repeat the procedure until all the data have been reviewed analysed click on F10 to save and exit To continue on to review and analyse another dataset open the appropriate test program e g Res Compliance or Tidal Squeeze retrieve the appropriate stored data from Test Directory as described above 138 6 2 Analysis and reporting of tidal breathing data 6 2 1 Main outcomes
68. The jacket should extend from the level of axillae to the symphysis pubis and should fit the infant s thorax snugly while allowing sufficient space at the sternum to accommodate insertion of at least 3 4 adult fingers allowing inflation of the bladder during testing 119 However a fitting that is too loose means much higher jacket pressures are needed due to poor transmission of jacket inflations Pressure relief valve Pneumotachometer Reservoir tank Figure 84 Schematic diagram showing the inflatable bladder securely held in place by the outer jacket connected to the pressure reservoir tank by a large bore tubing 5 5 2 To start tidal RTC data recording Select Squeeze in the LabMan main program page Figure 18 Click on F1 to continue monitoring breathing pattern display in the Monitor window Ensure that one end of a large bore tubing is connected to the opening situated next to Control panel linking it to the reservoir tank while the remaining end is connected to the inflatable jacket Figure 85 Click on F6 setting for pressure to set a new reservoir pressure P Figure 86 In general 3 kPa is selected to start the tidal squeeze test unless a young preterm infant is being measured in which case 2 kPa may be used as the initial P to obtain a partial forced expiratory flow volume PEFV curve 120 Menu bar Present reservoir pressure setpointis 0 0 kPa Set new reservoir
69. V 1 June 2014 Manual of Infant Lung Function Tests Version 1 0 June 2014 Ah Fong Hoo Sooky Lum Joerg Mattes Janet Stocks Respiratory Critical Care amp Anaesthesia Section Portex Unit UCL Institute of Child Health Respiratory Medicine Unit Great Ormond Street Hospital for Children NHS Foundation Trust London England UK and gt NSW infant Lung Function Centre Newcastle Australia V 1 June 2014 Conditions of use This work is licensed under a Creative Commons Attribution NonCommercial NoDerivatives 4 0 International License Under the following terms e ATTRIBUTION You must give appropriate credit provide a link to the license and indicate if changes were made You may do so in any reasonable manner but not in any way that suggests the licensor endorses you or your use e NONCOMMERCIAL You may not use the material for commercial purposes e NODERIVATIVES If you remix transform or build upon the material you may not distribute the modified material e NO ADDITIONAL RESTRICTIONS You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits Copyright of all materials including photos and illustrations remain with the authors V 1 June 2014 Conditions of Use By using the manual you confirm that you have read and accept the following conditions of use and that you agree to comply with them
70. VC has been exhaled mL s e g FEFz5 FEF 35 75 flow measured during the mid portion of the forced expiration mL s when 25 to 75 of the FVC has been exhaled FVC forced vital capacity mL FRC functional residual capacity i e resting lung volume at end mL expiration FRC pieth FRC assessed using the body plethysmograph mL GA gestational age weeks HBR Hering Breuer inflation reflex Hz hertz unit of frequency hPa hectapascal 10 hPa 1 kilopascal 19 V 1 June 2014 Abbreviation Symbol Description Unit kPa kilopascal Kg kilogram L litre LF lung function min minute mL millilitre MOT multiple occlusion technique mmHg millimetre of mercury O oxygen P pressure kPa cmH O Paw alveolar pressure kPa cmH O Pas pressure at the airway opening i e mask mouth and nose kPa cmH O PEEP positive end expiratory pressure kPa cmH O PEFV partial forced expiratory flow volume curve Pel elastic recoil pressure kPa cmH O Ping airway inflation pressure kPa cmH O PIP positive inspiratory pressure kPa cmH O Pj jacket pressure kPa PMA post menstrual age weeks PNA postnatal age Weeks months decimal years cPNA postnatal age corrected for gestation Weeks months decimal years PNT pneumotachometer pneumotach Pbox box plethysmographic pressure kPa QC quality control Raw resistance of the airways kPa L s Reff effective resistance of the airways kPa L s RDS respiratory dist
71. Window A time based trace Pao kPa Window B delta Po vs delta Vg E FRCp 0 163 0 mL E FRCp 1 159 0 mL E FRCp 2 159 9 mL FRCp 160 7 mL Box volume change ml 5 4 3 2 1 0 4 2 3 4 5 Figure 8 Screen display of plethysmographic FRC recording Legend Window A shows time based trace for FRCpietn data The graphical presentation of changes in box volume and changes in pressure at the airway opening for the 3 respiratory efforts recorded during the occlusion are shown in window B Since the initial pressure P in the lungs at time of the occlusion is known to approximate atmospheric i e barometric pressure and both the changes in lung volume and change in alveolar pressure can be measured from changes in box volume AV and pressure changes at the airway opening AP respectively Figure 8 the initial volume V1 can be calculated 37 V 1 June 2014 After correction for apparatus dead space and any volume inhaled above the EEL at the time of the occlusion V equates to FRC Thus in its simplest form FRCyieth AVe AP x barometric pressure The reader is directed towards detailed descriptions of plethysmography to grasp a fuller understanding of the basic principles involved the underlying assumptions and the various correction factors that must be applied to ensure accurate assessments section 7 4 3 Full details of data collection quality control criteria for meas
72. a lt 2 deviation from 2 94 kPa or 30 cm H20 171 Best Act Act2 Act3 Act4 ActS 1104 3737 730 3 289 289 5916 5916 Figure 139 RVRTC trials may be viewed individually left panel or as trend of composite trials right panel Legend Left panel window A1 shows time based data of the A trial right panel window A2 illustrates data plotted as volume mL versus time s of valid or selected trials This example shows that due to irregular tidal breathing at the start of the 4 trial window A1 several more breaths were recorded to ascertain a stable EEL prior to raising lung volume towards TLC before the RVRTC manoeuvre Ideally data recording should be continued until spontaneous tidal breathing is re established post RVRTC manoeuvre However limited software memory led to cessation of data recording during the respiratory pause window A1 Hence continuous monitoring of vital signs throughout the test duration is important allowing constant observation of the infant s wellbeing As illustrated in Figure 139 window A1 4 trial denoted by red symbols time based data are usually displayed for a specific trial by clicking on either the square or round symbol which corresponds to the individual RVRTC trial in the trend window 172 e However by clicking on F7 the time based screen can be switched to display a composite of valid trials as shown in window A2 Figure 139 In this example for clarity only 2 val
73. able Pred Best Act2 Act3 Act4 Act5 11 01 T 3003 Volume ml RR 27 2 27 0 163 0 17 5 5 16 0 904 0 919 54 glottic activity mid expiration Mouth pressure kPa Mouth pressure 200 400 600 800 1000 1200 1400 1600 Figure 114 Screen display illustrating the effect of glottic activity on the expiratory limb during a SO trial f Pao plateau Infants with airway disease may require a slightly longer duration for pressure to equalise within the lungs during an airway occlusion therefore when testing such infants the Max occlusion time may need to be increased Figure 113 Conversely if frequent early inspiratory effort was occurring during SO measurement check to ensure that the default for Max occlusion time is not too long Figure 113 Examples of both a poor and relaxed plateaux at the airway opening are illustrated in Figure 115 149 Figure 115 Examples of P plateau recorded during SO measurements Legend Left panel no relaxed P plateau observed during occlusion suggesting poor pressure equilibration within the lungs and or expiratory effort during the occlusion Right panel Pao rises rapid and smoothly during an occlusion indicating rapid pressure equilibration within the lungs enabling the recording of relaxed plateaux at the airway opening 6 3 5 Reporting results mean values for C and R are calculated and reported from 3 5 technically acceptable manoeuvres in exception
74. aececesseeeeceesseeeeseesaaeeeenss 98 4 3 3 1 Questionnaire relevant to lung function tests ssssssessssssseseressrsssserernerrssssesereesessno 98 4 3 3 2 Lung function summary sheet mecneo reri ie A E R N T 99 4 4 Sedatlonienetvieh alvin ewe nen E E alee aoe E AE evi eee A 99 4 4 1 Contra indications for Sedation ccccssscccssssscccessstccessssescecsessececeessaeessess 99 4 4 2 Potential risk factors 3 op cecccctuaiccamcetescn a pawcaehnemenseateten atetedaewends 99 AAS SOC ation dosage nierien are EEEE AAE AEEA as 100 4 4 4 Personnel administrating S Aation ccccccccssssececsssseeecessseececssneeeessseeeees 101 AAS bevel OF sedation oreraa a atanan a aaa aAA aSa 102 4 4 6 Handling of infant following of sedation cc ccceccescsscececeeecsesssteaeeeeeeseneees 102 AAJ Classification Of sle pistate censonis an aa a 103 5 Infant lung function data COMeCTION ccceccsssscesssssceccssssceccsssscescessscesessseeees 104 5 1 Apparatus Safety iSSUCS csscssccccecsesssssensecececsessnnsaesecececsessnasacseceeeesessananseceesess 104 S11 PNT SUPPOPrt bareen ar E EA RN R NER i 104 5 2 Measurements of tidal breathing TB paraMeterS cccccccccesssececsssteeeesesseeeeeeaaes 107 5 2 1 Application of face mask and PNT ccesecccessssceceeesneeecesseeecesseeeeeeeeeaaeeeees 107 5 2 2 To start tidal breathing TB data recording cccscccceesssccceesssseeeeesseeeeees 108 5
75. al to the airway segment subjected to flow limitation This makes it a useful measure of intra thoracic airway function in infants in whom nasal resistance composes a large portion 50 of total resistance As in older subjects both the shape of the loop and the numeric values derived contribute to the interpretation of results Figure 10 40 V 1 June 2014 200 200 109 maxFRC 100 T 2 i E VimaxFRC K Lu 6 fe 4 Volume mL 100 40 20 0 20 40 20 0 20 A Healthy infant B Airway obstruction Figure 10 Comparison of partial flow volume loops in health and disease Legend A In a healthy newborn infant maximal flow at FRC V maxerc is 92 mL s B In an infant of similar age and weight but with evidence of airway obstruction much lower flows are recorded and the descending portion of the expiratory flow volume loop has a characteristically scooped out shape concave to the volume axis 2 6 3 The Raised Volume Technique Despite the popularity of the tidal RTC its value when assessing either baseline airway function or bronchial responsiveness may be limited by the dependence of reported values of V maxerc ON resting lung volume which may be unstable in infants particularly in the presence of disease or following interventions The RTC technique has therefore been modified to allow measurements over an extended volume range using what has become known as the raised volume rapid thoracic abdominal compre
76. al cases reproducible results may be reported from 2 trials 150 6 4 Analysis and reporting of plethysmographic FRC data Currently sRo results are not yet considered to be reliable section 2 5 therefore only analysis of FRCpietn data will be discussed Figure 116 illustrates the various options of viewing the FRC breaths with the view in window B being the most useful A 14 m FRCp 0 293 6mL 14 m FRCp 0 293 5mL m FRCp 1 289 2mL m FRCp 1 289 2mL 2 FRCp 2 291 8mL Da m FRCp 2 291 8mL FRCp 291 5ml 4 FRCp 291 5mL J FRCp 0 293 5mL m FRCp 1 289 2mL 7 FRCp 2 291 8mL FRCp 291 5mL Figure 116 Options for viewing FRC breaths Legend By clicking on the symbols red circle window A the 3 FRC breaths can be viewed in different formats A composite B individual respiratory efforts after drift correction C individual respiratory efforts before drift correction 6 4 1 6 4 2 Main outcomes FRC Criteria for acceptability e no evidence of leak during data collection e During airway occlusion NOTE the flow signal should remain zero i e no flow volume trace stable without fluctuation no obvious decay in Pao which is an indication of leak Figure 117 if the delta EEL pre and post occlusion d EEL is gt 15 following the release of airway occlusion it usually indicates a leak It takes longer for EEL to settle after a FRC occlusion of up to 10s compared to the bri
77. alking they are potentially at greater risk of harming themselves while drowsy following administration of chloral sedative both before and following the tests Thus parents should be advised accordingly to observe the child carefully for 12 24 hours after sedation The Masterscreen system will accommodate a young child weighing up to 14 kg However the user needs to consider which tests are required for instance whether the plethysmograph needs to be closed for FRC measurements 4 2 Organising lung function appointments e Except for infants born preterm or those with clinical conditions who remain in hospital most tests are arranged by telephone on an out patient basis at a time likely to coincide with the infant s daytime nap and feeding pattern 4 2 1 Parental information e An information leaflet outlining the lung function tests and the need for sedation is given to the parents see example section 8 4 e Further information and discussion about the tests are often conducted via the phone between the lung function team members and the parents who are encouraged to ask questions about the tests 95 V 1 June 2014 In addition information regarding the fasting regime associated with chloral sedation see section 4 4 3 is also discussed with the parents i e the infant should not be given any food or milk 4 hours breast milk or water up to 2 hours before lung function tests 4 3 Preparing for lung function t
78. aluation of lung function during the first year of life after repair of congenital diaphragmatic hernia Pediatr Crit Care Med 2012 13 e133 e139 Rosenfeld M Ratjen F Brumback L et a Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis the ISIS randomized controlled trial JAMA 2012 307 2269 2277 Prendergast M Rafferty GF Milner AD et a Lung function at follow up of infants with surgically correctable anomalies Pediatr Pulmonol 2012 47 973 978 van der Zalm MM Uiterwaal CS Wilbrink B et al The influence of neonatal lung function on rhinovirus associated wheeze Am J Respir Crit Care Med 2011 183 262 267 Pillarisetti N Williamson E Linnane B et al Infection inflammation and lung function decline in infants with cystic fibrosis Am J Respir Crit Care Med 2011 184 75 81 Filbrun AG Popova AP Linn MJ et al Longitudinal measures of lung function in infants with bronchopulmonary dysplasia Pediatr Pulmonol 2011 46 369 375 Drysdale SB Wilson T Alcazar M et al Lung function prior to viral lower respiratory tract infections in prematurely born infants Thorax 2011 66 468 473 McEvoy C Schilling D Peters D et a Respiratory compliance in preterm infants after a single rescue course of antenatal steroids a randomized controlled trial Am J Obstet Gynecol 2010 202 544 549 Davis SD Rosenfeld M Kerby GS et a Multicenter evaluation of infant lung function tes
79. an 3Jun2013_J Drives Cancel Figure C To select the Destination folder go to Destination data base click on select to access the drop down Open menu Under Drives click on W to select the drive and location where a new folder had previously been created to allow extracted data to be downloaded to Cancel e PRIVATE Sv Network Test number Settings Essar Destination data base E NoegeBabyBody_08_BackUp_2013 Select Create databare Options Do not mage calitestion patents I techade user kets I techade PatientManager data Comarder date hom 1 1 2013 ui 30 12 2013 Ec Destination data base ENAEGER Z Scores Templates_Sepi2010 Ceste databace Desinsion dete bare EYMAEGER Z Seores Templstes_Sept2010 Select Create database Opera F Donet menge calbeaon patients Ineke uter lists I incide PatertManage date Corais date Do not merge calibeation patients nchade user ets I inchado PatiertManager data Consider date tom ot bom uit Figure D Options of the Merge function i extracting data collected over a period of time by entering specific dates or ii extracting dataset s belonging to one individual infant by entering the subject ID or iii extracting all data from the entire Lab4 Database by leaving the date and patient boxes bla nk Once the Merge option has been decided upon and the appropriate entry made e g
80. anual would not have been possible without the contributions of numerous individuals who have worked in our infant lung function laboratories including Matthias Henschen Georg Hulskamp Anne Cantarella Henrik Ljungberg Amit Gupta Jo Chittenden Robyn Hankin Muriel Albiez Alicia Bolton Deeba Ahmed Lena Thia Thanh Diem Nyugen Lucy Brennan Jane Chudleigh and Joanne Miles V 1 June 2014 Contents Condition OF USC nessi iaieineea Te a AA aa oan ea Sa eaaa aaa dab anaia aaaea aariaa 1 Disclaimer Summary of Manual s sssssesssesssesssseesssssssrersssesestssserersssrsrerseserissesrerssersrerseseresesrres 2 Acknowledgement Sodne roinaa aR ets ads av E A A ahi 4 Table OF Cont ntS aiina a a aa aaa a anaa OMe valerie 6 listor FI SUES 2 3 aa n ua a a a a A a E a a ENNIE 13 EistotTa bles nas e a aa ia va edo tala cea nae Ca nate a 18 List of Abbreviations SVMDOlS s15 csc cic sesaseensbaegs sactioaacd gaptacadess saasacietenieiad tesonsst acm aemusvons 19 Commonly Used Conversion Factors cccccsessessessssssssssssessecesceecessessesseseeseeeceecsesesseseesaeeseeess 22 Glossary OF Term Sasann Seen nae ids hoacdel deioader dpa vee aia es Sas Gaatoes 22 Recommended Reading List c 1s sass scien ai ciewesced decade hada cicbic deioadelieatacaae osaanhadiedanaasneadiaveedaats 185 LIS OF Appendices a sale ces ree soe seeteo ea tae a e a dacs tac nessa a duns Mestalla A an 193 V 1 June 2014 Table of Contents 1 Special considerations whe
81. ask PNT position has been changed at all during data collection click on F8 to re zero flow volume setting as the solid state transducer is very sensitive to position Click on F1 Start of tidal breathing registration to begin data recording Record at least 5 10 regular breaths to establish a stable end expiratory level EEL before performing a test occlusion to check that the mask face seal is air tight If a mask leak is evident Figure 73 the recording must stop the mask and PNT re positioned or removed and re applied over the nose and mouth and sealed with the putty The test occlusion must be repeated to check for leaks Click on F2 to stop a trial or epoch e g after 30 50 breaths During online recording a slight drift in tidal breathing is observed due to differences in the humidity and temperature of inspired and expired air baseline EEL Figure 73 This can be distinguished from the effect of a mask leak by observing the poor overlay of flow volume loops despite an apparent regular EEL and a V of 3 6 mL kg Figure 74 windows B and C when compared to the regular overlay of flow volume loops in the absence of a mask leak shown in Figure 75 lower left window airwayocclusion AAA YY MIVA 5 Figure 73 Evidence of a leak around the face mask Legend This screen display obtained as a screen dump during data recording shows a time based trace of tidal breathing Following a brief airway occlusio
82. ata can be excluded if technically unsatisfactory they are never deleted The user can always revert to the original data and or automated analyses This allows previously excluded data to be re examined modified and recalculated if necessary and provides considerable scope for training and quality control checks 226 A database holds the patients personal and demographic data together with details of prevailing measurement conditions and results of the tests As an option for scientific evaluation measurement signals from the BabyBody programs can in parallel to the measurements be fed into a second independent analysis program Jscope stored as ASCII files and then reloaded either to Jaeger Lab4 or other ASCII based programs for analysis and comparison This feature permits direct comparison of the algorithms used within the Jaeger Babybody software with previously validated infant lung function software NB the Jscope file can be found in C Lab4 3 Major strengths The system provides an user friendly interface which is consistent throughout all programs and is thus easy to operate The system is designed for routine use A range of conventional infant lung function techniques is available Modular format additional or follow up tests can be added to relational database Equipment and software were developed in accordance with ATS ERS consensus statements All data including invalid
83. ate for LFT is 50 100 mg kg body weight section 1 3 2 Table 3 Gaultier et al 1996 section 7 2 and is administered with informed parental consent NOTE chloral hydrate syrup is no longer available in USA Table 3 Dosage of sedation used for lung function tests Test age Chloral hydrate Triclofos sodium lt 44 weeks PMA none given none given Between 4 11 weeks 50 60 mg kg 75 90 mg kg Between 12 weeks 2 years 50 100 mg kg 75 150 mg kg 660 mg of chloral hydrate is pharmacologically equivalent to 1 g of triclofos sodium The maximum dosage given at any one occasion is 1 G of chloral hydrate or 1 5 G of triclofos sodium It has been reported that use of chloral hydrate or triclofos sodium does not affect the strength of the HBR or respiratory parameters in infants Tepper et al 1986 Jackson et al 1991 Rabbette et al 1991 section 7 2 The Infant Lung Function Laboratory at the Great Ormond Street Hospital GOSH for Children NHS Foundation Trust UCL Institute of Child Health complies with the clinical guidelines 112 with respect to sedation in children published by the National Institute for Health and Care Excellence NICE in 2010 NICE Guideline Development Group 2010 section 7 2 4 4 4 Personnel administrating sedation Before administering the sedation confirm and record the time of last food and fluid intake in the healthcare record Safety and success depends upon skill and judgement The
84. aths have been detected and only one AP versus AV loop was satisfactory then this trial would not be considered eligible for reporting 6 4 4 Examples of invalid trials a PNT and or mask leak Figure 121 displays FRC measurements Act 2 in a 1 year old infant As can be seen in window A during the period of airway occlusion Pao recording appears as expected depicting 3 respiratory efforts undertaken by the infant against the closed shutter However on careful inspection both the flow and volume signals are unstable suggesting a leak from the PNT Best Act Act2 Act3 Act4 FRCp 2551 2 2 2340 FRCpCY 109 EELs m FRCp 0 292 6mL m FRCp 1 275 8mL m FRCp 2 314 1mL FRCp 294 0mL Figure 121 This screen display shows an invalid FRC trial from a 1 year old infant Legend The unstable flow and volume signals window A are suggestive of a leak from the PNT and the marked upward shift delta 32 in EEL post occlusion windows B and C indicates a mask leak Variable FRC results were obtained from the 3 individual respiratory cycles against the closed shutter window D When compared to the pre occlusion tidal volume baseline a marked upward shift in EEL post occlusion d EEL 32 was noted indicating a leak around the face mask windows B and C The individual FRC values for the 3 respiratory cycles against the closed shutter are inconsistent window D In the presence of PNT and mask leaks this trial is not acceptable as
85. both the metal tips at the control panel and the shutter and that the PNT pressure transducer lead is correctly slotted into the control panel Figure 48 c sensor ENT Figure 48 Assembling PNT components and balloon shutter to CareFusion sensor Legend a It is essential to ensure that the PNT resistive screen is free from dirt and that all the PNT components and the pressure ports are dry b The PNT screen is fitted snugly between the PNT parts in readiness to be connected to the sensor it is vital that the pressure ports are aligned correctly c The bevelled end of the balloon shutter is inserted to the PNT securely Check that the balloon shutter tubing and PNT electrical lead are connected appropriately to the control panel 3 4 11 2 System warming up e Switch on computer and enter the password e click on LAB 4 icon to open LabManager interface Figure 49 79 V 1 June 2014 e peg Ga Merge Figure 49 The BabyBody Masterscreen system main interface The Lab 4 icon is indicated by the red circle e The Start up System check page opens and kick starts the count down of 20 minutes duration allowing the Masterscreen System to reach thermo equilibration Figure 50 This step is essential prior to calibrating the PNT and Box e Ensure that the PNT is in situ correctly in the sensor housing System warm up Remain time 19 min System check OK Figure 50 Start up page with automatic real
86. ccccccesesssstteeeeeeeeeees 168 This volume time trace shows the calculation of FEV following a raised volume RTC manoeuvre In this example forced expiration was completed by 0 7 s 170 RVRTC flow volume curve illustrating flow partitions in relation to FVC 170 A screen display showing a technically acceptable RVRTC manoeuvre 172 Figure 139 Figure 140 Figure 141 Figure 142 Figure 143 Figure 144 Figure 145 Figure 146 Figure 147 V 1 June 2014 RVRTC trials may be viewed individually left panel or as trend of composite trials right pan eioen oaar ERA TESA SEE 172 A technically valid RV trial from an infant with airway obstruction 173 Raised volume FEFV curve with transient narrowing of the glottis or larynx during forced ex PiratiOn serere ee aii aei ia A REE E eee ante eee 174 Example of a raised volume FEFV curve obtained following late jacket ompression window A eusar anana E RN 174 Effect of delayed jacket inflation during a RV manoeuvre ssssssssseessssesereree 175 An example of a technically unacceptable RVRTC curve ccecesessssteceeeeeeeeees 176 Overlaying 2 raised volume RTC trials for comparison of results cceceeees 177 The blip at the end of the RVRTC curve windows A and B may bias FVC measurement and hence calculations of FEV and FEF ccccceceeceeeeeeeseeeeeeess 178 The red circle in the right upper quadrant indicat
87. cdedeescecdeasecdvedescacdesescGliasescasdeasacediedadeacdesessGldsendecteee 138 Graphic displays of tidal breaths ccccccccsssssssecececscessesseaeseeeeseessesseaeeeeeeseesees 139 Off line analysis of tidal breathing parameter cccsesscececeeessesssteeeeeesensees 140 Figure 102 Figure 103 Figure 104 Figure 105 Figure 106 Figure 107 Figure 108 Figure 109 Figure 110 Figure 111 Figure 112 Figure 113 Figure 114 Figure 115 Figure 116 Figure 117 Figure 118 Figure 119 Figure 120 Figure 121 Figure 122 Figure 123 Figure 124 Figure 125 Figure 126 Figure 127 Figure 128 Figure 129 Figure 130 Figure 131 Figure 132 Figure 133 Figure 134 Figure 135 Figure 136 Figure 137 Figure 138 V 1 June 2014 Note coefficient of variability CV of tidal breathing data ccccccseseeeeees 140 Summary of tidal breathing paraMeters ccccccccccscsssessseceeeeseeeseseseeseeeeseesees 141 Passive mechanics data obtained using the single occlusion technique 143 For clarity a single technically acceptable trial obtained using the SO technique IS Mustrate d enrii A cts dan ad wTeateeves E eet enad OANA i a 144 Results table for passive MEChHANICS cccccssccccssssecececsnececeeceeecseqeeeeeenaeeeeseaas 144 Relaxed expiratory phase from 3 single occlusion trialS cccccccccessessreeeeeees 145 An invalid example of SO test due to active exp
88. ce the portion between Vol A and Vol B indicates the limits of linear regression analysis for calculation of flow volume regression line t default setting set to analyse over 55 5 volume of the expired breath back extrapolation of t to zero flow indicating pseudo flow at moment of airway occlusion forward extrapolation of t to zero flow represents the volume to which the infant would have exhaled passively if a premature inspiratory effort had not occurred i e EEV Vic volume intercept representing the extent to which functional residual capacity is dynamically elevated Vex extrapolated expired volume i e the volume of air in the lung at moment of occlusion above the passively determined EEV Veocc expired volume after release of the occlusion Right panel shows a pressure time trace P1 represents the mean pressure plateau measured at the airway opening during airway occlusion indicating the elastic recoil pressure at time of occlusion 6 3 3 Criteria for acceptability no evidence of leak during data collection occlusion time of 1500 ms flow volume curves have an expiratory portion in which a linear regression line i e a single time constant through 50 of expired volume program default preset to analyse over the range 55 5 volume remaining in the lung above the EEL see section 3 4 5 and Figure 104 that can be fitted with a coefficient of determination r2 of at least 0 99 a relaxed pressure plateau at t
89. ce and FRC when expressed as a simple ratio of body length or weight at specific ages throughout the first 2 years of life Age Weight Length VT Vr Cis Cis FRC FRC wks kg cm mL kg mL cm mL kPa kg mL kPa cm mL kg mL cm 9 1 1 0 0 83 0 09 11 5 1 3 1 05 0 12 15 6 3 5 1 43 0 32 9 1 1 0 0 92 0 09 11 5 1 3 1 17 0 14 16 3 3 2 1 67 0 33 9 1 1 0 1 08 0 11 11 6 1 4 1 38 0 17 17 0 3 0 2 03 0 35 9 5 1 1 1 25 0 15 12 3 1 6 1 64 0 22 17 9 2 8 2 40 0 37 10 1 1 4 1 45 0 2 13 8 2 0 2 98 0 29 19 4 2 8 2 78 0 39 Data are expressed as mean SD Note with the exception of tidal volume and compliance during the first 6 months of postnatal life none of these ratios are constant therefore even in appropriately grown infants this would lead to significant misinterpretation if the average ratio for each outcome were adopted for use as a reference or normal value during the first 2 years of life from Nguyen et al 2013 141 6 3 Analysis and reporting of passive respiratory mechanics data e As mentioned in section 3 4 4 only data collected using the single occlusion technique will be discussed e Data may be identified and retrieved for review and analysis as described in section 6 1 2 e Ensure data were collected during periods of quiet sleep and no leak was evident 6 3 1 Main outcomes total respiratory compliance Cx
90. compared to results from other studies If you decide to withdraw your child from the study you have the option of withdrawing all data relating to your child and have any samples destroyed An exception to this is in the case of an adverse event where data needs to be retained for regulatory reporting However all data that is collected will be beneficial to the research study If you wish to and give us permission we are happy to inform your Family Doctor about the results of the allergy and lung function test How will your privacy be protected Any information you provide to us will be confidential Only the research team will have access to your child s information We will allocate all children a study code so that they are not easily identifiable Samples will be stored with a unique laboratory number and only be accessible to authorised staff working on the project Details that identify you or your child will be removed when the study is complete This information will be accessed used and stored in accordance with Commonwealth Privacy Laws and the NSW Health Records and Information Privacy Act 2002 What if you have a complaint about this study This research has been reviewed and approved by the Hunter New England Human Research Ethics Committee HNEHREC and this study has the reference number 09 07 15 5 04 Should you have concerns about your rights as a participant in a research study or you have a complaint abou
91. creen display shows an invalid FRC trial from a 1 year old infant 156 FRC data with evidence of glottic activity and possible mask leak 06 157 Menu for setting FRC regression SlOpe cccceseessssscecececessesseaeeeeeessessesssaeeeeess 158 Construction of the regression slope using 80 of each plotted FRC breath 159 Glottic activity observed during the 3 respiratory cycle represented in green while FRC data were recorded ccccseesscceessseececsenaececseaeeecseaeceeseaeeeeseaeeseneaas 159 FRC results when the Regression analysis for FRC was adjusted to exclude the upper anrd Tower IB heare ea EEEE e SEE AA ONE 160 Additional technically satisfactory FRC data to support values for reporting 161 Screen display of tidal squeeze data eccecsesscecececessessaeeeeeeseessesssaeseeeesensees 163 An example of a technically acceptable tidal RTC CUFVeE sssssnssesesesenssssssrresee 164 Tidal RTC curve evidence of flow limitation sssssssssesssssessssssrrsssrrressserrssres 165 Examples of partial FEFV curves that are Unacceptable ccccccccsssssssteeeees 166 Example of distortion due to severe glottic narrowing or closure ccccees 166 Effect of mild moderate glottic activity on tidal RTC CUrV eeeceessteeeeees 166 An example of delayed attainment of PEF due to a late rise time 0 167 An unacceptable jacket pressure transmission check c c
92. d if the patient is connected to it Please disconnect shutter from the patient During the shutter balloon test the compressed air balloon of the shutter is checked for air tightness T 15 ms T 30 ms T 45 ms Occ 1 P1 999 mBar P2 999 mBar P3 999 mBar Oce 2 P1 1042 P2 1042 P3 1042 o SO Figure 65 Shutter balloon test program Legend Left Click on Start button to activate shutter balloon test Right Satisfactory balloon test with stable balloon inflation pressure being sustained during test procedure 92 V 1 June 2014 i Figure 66 Visual check shutter balloon inflation Legend Left Shutter with latex balloon connected to PNT Right Activating the shutter balloon test results in inflation of the balloon effecting a brief airway occlusion during testing e The test results are acceptable if the balloon inflation pressure is stable over 45 milli second and over two trials Figure 65 e It is useful to visually observe the balloon inflation during the test procedure to ensure full inflation of the balloon Figure 66 If the balloon shows irregular bulging indicating a weakness replace the complete shutter as it is likely to rupture during data recording and disrupt the test session e If the balloon test is not acceptable at the initial trial Figure 67 check the fit of the tubing between the shutter and Control panel to exclude possible leak and or replace the
93. d and he she is awake and stable as assessed by a trained personnel Paediatrician Research Fellow Nurse Physiologist according to local policy the infant is discharged home with parents Parents are reminded to be diligent in observing and caring for their infant once leaving the Lab and for the remainder of the day of the test since he she may remain drowsy for several hours and their movements uncoordinated wobbly when crawling or walking A post test information sheet is given to the parents containing gt advice reminder to parents regarding management of infant post sedation gt name of sedation administered gt contact details of Lab personnel gt anthropometric measurements useful for other care givers 5 8 1 Post test phone call to parents If attended as an out patient a phone call is made to the parents within 24 hours to check on the wellbeing of the infant and answer any further questions parents may have 5 8 2 Hygiene infection control cleaning and disinfecting equipment General hygiene and disinfecting cleaning of equipment and linen should conform to policies of local institution The following sections are guidelines 132 5 8 2 1 Hand hygiene e Hand hygiene is the single most important way of reducing cross infection and should be carried out using liquid soap before and after patient contact e Alcohol gel is widely available as an alternative to hand washing to reduce bacterial load on
94. d previously his her record can be retrieved by entering either the name or a known specific number allocated to the infant e g hospital number or study number Amend and enter updated weight and length measurements and any other relevant information e g name of user investigator Click on F10 to save and exit Figure 44 75 V 1 June 2014 Patient 5 04c Dummy Dummy Last Name 1 First Name 04 09 2013 16 39P Identification Date of Birth 3B Months Sex Height wl Weight Diagnosis Patient History Smoker Figure 44 An example of an existing patient file being retrieved Legend Notice the 2 sheet with the heading Test Directory shown by the red rectangle indicating test data had previously been collected and stored e In order to proceed with the Calibration process it is necessary to type in the infant s current weight and length if these are not available prior to calibrating the equipment estimated anthropometric values may be entered However it is vital that the estimated values are corrected as soon as the infant has been weighed and length measured before analysis of lung function data as each epoch of lung function data will be saved with weight and length measurements entered prior to testing e To edit or update the weight length values click on Test Directory page or F3 to view the list of lung function data that had been saved to the database Figure 44 e S
95. d the air within e f necessary click on F8 icon to adjust or reset zero flow Figure 54 82 V 1 June 2014 1 001 0 996 0 151 Discard strokes B 0 081 Valid strokes 6 4 0 100 F Three flow protocol Calibration pump Type of display Pump volume L 0 100 E J Show FV soph r Vome Mz fy Scan pump size Flow Bs f ied a FAV tatio 1 1 21 Figure 55 Settings menu offering options for pump strokes Click on Settings from the menu bar Figure 55 notice that the choices of 3 and 6 have been selected for Discarded strokes and Valid strokes respectively Ensure that the correct volume 0 1 L has been selected for the calibration pump syringe Click on OK to accept the setting 83 V 1 June 2014 Click on F1 and start the volume calibration by delivering regular pump strokes 30 per minute backwards and forwards ensuring that each stroke is complete to the full 100 mL volume i e from impact to impact see Figure 56 Figure 56 shows the screen display of the initial 3 pairs of pump strokes representing inspiratory and expiratory respiratory efforts which will be discarded according to the default option in Settings Figure 55 DDCALVOL V4 52c x Program ump sr kes 100m 1 QYPE ea MAME O ase RA OVD Yy u nut mteteeAqQW VLA VOO sid WMV LLL I LT IIA is AOOO OOOO gk A Z 100 0 081 Bex Bin eer Figure 56 Screen display of the initial 3 pairs of
96. dence of a leak around the face MaSK cccccsseccceessececsesneeeceeceeeeeeaeeeeeeaas 109 Window A illustrates marked volume drift due to leak around the face mask 110 Time based tidal breathing trace after drift correction upper left window 111 Program option for saving tidal breathing measurement cccccecessssstteeeeees 112 An example of data from an infant in whom flow limitation is evident during tidal breathihE orent BRC oe ee ee Oe eee 112 A young child undergoing FRCpieth ASSESSMENT oo eee cece sees teesceteeneeneneees 114 A drop down panel listing different mask sizes and corresponding dead space115 Recording of plethysmographic airway resistance cccccssssececeeesessessaeeeeees 116 The screen shows a stable box volume signal and regular tidal breathing prior to the onset of an airway occlusion for FRC MeaSUreMeNts cceseesesseceeeeeeeeees 117 An infant undergoing tidal RTC ManO UVIe c cccccccsssssssssseeeceeessesssteseeeesensens 118 Screen display for tidal RTC cccsssscccccecsssessneececceecesseseeaeeeeeeseessesseaeeeeseseesees 119 Schematic diagram showing the inflatable bladder securely held in place by the outer jacket connected to the pressure reservoir tank by a large bore tubing 120 Position of the large bore tubing and connection to the RTC jacket 121 Menu for setting the reservoir pressure at the start of each tidal RTC trial 121 Display of V ma
97. e intercept Vic information regarding the time constant t pressure plateau P1 are quality control criteria used to evaluate the acceptability of the single occlusion flow volume curve 3 4 7 Plethysmography program settings Previously in section 2 5 it has been mentioned that currently it is not recommended for sReg data to be reported due to inadequate validation Further clarification is required regarding the impact of the application of electronic thermo compensation on the recorded sRaw data from infants 3 4 7 1 Sampling frequency for FRCpieth e To view or edit the setting of sampling frequency go to the menu bar click on Program gt Modify settings return to the menu bar click on Settings gt Common Figure 28 e Select the option for 100 Hz and click on OK to confirm Figure 28 62 V 1 June 2014 Note a sampling speed of 200 Hz is recommended when measuring infants young children with a rapid respiratory rate or if the user intends to collect sR data for future validation E Settings Common Data sampling Recording frequency Maximal length of recording per 5 45 min Figure 28 Selecting the sampling frequency for airway resistance and FRCpietn data collection 3 4 7 2 Setting criteria for the FRCpie n occlusion It is vital to set up the appropriate criteria for the duration of balloon inflation go to menu bar click on Program gt Modify settings return
98. e Destination data base is correctly selected this can be a folder in C drive or your USB pen where you want the data to be transferred to 3 you need to create a new folder or individual folders for separate sets of data e g label each folder with baby ID number 5 If you wish to export an individual set of data then use this function by entering the Baby ID number no need to enter date in this case 6 repeat this process in order to merge out different datasets also see note 3 above Merging data with an existing Lab4 database The procedure for merging data with a Lab4 database is similar to merging data out with the exception that in this instance the Destination data base will be C Lab4 DB and the Source data base would be in a drive connect with a USB pen or portable hard drive 219 Caution If there are stored data in the Destination data base i e C Lab4 DB DO NOT click on Create data base since this action will delete the existing database and create a new database into which the data from the external drive will be merged in CareFusion Export program The Export function enables a the lung function data to be extracted from C Lab4 DB in numerical format b the exported data to be viewed either as a text file using WordPad or worksheet using Excel program c periodic audit e g success or failure rate of a certain test or transfer of results to a log sheet or cus
99. e presence of an elevated airway resistance and a long Trs and gas trapping due to peripheral airway closure result in elevated FRC values in wheezy infants and those with diseases such as CF The principles of plethysmography which assesses total thoracic gas volume including any gas trapped behind closed airways are identical for infants and older subjects Infants are not able to cooperate in the special breathing manoeuvres required to reach either residual volume RV or total lung capacity TLC and although attempts have been made to obtain such measures by combining the raised volume technique with body plethysmography these are not in common use Assessments of plethysmographic lung volume FRCpieth in infants Figure 7 Figure 78 have been widely used in both clinical and epidemiologic research Balloon shutter Heated pneumotachometer tidal flow amp volume pressure at airway opening AVB Control panel Controlled mechanical leak in Reference chamber Figure 7 Schematic diagram of infant plethysmography Legend measurements of plethysmographic functional residual capacity are made while the infant sleeps within the plethysmograph and makes respiratory efforts against a closed shutter Plethysmographic assessments of FRC are based on Boyle s law which states that for any given mass of gas at a fixed temperature the product of pressure and volume remains constant i e Pa x Vi P x V w
100. e test will be performed on J2 Day Stay ward and takes approximately two hours Once your child is fully awake again and has tolerated feeding you will be discharged Lung function testing is not painful and not distressing We will contact you next day by phone for a follow up and then will discuss the test results with you 5 Nasal brushing While your child is sleeping we will collect some cells from the nose by using a soft brush These airway cells can be cultured and we can thereby measure the level of immune activation that is present in the airways of your child 4 Answering a questionnaire Questions e g about your child s and family s medical be asked 5 Documenting symptoms in a calendar We will provide you with a calendar and ask you to document all illnesses vaccinations and medications that your child experiences receives Are there risks amp benefits of participating The research team pays for all the tests and assessments that your child has Experienced staff with special training will collect samples and perform the lung function test The test will take approximately two hours and will be conducted by a Respiratory Paediatrician and another trained person In order to help your child sleeping during lung function testing we will give chloral hydrate orally 30min before the test Chloral hydrate is safe and side effects are observed very seldom in otherwise healthy infants Side effects can include un
101. e available in the Appendix section 8 3 Figure 78 A young child undergoing FRCpieth assessment 5 4 2 Selecting mask dead space for FRCpietn measurements e Double click on Bodyplethysmography to open program Figure 18 e A drop down menu appears allowing the investigator to select the correct mask size and dead space intended for use during data collection Figure 79 The effective dead space i e 50 of total mask dead space will be subtracted when calculating FRC values section 7 3 e Click OK to exit 114 V 1 June 2014 BabyBody 4 67a Dummy Dummy 10001 60 04 09 Program Settings Measuring system BabyBody 5 Shutter balloon test Medication Rendel Baker 0 Rendel Baker 1 The mask volume is the complete volume of the mask without the fittings For the calculation of the total deadspace 50 of this mask volume will be used VIASYS Healthcare GmbH 1992 2004 ar oz 0 12 Figure 79 A drop down panel listing different mask sizes and corresponding dead space 5 4 3 To start airway resistance recording e Click on F1 Start of watch to display flow signal in the top Monitor Safety panel NOTE Unless the mask and PNT have been moved or re positioned there is no need to re set zero baseline for flow volume via F8 icon e Click on F2 Start resistance measurements to begin recording e The screen display allows the user to observe the box volume signal which graduall
102. e calculated as the ratio of the change of calibration checks reference or calibration volume 100mL measured between different runs within same inspired or measured expired volume respectively occasion therefore minimum 2 runs DDCAL VOL V4 52c Old New 0ld 1 001 1 000 99 85 0 996 0 991 93 59 0 151 0 138 91 27 0 081 0 213 261 1 0 100 0 100 100 0 3 Syve caite ation E Figure 57 Acceptable volume calibration of the PNT Legend Six pairs of complete and regular 100 mL pump strokes were delivered To assess the quality of the calibration the user should concentrate on the display shown under New CorrIN is calculated as the ratio of the reference calibration volume i e 1OOmL measured inspired volume and CorrEX as the ratio of the reference volume measured expired volume In this example no correction is required for inspiratory volumes but the measured expired volume is fractionally higher than 100mL and is thus adjusted by multiplying by 0 991 With repeated calibrations within the same occasion the user should aim to achieve Old change from the previous calibration for CorrlIN and CorrEX to read between 99 and 101 i e within 1 of the reference volume 100 mL The repeatability of the calibration process is assessed from Q IN and Q EX which represent the coefficient of variation calculated from the Mean SD x100 of the 6 calibration stroke volumes during inspiration and expiration r
103. e data electronically to their own specific or customised database facilitating secure storage of lung function data with other relevant details such as background and clinical history 6 being able to transfer data electronically between databases or Excel worksheets eliminates the potential risk of typographic errors and greatly reduces the time that would have required to undertake data entry manually 183 NOTE For more information and furher details regarding the Merge function please see Appendix section 8 10 184 7 Recommended Reading List key papers 7 1 Background reading and review articles Rosenfeld M Allen J Arets BH et al An official American Thoracic Society workshop report optimal lung function tests for monitoring cystic fibrosis bronchopulmonary dysplasia and recurrent wheezing in children less than 6 years of age Ann Am Thorac Soc 2013 10 2 S1 11 Stocks J Hislop AA Sonnappa S Early lung development lifelong effect on respiratory health and disease Lancet Respir Med 2013 Stocks J Lum S Pulmonary function tests in infants and preschool children In Wilmott RW Boat TF Bush A et al eds Kendig s disorders of the respiratory tract in children Philadelphia P A USA Elsevier 2012 169 210 Stocks J Thia L Sonnappa S Evaluation and use of childhood lung function tests in cystic fibrosis Curr Opin Pulm Med 2012 18 602 608 Narang l Bush A Early origins of chronic obs
104. e duration of testing in order to avoid condensation since any moisture in the sensor would distort signals collected If the squeeze or forced expiratory manoeuvres are to be undertaken the PNT should have a linear range appropriate for the high flows observed during such manoeuvres and age weight of the infant Table 2 All surfaces and components must be easily decontaminated or cleaned with appropriate instructions provided by the manufacturer Appendix section 8 2 or according to local hospital guidelines section 5 8 2 2 Table 2 Range of flows in infants during tidal breathing and forced expiratory manoeuvres Flow range mL s Infant weight kg Tidal breathing Tidal RTC Raised volume RTC lt 2 0 100 0 200 0 500 2 4 0 200 0 500 0 1000 4 10 0 300 0 1000 0 3000 10 15 0 400 0 1500 0 3000 3 3 1 2 The Masterscreen BabyBody Plethysmograph e The commercially available Masterscreen BabyBody Plethysmograph v4 5 v4 67a Figure 12 see Appendix for supplier section 8 1 was developed and introduced following recommendations from the ATS ERS task force on infant LFTs section 7 3 e When closed the plethysmograph allows clear vision and easy access to the infant e During calibration and data collection it is not advisable to use include the following objects within the plethysmograph 52 V 1 June 2014 airconditioning or a fan compressible and fluffy objects e g cellular blanket a
105. e infant s respiratory cycles initiate lung inflation at the start of tidal inspiration until volume signal crosses zero flow release the inflation to allow passive expiration A Figure 90 RVRTC apparatus se up for RVRTC manoeuvres Legend The photo shows the Neopuff resuscitator left connected to the T piece and straight connector which are inserted to the PNT to enable intermittent delivery of 3 5 augmented breaths at a positive inflation pressure of 30 cmH 0 to raise or extend lung volume towards total lung capacity prior to forced expiratory manoeuvre Intermittent inflations and subsequent emptying of the lungs are achieved by repeated occlusions of the Neopuff T piece opening see Figure 90 using the thumb at a rate approximating the infant s respiratory frequency i e if inflation is held for 1 second and expiration takes 1 second this corresponds to a rate of 30 breaths minute whilst a 2 second occlusion would equate to 15 breaths minute While augmenting the lung volume towards total lung capacity TLC observe the time based flow volume signals in the upper left window hold each inflation until volume and Po signals reach a plateau denoting maximal inflation to pre set PIP before releasing the 127 occlusion at the T piece opening to allow spontaneous passive expiration to FRC Figure 91 Allow full exhalation of each passive expiration before repeating the next inflation in order to avoid
106. e several important procedures to ensure that each of the Masterscreen system programs are suitably customised e g e set review the sampling speed e set review criteria for airway occlusion and data collection e set review the content list of lung function results and quality control features for display on screen Failure to do this may invalidate all subsequent data collection 3 4 3 Tidal breathing program settings 3 4 3 1 Sampling frequency for tidal breathing e Open the program by double clicking on Tidal Breathing Analysis Figure 18 e Tocheck set the sampling frequency from the menu bar click on Program gt Modify settings 55 V 1 June 2014 back to the menu bar click on Settings gt modify gt Evaluation and Display Figure 20 Select the option for 100 Hz Figure 21 Tidal 4 60 4 0 Dummy Dummy New test Program IESS Measuring system BabyBody S Medication Menu bar 4 Number of breaths in on line evaluation Number of highest and lowest values to delete I Start flow volume loop at zero during online display I Start flow volume loop at zero during result display IV Show volume time curve during result display Sampling frequency of data acquisition _ Maximum length of data acquisition 5 33 min 8 8 8 8 8 amp 8 amp 8 B Please start measurement by pressing space bar Figure 21 The setting of sampling frequency for tidal breat
107. e shape of the expiratory curve was no longer convex but becoming concave suggesting flow limitation had been achieved 6 5 4 Examples of invalid trials Some examples of technically unsatisfactory partial forced expiratory flow volume curves are shown in Figure 131 see legend for description The two examples in Figure 132 and Figure 133 show forced expiratory flows that were interrupted by glottic activity In Figure 132 left panel severe glottic activity during the 12 trial Act 2 red square in the right panel distorted the FEFV curve with V maxerc being 19 lower than that for Act 1 11 trial blue square right panel which was obtained at the same P central panel and also lower than 3 of the previous curves trials 6 8 and 10 all represented by grey squares right panel obtained at lower P In this example Act 2 should be de selected and excluded from final calculation 165 40 o 40 Volume mL C 40 0 Volume mL Figure 131 Examples of partial FEFV curves that are unacceptable Legend This composite illustration shows A early inspiratory effort during the forced expiratory phase such that there is no flow at FRC flow distortion due to narrowing or closure of the glottis or larynx during the early B mid C or late D portion of forced expiration Best Actl Act2 Act3 m Vina FRC mi s Tinia Figure 133 Effect of mild moderate glottic activity on tidal RTC curve Legend
108. e shutter Open shutter after a max occlusion time of V additional open conditions or after max of efforts _ C or at a pressure sum of and 1 effort Number of breaths post occlusion Deadspace Pure apparative deadspace 4 30 mi Mask deadspace Rendel Baker 2 20 0 mL 10 00 ml Additional deadspace o0 E m Total deadspace 14 30 mi Regression analysis for FRC Excluded portion of slope Pao fio Figure 29 Recommended settings for FRC occlusion Legend Note the additional open conditions for terminating the airway occlusion 3 4 7 3 Contents of FRCpien result table In order to review or edit the list of variables displayed in the result table top right hand window Figure 28 e Go to menu bar click on Program and Modify settings return to the menu bar click on Settings gt modify gt Parameter list gt Contents of Table e Browse through the list of variables and select relevant ones for display Figure 30 e Click on the Accept button to save contents and OK to exit 64 V 1 June 2014 Tie cate Contents of table Properes Column Selected ve H Fies 277 Acti Act2 Act3 Acta afc aj Formulas _Pred FRCpcv Afi B EELs _Best _PredLL _PredUL zaai E Prea zaal Eac E WV Auto text V Long form Figure 30 Selected FRCpiethn variables for display in the result window Once the plethysmograph has been calibrated airway resistance and FRC measur
109. e sufficiently long enough to fully complete forced expiration forced expiration should be a smooth curve and continue beyond FRC jacket transmission pressure should be gt 2 kPa except in infants with marked airway obstruction in whom flow limitation may be established at lower pressures Data evaluation While data collection is in progress the online analysis calculates and displays the 3 best partial forced expiratory flow volume PEFV curves in colour with the best V maxerc shown both as the highest and the mean value in the results table Figure 128 Other PEFV curves with lower V maxrrc are automatically de selected shown in grey and PEFV curves that did not meet the quality control criteria are indicated as blank symbols in the trend window Figure 128 However it should be noted that the 3 curves automatically selected by the program software as the best due to the numeric value of V max are not necessarily technically acceptable It is therefore essential to review and or modify the analysis off line It is possible to re select and re evaluate any of the PEFV curves that are valid but shown in grey since these are not one of the top 3 manoeuvres with the highest V maxerc in the trend 162 window However since a maximum of 3 curves can be displayed at any one time one or more of the curves shown in colour must first be de selected click on either the circle or square symbo
110. e throughout the first two year of life which has allowed widespread assessment of passive respiratory mechanics in infants and young children Although significant changes in R have been reported among infants with airway disease the major role of these measurements is probably with respect to assessing compliance in conditions in which there is likely to be restrictive pulmonary changes e g respiratory distress syndrome broncho pulmonary dysplasia pulmonary hypoplasia and cardiac disease with pulmonary over perfusion The occlusion technique for measuring passive respiratory mechanics is based on the ability to invoke the HBR by performing brief intermittent airway occlusions during spontaneous tidal breathing Activation of vagally mediated pulmonary stretch receptors when the airway is occluded above FRC leads to inhibition of inspiration and prolongation of expiratory time Figure 4 32 V 1 June 2014 end inspiratory airway occlusion pressure plateau Pao D Time s t 16 62 18 82 6 Figure 4 An airway occlusion at end inspiration in infants invokes the Hering Breuer reflex resulting in inhibition of inspiration and prolongation of expiratory time Legend t expiratory time during tidal breathing te occ expiratory time during an occluded breath Provided there is no respiratory muscle activity and rapid equilibration of pressures across the respiratory system during airway occlusion as shown by the pres
111. e to reach peak tidal expiratory flow as a ratio of total expiratory time C and R compliance and resistance of the respiratory system respectively FRCpern plethysmographic functional residual capacity Legend tpter te and R are expressed as log transformed therefore to calculate Z scores for tprer te and R the measured values should be natural log transformed before subtracting the predicted values divided by the RSD using values presented above 181 Table 6a Adjusted prediction equations for RVRTC outcomes taking length into account Lum et al 2010 Adjusted zFVC ZFVCijones 0 057 x length cm 3 90 Adjusted zFEV 5 ZFEVo stiones 0 058 x length cm 3 83 Adjusted zFEF7 ZFEF75 ones 0 037 x length cm 1 94 Adjusted ZFEF 35 75 ZFEF 25 75 ones 0 040 x length cm 1 94 Adjusted V maxerc ZV maxFRC Hoo 0 074 x length cm 4 17 Table 6b Adjusted prediction equations for RVRTC outcomes taking age into account Lum et al 2010 Adjusted zFVC ZFVCiones 0 018 age weeks 0 538 Adjusted zFEV 5 ZFEVostiones 0 018 age weeks 0 341 Adjusted zFEF7 ZFEF75 ones 0 010 age weeks 0 347 Adjusted ZFEF 35 75 ZFEF 25 75 ones 0 011 age weeks 0 491 Adjusted V maxerc ZV maxFRC Hoo 0 020 age weeks 0 355 Abbreviation z Z score Legend As published reference data for RVRTC Jones et al AJRCCM 2000 were inap
112. ean of two measurements which are within 0 5 cm of each other Note Accuracy of the stadiometer should be checked weekly using metal rods measuring 40 60 and 80 cm in lengths respectively 4 3 2 3 3 Head circumference This measurement should be obtained with a device that is non stretchable e g a disposable paper tape or tailor s measuring tape From the most prominent part of the forehead often 1 2 fingers above the eyebrow wrap the tape snugly around to the widest part of the back of the head Aim to measure the widest circumference around the head Measure the head circumference at least twice and record the largest head circumference measurement to 1 decimal place in cm 4 3 3 Records and documentation As per the local policy and Data Protection Act all records and documentation should be labelled a specific test hospital number should be allocated to each subject and stored appropriately Electronic media containing patient data should be treated similarly The length of time such records and documentation needs to be stored will depend on local policy e g for 18 25 years 4 3 3 1 Questionnaire relevant to lung function tests Examples of these questionnaires are presented in Appendix sections 8 6 and 8 7 Briefly information documented should include Background information infant and family Gestational age Birth weight and length z score and or centile Clinical diagnosis e g cystic fib
113. echtl HF The behavioural states of the newborn infant a review Brain Res 1974 76 2 185 212 185 7 3 Equipment Specifications and signal processing Frey U Reinmann B Stocks J The infant lung function model a mechanical analogue to test infant lung function equipment Eur Respir J 2001 17 4 755 764 Reinmann B Stocks J Frey U Assessment of an infant whole body plethysmograph using an infant lung function model Eur Respir J 2001 17 4 765 772 Frey U Stocks J Sly P et al Specification for signal processing and data handling used for infant pulmonary function testing ERS ATS Task Force on Standards for Infant Respiratory Function Testing Eur Respir J 2000 16 5 1016 1022 Frey U Stocks J Coates A et al Specifications for equipment used for infant pulmonary function testing ERS ATS Task Force on Standards for Infant Respiratory Function Testing Eur Respir J 2000 16 4 731 740 7 4 Methodological papers relating to infant LF tests 7 4 1 Tidal breathing Bates J Schmalisch G Filbrun D et a Tidal breath analysis for infant pulmonary function testing Eur Respir J 2000 16 1180 1192 7 4 2 Passive Respiratory Mechanics Hoo AF Lum S Goetz I et al Influence of jacket placement on respiratory compliance during raised lung volume measurements in infants Pediatr Pulmonol 2001 31 51 58 Gappa M Colin AA Goetz et al Passive respiratory mechanics The occlusion techniques Eur Respir J 2001 17 141 148
114. ection will stop automatically when 2 5 breaths have been recorded after release of airway occlusion Click on F7 Display results briefly review quality of flow volume curve and results If results are satisfactory click on F10 Save data and exit program otherwise Click on F9 New start of complete measurement follow instruction on the screen when prompted Save measurement A new test or trial will commence once the operator has clicked on Yes or No button Continue recording until sufficient data have been collected click on F10 to save and exit program Mean results from 3 technically satisfactory SO trials are reported 5 4 Measurements of plethysmographic lung volume FRCpietn The infant FRCpiein program allows simultaneous recording of specific airway resistance SRaw and FRCpietn during each trial or Act As in older subjects measurements of FRC jth and airway resistance Raw can only be recorded while the plethysmograph is closed 113 V 1 June 2014 5 4 1 Prior to FRCpien recording A brief period of 2 3 minutes is required to allow the interior ambience of the plethysmograph to stabilise and reach thermal equilibration before data recording commences e The process of setting or reviewing the sample frequency and contents of result table has been described in sections 3 4 7 1 and 3 4 7 3 e Check that all program settings are correct section 3 4 7 2 e Alist of Function keys ar
115. ee 187 Recent applications of infant LF tests in clinical research using CareFusion BabyBody Masterscreen CQuiPpMe Nt misonerien ioiaren ia arisia naeia aiea dinni iieii 188 Applications in clinical research using other ILFT equipment ccceeseesesteeeeeeees 189 Assessment of bronchodilator responsiveness USING ILFTS c cccccccesssssstseeeeeeens 190 Examples of epidemiological research applications cc cccccccccsssssssssceeecesessesssaeees 190 Revie WS tn a a a a tales sell sdagagavacatanendececpenedguncedetacauvataagutysdentels 190 Wheezenminiicooi otie aE e E E URA n a a ete 190 Pr etermdeli v r yanna aaea aaa antaa aA a Aaa aaa Raai 190 Prospective cohort studies ClaSSIC cccccccsesccceessscececsssaeeecseseeeceesseeeeeensaes 191 RECENE CONOLE StUdie Sissi tanvsiserdennyns sei Ukundss AKENTA eaa ak 191 Appendice Senaren asea Nen AENEAN ARENA IAS AANE ANANA 193 List Of MAaNUfACtUlers cc cecccscieeiscctes cavesdutssedeesecassviadsscerysccadsavadosedevi vaauderatosntevesctdeeess 193 CareFusion s guidelines for Sterilisation and Disinfection ccccccssessssceeeeeseesees 194 Masterscreen system Function icons Keys c cccsssssssesesesesesescscscscscscscscsvscecsceeseaees 195 An example of parental information leaflet cccccssccccecessesssseceeeeecessesssneaeeeeeens 196 Example of a Consent form for a research study cccsessceceeecessesseaeeeeeeesessesseaeees 198 Questio
116. een changes in Pao and changes in Vg measured during airway occlusion for the 3 inspiratory and expiratory efforts that the infant made against the closed shutter The three FRC measurements denoted as FRC O blue FRC 1 red and FRC 2 green in window D for this trial are reproducible and a mean of 160 7 mL is reported window C Note On occasions the last inspiratory expiratory effort may be incomplete due to end of airway occlusion after 10s can lead to distortion and may need to be excluded Occasionally a lower EEL may be observed following the release of airway occlusion when compared with that established prior to onset of the occlusion Figure 119 see details in figure legend 153 Best Actl Act2 Act3 Act4 F Voha i N N A Ni ea WANA WW WN Figure 119 EEL was observed to be lower r following 1 the release of airway occlusion when compared to that established prior to onset of occlusion Legend The difference in EEL pre and post occlusion can be seen in Window B d EEL 9 window C In infants the resting lung volume is dynamically modulated e g spontaneious PEEP to raise lung volume according to the individual s immediate needs During airway occlusion the sustained distension of the lungs stimulates the pulmonary stretch receptors which mediate the Hering Breuer inflation reflex temporarily reducing the frequency of respiratory rate and increasing relaxation of the resp
117. eer sven atncstecdevesa cveiteceedsedsandratindedesVovusudtiitecteddetssadcatneedestes 53 Preparation prior to performing equipment Calibration cccsssscccecessesssteeeeeeeens 55 Displaying quality control Criteria cece ssessssececeeeeessessneeeceesesseesssteaeeeeees 55 Setting up essential criteria for test PrOSraMS cccccscccceceesssessssseeeeeeeseeeees 55 Tidal breathing program settings cccccccccssssssssececeeecsssesseeeeeeesesssesssssaeeeeees 55 Sampling frequency for tidal breathing ccccccssssscecccsesssessaeeeeecesessesseaeeeeeesseesees 55 Setting technical criteria for tidal breathing ccccccccccsssssssssseeeeecesseseetaeeeeeesseesees 57 Contents of tidal breathing result table cecccsssseccceceeessesseaeeeeeceseesesnsaeeeeeeeseesees 58 Passive respiratory mechanics Crs and R s program SettiNgS cccceceeeeee 59 Sampling frequency for passive respiratory MEChHANICS ccccccccccesesssssseeeeeeseeesees 59 Setting technical criteria for single occlusion test SOT cccsccccsssceesteeesees 60 Contents of passive mechanics result table cccesesscececeeeseesssseseeeeeeseeeees 61 Plethysmography program SettingS ccccccccsssssscececeesssessnseeeceeeesseesssssseeeeees 62 Sampling frequency for FR Clerisie tinest taises iii aiaei ie ii aatia iiia 62 Setting criteria for the FRCpieth OCCIUSION ns nsnssnsssensssesiseesesnsenrisensnnearinrnsenrenesasen
118. ef 1 s occlusion used for test occlusion or SO technique Ideally d EEL should be lt 10 12 repeat FRC collection so that results from different trials with varying dEEL may be compared Occasionally dEEL of up to 20 is observed in the absence of any 151 apparent leak simply because it has not been possible to record sufficient breaths post occlusion Provided data supported by other trials such data may be acceptable If a mask leak is confirmed open the plethysmograph carefully without waking the infant adjust or reposition the mask PNT to eliminate mask leak before continuing with further FRC data collection Once the plethysmograph is closed while waiting for thermal equilibration to occur if necessary more tidal breathing or C R data may be recorded before proceeding to collect FRC data Flow occlusion Volume lt pressure plateau not sustained Figure 117 Indications of a leak around the face mask Legend These include a fall in Pao during occlusion and a persistent step up of volume baseline following occlusion when plotted graphically changes in Pao and changes in Vg vertical and horizontal axes respectively should be in phase i e the signals changing proportionally to form a diagonal slope with no looping Figure 118 window D each act or trial should comprise a minimum of 2 occluded breaths each breath comprising a full inspiratory and expiratory effort
119. elect highlight the appropriate line of data by inspecting data time and type of data saved Click on Info button Figure 45 e View data in the drop down Test Information panel Figure 46 Edit or update data as necessary click on Save and select Yes to accept or No to reject the modified data Figure 46 and Figure 47 76 V 1 June 2014 Patient V5 04c Dunwny Dumeny Figure 45 Test directory showing a list of data saved in the Masterscreen database The red circle indicates Info button Patient 5 04c Dummy Diuereny S7 04107 2312 112 S 046 1072012 113 Figure 46 Save button in the Test Information panel is highlighted by the red circle 77 V 1 June 2014 gt Figure 47 Screen option allowing the user to accept and save the modified data The red circle highlights the Exit button e Click on the X button circle in red Figure 47 to exit this page e To view the whole directory of data click on F8 which toggles between compressed mode and detailed mode e Click on F10 to exit Patient Data and return to the LabMan4 main interface Figure 18 3 4 10 2 List of Function keys associated with Patient data program F1 Current patient click on Function key 1 or tap Enter key twice to retrieve current or last patient s folder F2 Search patient click on Function key 2 to access Patient Directory F3 This button changes between the windows toggles b
120. elect relevant ones for display Figure 42 e Click on the Accept button to save contents and OK to exit RVRTC V4 67a Dummy Dummy 10001 New test Figure 42 Selected Raised Volume RTC variables for display in the result window 74 V 1 June 2014 3 4 10 CareFusion Masterscreen database Prior to calibrating the PNT and the plethysmograph Box it is advisable to create an electronic Patient record within the Masterscreen system database This helps to avoid the potential error of collecting and storing lung function data into a wrong Patient record file in the database 3 4 10 1 Creating a patient record double click on Patient Data icon Figure 18 to create or indeed to retrieve a patient record a If this is the infant s first test occasion a new folder or record can be created by entering his her details other relevant comments may also be added such as clinical diagnosis name of operator investigator and clinician performing the infant s clinical examination prior to testing Figure 43 Click on F10 to save and exit Last Name Lab Number First Name Last Test Identification Date of Birth Age Rel Weight BSA Race Caucasian Insurance Pred Module Standard Operator Ward Profession Diagnosis Patient History Physician Ref Physician Figure 43 LabManager V4 Main group Patient Data page b If the infant has been teste
121. ements are undertaken with the box closed Prior to lowering the hood a brief airway occlusion is made manually during tidal breathing to check that the mask seal is air tight Data collection is started by recording an epoch of tidal breathing until the box volume signal becomes stable then activating an airway occlusion by clicking on F3 to continue with collection of FRC data section 5 4 4 During data collection BTPS correction is applied to flow and hence volume signals A drift correction is also applied 3 4 8 Tidal RTC program settings e From the LabManager Main group screen open the program by double clicking on Tidal Squeeze icon Figure 18 3 4 8 1 Sampling frequency for tidal RTC This test is programmed to automatically data collect at the minimal acceptable sampling speed of 200 Hz 3 4 8 2 Setting measurement criteria for tidal RTC manoeuvres e Along the menu bar click on Program and select Modify settings e Return to the menu bar click on Settings gt Measurement Figure 31 and Figure 32 65 V 1 June 2014 Baby Tidal Squeeze V4 67a Dummy Dummy 10001 New test Progam EIEN Measuring system BabyGody S Shutter balloon test Medication none Menu bar NL Reservoir pressure 2 Py Trend view Axis scaling 5 HE Trigger settings F i Warnings Pressure transmission Parameter list Read Save as Data collection Minimum amp
122. ence of a pressure plateau at the airway opening Figure 4 alveolar pressure and hence elastic recoil of the respiratory system can be measured at the airway opening By relating this recoil pressure to the volume in the lungs above the passively determined end expiratory volume at time of airway occlusion or to the air flow occurring on release of the occlusion the compliance and resistance of the respiratory system can be measured The most commonly used approach for which commercially available equipment is available is the single breath or single occlusion SO technique Figure 105 When using this technique resistance compliance and the passive time constant of the respiratory system T can be calculated from a single airway occlusion Figure 104 Since the time constant volume flow Tys can simply be derived from the flow volume relationship during a passive expiration which frequently follows the release of a brief airway occlusion Compliance of the total respiratory system C is calculated by relating the volume above the passively determined elastic equilibrium volume EEV as determined by the equal and opposite recoil pressures of the lung and chest wall at the moment of airway occlusion to the elastic recoil pressure measured during occlusion Figure 6 and section 6 3 2 33 V 1 June 2014 Flow and volume Pneumotachometer Shutter Figure 5 Schematic diagram of equipment used for passive mec
123. ent practice Am J Respir Crit Care Med 2005 172 11 1463 1471 e LumS Hoo AF Stocks J Influence of jacket tightness and pressure on raised lung volume forced expiratory maneuvers in infants Pediatr Pulmonol 2002 34 361 368 e LumS Hoo AF Stocks J Effect of airway inflation pressure on forced expiratory maneuvers from raised lung volume in infants Pediatr Pulmonol 2002 33 130 134 e Hoo AF Lum SY Goetz et al Influence of jacket placement on respiratory compliance during raised lung volume measurements in infants Pediatr Pulmonol 2001 31 1 51 58 e Sly P Tepper R Henschen M et al Standards for infant respiratory function testing Tidal forced expirations Eur Respir J 2000 16 741 748 7 5 Interpretation of data and reference equations e Stocks J Kirkby J Lum S How to avoid misinterpreting lung function tests in children a few practical tips Paediatr Respir Rev 2014 http dx doi org 10 1016 j prrv 2014 02 001 Nguyen TT Hoo AF Lum S et a New reference equations to improve interpretation of infant lung function Pediatr Pulmonol 2013 48 4 370 380 e Stanojevic S Quanjer PH Miller RM et a The Global Lung Function Initiative dispelling some myths of lung function test interpretation Breathe 9 463 474 2013 Stanojevic S Wade A Stocks J Reference values for lung function past present and future Eur Respir J 2010 36 1 12 19 Lum S Hoo AF Hulskamp G et a Potential misinterpretation
124. ere with data collection for techniques such as the multiple breath inert gas washout Braking of expiratory flow Volume insp Fi End expiratory level Note fall in resting lung volume when expiratory time tz is prolonged followed by dynamic elevation when tz becomes shorter Figure 1 Dynamic elevation of lung volume 1 2 3 Influence of the upper airways Infants are preferential nose breathers with nasal resistance representing approximately 50 of total airway resistance Ray Changes in lower Raw as a result of disease or therapeutic interventions may therefore be masked especially if there has been a recent upper respiratory tract infection URTI Infant LFTs should therefore be postponed for at least 3 weeks after the onset of any respiratory infection Since the nose also acts as an efficient filter comparatively 24 V 1 June 2014 less aerosolised material whether delivered as a challenge or a therapeutic intervention may reach the lung than in a mouth breathing adult 1 3 Sleep state sedation and duration of the testing procedure A representative stable end expiratory level is essential for reproducible measures of FRC respiratory mechanics and maximum flow at FRC V maxerc and can normally only be achieved if the child is in quiet rather than rapid eye movement REM sleep Since the duration of quiet sleep epochs is inversely proportional to postmenstrual age PMA gestational postnatal a
125. es Who Has urine been collected Has saliva been collected 211 8 8 Lung function test summary sheet Completed on each test occasion GOS Hospital No Referring Consultant Dr Referring Hospital Child s name Referring Hospital number DOB Male Female Study no test Test date Weight kg Crown Heel length cm e Physical Examination Clinician name 0 cceeeeeee eee Signature c ceeeeeeeeee eres Wheeze O Yes C No Crackles Yes C No Was overall physical examination normal L Yes L No Comments Cough swab taken C Yes No Comments Sedation Chloral Hydrate 0 0 mg given orally rectally at 000000 hrs Any observed adverse effects from sedation No O Yes O Comments Pre sedation oxygen saturation RR bpm Heart rate bpm Post sedation oxygen saturation RR bpm Heart rate bpm On Completion of Lung Function Test a Is infant fully arousable responsive Yes O No J Comments b Taken a Feed Drink Yes J No J Comments Time of departure hrs Lung function tests performed by eeeeeeeeee eee es AEN A E EEATT Present at tests Yes No O parents relative Post test phone call made by Date amp Time Comments Page 1 of 1 212 8 9 An example of infant lung function report
126. es and data collected during the study may be looked at by individuals from regulatory authorities or from the NHS Trust where it is relevant to taking part in this research give permission for these individuals to have access to my child s records and to use relevant information in subsequent scientific publications in a way that ensures neither nor my child can be identified 4 agree to my GP being informed of my child s participation in the study 5 agree for my child to take part in the above study Rec No 09H071314 Version 1 dated 09 02 09 page 1 of 2 198 Early detection of lung disease in infants with CF diagnosed by newborn screening Name of Parent Guardian Signature Relationship to child Name of Person taking consent Signature When completed 1 copy for family 1 copy for researcher site file 1 original copy to be kept in medical notes NOTES FOR THE RESEARCHER It is your responsibility to ensure that the parents guardians and child if mature enough understand what the research project involves both theoretically and practically You must allow sufficient time to do this You must make the judgement of whether or not the child can understand the project Age alone is not important Make sure that the relatives or child can contact you if they have additional questions A copy of this completed form must be placed in the patient s clinical records and a copy must be kept b
127. es the Merge function icon ction A Othe setae Ue in Teal dt he bas Othe Teta ie ata NES Stay 183 17 V 1 June 2014 List of Tables Table 1 Table 2 Table 3 Table 4 Table 5 Table 6a Table 6b Summary of face mask dead space Range of flows in infants during tidal breathing and forced expiratory manoeuvres Dosage of sedation used for lung function tests Sleep state classification Equipment specific prediction equations Adjusted prediction equations for RVRTC outcomes taking length into account Adjusted prediction equations for RVRTC outcomes taking age into account 18 List of abbreviations symbols and conversion factors V 1 June 2014 Abbreviation Symbol Description Unit ATPS saturated with water vapour at ambient temperature and barometric pressure ATS American Thoracic Society BDR bronchodilator responsiveness bpm breaths per minute BPD broncho pulmonary dysplasia BTPS saturated with water vapour at body temperature 37 C and ambient barometric pressure C degree in Celsius cm centimetre cmH 0 centimetre of water Crs compliance of the total respiratory system mL kPa CV Coefficient of Variation CF Cystic Fibrosis EEL end expiratory level EEV elastic equilibrium volume mL ERS European Respiratory Society FEV forced expired volume measured at t seconds after mL exhalation has begun e g FEVo s FEFy forced expired flow measured after x of F
128. espectively If Q exceeds 1 0 the user will be prompted to repeat the calibration In practice provided complete and regular strokes are delivered much lower values of Q are recorded as shown above compare these values with those displayed during unsatisfactory calibration inFigure 58 Please note for these parameters expressing results as of OLD is not helpful since if prior 85 V 1 June 2014 calibration has been extremely repeatable e g in the above example Q EX is lt 0 08 then even the slightest increase in variability to 0 22 will lead to an apparent increase in the CoV to 261 Therefore users are advised to ignore data displayed in the Old column for the Q and CalVol parameters Note Any moisture or dust particle on the PNT resistive mesh screen and pressure ports will affect the quality of PNT calibration In addition methods use to clean disinfect the PNT screen may also change its properties e The user will be prompted by a drop down panel to repeat the calibration if incomplete and or irregular pump strokes have been delivered Figure 58 0 984 1 108 112 5 0 977 1 068 109 2 0 133 15 70 11834 0 117 15 89 13606 0 100 0 100 100 0 Figure 58 Unsatisfactory volume calibration Legend Note screen message instructing the user to repeat calibration due to incomplete pump strokes which are evident both from the histogram and the very high values for Q Summary e If Corr is greater than 2 b
129. ests 4 3 1 On the day before the tests The parents are contacted e to check that the infant is free from respiratory symptoms e to remind them of the fasting regime see above e to remind them that it would be helpful to try to keep the infant awake while travelling to the Lab 4 3 2 On arrival to the Lung Function Lab 4 3 2 1 Consent For clinical tests parental informed consent is obtained This is usually considered adequate although it varies according to the policy of local hospitals For research studies or when conducting tests that are deemed to have no direct benefit to the infant parents are formally requested to sign 3 copies of the consent form according to the recommendation of the Ethics Committee commonly one copy is given to the parents the 2 and 3 copies are each filed in the hospital medical notes and Lab records respectively Note Chloral hydrate sedation is only given after parental consent has been obtained Written parental consent is also essential for the collection and storage of biological samples e g urine sample for cotinine assay to determine exposure to tobacco smoke Regardless of whether collected during clinical or research testing if the lung function data are intended to be stored and used later for reporting in scientific journals or presented at conferences and meetings it is likely that ethics approval and written informed consent from parents will be required This is best obtai
130. etween Patient data and Test Directory F8 toggles between compressed mode and detailed mode F9 Save data entered program not exited F10 Save data entered and exit program 3 4 11 Preparation and calibration of the Babybody Masterscreen system Careful calibration of the equipment including safety checks is performed prior to each test session The Babybody Masterscreen system with apparatus such as the PNT having been 78 V 1 June 2014 inspected assembled and inserted into the sensor housing requires 20 minutes warming up time to ensure thermal equilibration is achieved 3 4 11 1 Assembling the PNT components and balloon shutter Before assembling the apparatus inspect and ensure that all the components are dry and in particular that the PNT resistive mesh screen is free of any dust or dirt particles It is advisable to handle the PNT screen only by its ridge Check that the PNT screen is correctly positioned between the PNT parts Once assembled the complete PNT is slotted in to the sensor i e pressure transducer housing Figure 48 a and b It is vital that the 2 pressure ports on the PNT are in direct contact with the pressure ports within the pressure transducer housing Figure 48b Note that the balloon shutter has a bevelled or sloped end insert this end to the PNT Figure 48c away from the patient side Figure 53 In addition check that the clear shutter tubing is firmly fitted to
131. exhales forcefully to RV is the most frequently used method for measuring airway function in older subjects By substituting voluntary effort with externally applied pressure to the chest and abdomen to force expiration it has been possible to adapt these measurements for sleeping infants 38 V 1 June 2014 2 6 1 Partial forced expiratory manoeuvres Tidal RTC Partial expiratory flow volume PEFV curves can be produced by wrapping a jacket around the infant s chest and abdomen and inflating this at the end of tidal inspiration to force expiration The resultant changes in air flow and hence volume are recorded through a PNT attached to a face mask through which the infant breathes Figure 9 Figure 82 Figure 84 This technique is referred to as the squeeze or tidal rapid thoraco abdominal compression RTC technique The maximal forced expired flow at FRC V maxerc Which is a measure of forced expired flows FEF at low lung volumes i e similar to FEF7 in older children is the most commonly reported parameter derived from this technique Figure 9 As detailed in the reading list section7 4 4 standardised guidelines regarding data collection and analysis for tidal RTC have been published as have sex specific collated reference data section 7 5 The tidal RTC technique has been used widely in clinical and epidemiological research studies with reductions in V maxrrc being identified in babies born to mothers who smo
132. f 16 Mother s ethnic origin White British White Irish Other White Black Caribbean Black African Black other White Black Caribbean White Black African White Asian Other mixed Pakistani Bangladeshi Indian Chinese Other Asian Other Father s ethnic origin White British White Irish Other White Black Caribbean Black African Black other White Black Caribbean White Black African White Asian Other mixed Pakistani Bangladeshi Indian Chinese Other Asian Other Number of siblings Number of older siblings Day care No Yes Nursery Yes Child Minder Age when started months Recruitment centre Referring LCFC Consultant Date of recruitment Date of referral GOSH Consultant Local Paediatrician Name Address Telephone no GP s name Practice address Practice tel no Paae 2 of 4 201 Subject No Hospital Number Subject ID NHS number Date Date of diagnosis Genotype Mutation one Mutation two if and when known Presentation Mode s of Presentation Sweat Test Repeat Result Sweat Test Result Asymptomatic Positive Positive Meconium ileus Negative Nega
133. f lung function in infants with bronchopulmonary dysplasia Pediatr Pulmonol 2011 46 4 369 375 Fakhoury KF Sellers C Smith EO et a Serial measurements of lung function in a cohort of young children with bronchopulmonary dysplasia Pediatrics 2010 125 6 e1441 1447 7 9 4 Prospective cohort studies classic Stern DA Morgan WJ Wright AL et a Poor airway function in early infancy and lung function by age 22 years a non selective longitudinal cohort study Lancet 2007 370 9589 758 764 Turner SW Palmer LJ Rye PJ et a The relationship between infant airway function childhood airway responsiveness and asthma Am J Respir Crit Care Med 2004 169 8 921 927 Martinez FD Morgan WJ Wright AL et al Diminished lung function as a predisposing factor for wheezing respiratory illness in infants N Engl J Med 1988 319 17 1112 1117 Haland G Carlsen KC Sandvik L et a Reduced lung function at birth and the risk of asthma at 10 years of age N Engl J Med 2006 355 16 1682 1689 Morgan WJ Stern DA Sherrill DL et al Outcome of asthma and wheezing in the first 6 years of life follow up through adolescence Am J Respir Crit Care Med 2005 172 10 1253 1258 7 9 5 Recent cohort studies Mullane D Turner SW Cox DW Goldblatt J Landau LI le Souef PN Reduced infant lung function active smoking and wheeze in 18 year old individuals JAMA Pediatrics 2013 167 4 368 73 van der Gugten AC Uiterwaal CS van Putte Katier N
134. f the T piece resuscitator tubing is inserted to a straight connector 15M 15M Figure 16 see Appendix for supplier section 8 1 while the opposite end is connected to the PNT in readiness for data collection using the RVRTC technique Figure 17 COC straight connector 15M 45M Figure 16 A straight connector is inserted to the Neopuff T piece resuscitation tubing Figure 17 Apparatus set up for the raised volume RTC manoeuvres Legend This illustration shows the Neopuff Resuscitator connected to a supply of medical air via the green tubing and the T piece tubing connecting the Neopuff device to the PNT and face mask 51 V 1 June 2014 3 3 Preparation for testing 3 3 1 Laboratory set up and equipment 3 3 1 1 Equipment specifications The ERS ATS infant lung function Task Force has published specifications for equipment used for infant testing and quality control criteria associated with signal processing and data handling Frey 2000 section 7 3 All equipment and attachments must be fully patient isolated and comply to international safety standards note external devices such as USB or other portable drives may not comply with such regulations An important consideration for infant testing is that the flow sensor or PNT should be a low resistance low dead space device with linearity appropriate for the age of the child In addition the PNT should be heated to body temperature during calibration and over th
135. ff T piece resuscitation tubing 51 Apparatus set up for the raised volume RTC manoeuvres cceseesesseceeeeeeeeees 51 LabManager screen display of the suite of lung function testing programe 53 The standard layout of the CareFusion system screen display sssssseeeeeees 54 Screen display Showing menu bar options ccccccecesssssssececeeeseesessaeeeeeeeseeseaees 56 The setting of sampling frequency for tidal breathing program c ssccccee 56 Modification of graphic display for tidal breathing data cccccccccesssssseeeeees 57 Screen display showing selected variables from the Contents of table tab 58 A maximum of 5 trials or Acts are usually permitted for each sub set of tests 59 The preferred settings for the inflation duration of the shutter balloon for single OCCIUSION COSC E E E E EN cade uilsded ee edechevasdiotesbcuscatuadecedecteds 60 Settings for the regression line for the SO data analysis cccsssscccceeeesesseees 61 Variables selected for online display in the result window top right 62 Selecting the sampling frequency for airway resistance and FRC ietn data CON SCEION ENEE E E dicate sadceguaanacceh egancceh S EAE A E E A 63 Recommended settings for FRC OCCIUSION cscsessccececseessesnsaeeeeeeseessessnaeeeeees 64 Selected FRCpietn variables for display in the result WINdOW ccc cesses seee tenes 65 Program menu for setting cr
136. flation was triggered 4 inflated breath there was a minimal delay in terminating lung inflation Consequently the FEFV curve was displaced to the right window B Figure 145 window A shows another example grey FEFV loop and results from Act 1 blue in trend window of poor synchrony albeit less marked than in Fig 144 Although values derived from Act 1 are within 10 of those from the well synchronised manouevre in Act 2 the delayed onset of forced expiration and increased pressurisation may lead to over estimation of FVC and distortion of FEV and FEF values 176 d Best Act Act2 Act3 Act4 Act5 FEV FC 4129 4129 3395 FEV4 1 181 FYC 86 7 1857 181 9 226 2 226 2 207 6 FEV 5 197 0 1970 1927 FEV 75 211 7 211 7 2029 FEVI 2180 2180 2054 205 0 205 0 256 0 4524 4524 4718 140 140 117 527 527 152 61 61 61 79 79 79 298 298 297 1735 1735 1924 Figure 145 Overlaying 2 raised volume RTC trials for comparison of results Legend The raised volume FEFV curve in red Act 2 is technically valid with good synchrony between releasing lung inflation and onset of jacket compression Comparison of values window C confirmed that results from Act 1 are likely to be erroneous and therefore should be excluded Blip at the end of an expiratory flow volume curve Overall the example in Figure 146 is technically valid but for the fact that at the end of the expiratory V V curve there was some active expirat
137. g 80 90 of the data to be analysed with further consideration of other quality control criteria e g mask leak For clarity of online data display in the lower right window Figure 23 B users are advised to modify the red vertical axis to read 50 100 for the parameter Vpe expiratory volume up to tidal peak flow as a of total expired volume V so that the red symbols representing Vpef Vex are not visible Figure 23 A and B This is because Vpef Vex is not a useful outcome mo te Ww mo in 20 Figure 22 Modification of graphic display for tidal breathing data Legend For clarity the red vertical axix for Vpe4 Vex panel B right lower graphic window has been adjusted to show only Tper Tex data since the variable Vper Vex is not a useful outcome Panel A shows the manufacturer s default setting displaying both Tpet Tex and Vper Vex data 57 V 1 June 2014 3 4 3 3 Contents of tidal breathing result table To review or edit the list of variables parameters displayed in the result table top right hand window e Goto menu bar click on Program and Modify settings Click on Settings from the menu bar select modify gt Parameter list gt Contents of Table e Browse through the list of available variables and select relevant ones for display Figure 23 e Click on the Accept button to save contents and OK to exit Tidal 4 60 4 0 Dummy Durneny New test Figure 23 Scree
138. ge and may last lt 10 minutes in a preterm infant this can present a real challenge when undertaking measurements in very young or immature infants Details of how to assess sleep state are provided in section 4 4 7 1 3 1 Studies in unsedated infants Sedation is generally contraindicated for LFTs in newborn infants Successful measurements using a full range of tests can usually be achieved during natural sleep after a feed in infants up to at least 44 weeks PMA With patience and time set aside for a more extended testing period tidal breathing patterns and passive mechanics can be assessed in unsedated infants up to 3 4 months postnatal age whereas forced expiratory manoeuvres and plethysmography generally require sedation 1 3 2 Sedation The hospital specific protocol for sedation should always be followed Although not currently available in the USA section 4 4 3 sedation for infant lung function tests LFTs has usually been achieved using oral or rectal chloral hydrate in doses of 50 to 100 mg kg the maximum dose should not exceed 1 gram irrespective of body weight When prescribing the sedation factors to be taken into considered are a the age of the infant b estimated test duration and c the complexity of the tests selected for the study protocol The prescriber should always aim for the lowest dosage of sedation that facilitates completion of data collection With the exception of a small proportion of high risk c
139. gram Figure 128 An example of a raised volume FEFV curve that has fulfilled the quality control criteria section 6 6 2 is provided in Figure 139 Data in window A shows that after establishment of a stable baseline EEL lung inflation was initiated Each augmented sigh like breath was held until volume and Pao achieved stable plateaux to ensure lung volume is fully extended to pre set PIP of 30 cmH O prior to forcing flow using optimal P determined during tidal RTC manoeuvres from raised lung volume The stable zero flow crossing across the augmented breaths indicated that the expiratory duration was sufficient to allow for complete emptying before the start of the next lung inflation i e taking care not to introduce PEEP However in some younger infants who are not relaxed several rapid lung inflations initially may assist inhibition of inspiratory effort these should be followed by augmented breaths with longer expiratory time to prevent introduction PEEP prior to executing a RVRTC manoeuvre The raised volume FEFV curve in window B illustrates that PEF was achieved rapidly and expiration continued beyond FRC For quality control purposes it is important to check the precise pressure delivered at the airway opening rather than the set pressure for the squeeze breath Pj This is because small differences in P will result in significant differences in FVC FEV and FEF For the RV curve shown in Figure 138 the Pj was 2 89 kP
140. h may reduce the ability to detect subtle changes in lung and airway function in those with respiratory disease Full details of data collection and analysis and quality control criteria are presented in sections 3 4 4 5 3 and 6 3 2 4 Plethysmographic assessments of lung volume Measurements of lung volume are essential for accurate interpretation of respiratory mechanics and may be a valuable means of defining normal lung growth However the only lung volume that can be measured routinely in infants is the resting lung volume at end expiration i e the functional residual capacity FRC This does not provide information on the number and size of alveoli nor the surface area available for gas exchange Furthermore the ability of the lung to expand to fill available space after surgical repair may limit the clinical value of measuring lung volume in young children with congenital lung hypoplasia Reduced FRC due to restrictive lung disease may be found in young children with rare lung conditions e g interstitial lung disease or hypoplasia but this pattern is more common in children with 35 V 1 June 2014 disorders that affect the chest wall or in those with surfactant deficiency or atelectasis due to conditions such as respiratory distress syndrome RDS The commonest abnormality of lung volume during infancy is that associated with airway obstruction wherein both hyperinflation due to dynamic elevation of lung volume in th
141. half its initial value used to determine a specific magnitude of box leakage to ensure stability of the box signal while retaining its integrity 90 V 1 June 2014 the calculation of a calibration factor for changes in plethysmographic pressure by delivering known cyclical volume changes using an internal calibrated sine pump and measuring the resultant change in box signal e of the 3 trials the median value of the time constant acceptable range 7 10s is selected but this value is not used for any calculation In Figure 63 the left panel shows the box was calibrated satisfactorily whereas the example in the right panel illustrates a box leak during calibration e the lowest value i e lowest coefficient of variability or best quality of the quality factor for body box pressure QPB is selected and the correction factor for body box pressure KPB calculated and applied subsequently to the recorded FRC data NOTE During calibration ambient pressure fluctuations caused by opening closing or slamming of doors vibrations drilling banging etc will cause disturbance to the calibration signals resulting in a high QPB and incorrect correction factor for body box pressure Criteria for acceptability KPB acceptable value 1 0 25 QPB acceptable value lt 3 NOTE If QPB is 2 3 repeat box calibration If QPB is consistently gt 3 contact the CareFusion service engineer If the box calibration is satisfactor
142. hanics using the occlusion technique in infants Airway opening pressure Facemask Because infants frequently dynamically elevate FRC Figure 1 and may breathe in slightly earlier than usual after occlusion it is necessary to extrapolate the linear portion of the flow volume plot to zero flow in order to estimate the appropriate volume change when calculating Crs Since t R x Crs respiratory resistance R can simply be derived as t C Flow Pressure Time AF B Compliance AV AP Resistance AP AF Vy Volume AV Figure 6 Assessment of passive respiratory mechanics using the single breath occlusion technique Legend The volume of air in the lung above the passively determined end expiratory level i e AV is calculated by extrapolating the linear portion of the descending flow volume curve to zero flow i e Vx During periods of no air flow i e airway occlusion and in the presence of complete respiratory muscle relaxation as seen by the attainment of a pressure plateau pressures equilibrate and the elastic recoil pressure of the respiratory system can be measured at the airway opening AP Respiratory system compliance can then be calculated as AV AP Similarly by relating AP to AF respiratory resistance is calculated The optimal duration of airway occlusion is a compromise between ensuring sufficient time for pressure equilibration to occur while making the occlusion brief enough to all
143. he airway opening i e pressure plateau maintained for at least 100 ms with a SD of lt 10 Pa and a deviation between start and end of this period of lt the occlusion is held for 400 ms to obtain a satisfactory pressure plateau with a maximum 143 Shutter balloon test View Medication Program Pred Best Acti Act2 990 928 32 7 323 Act3 Act4 Act5 915 910 31 3 33 0 2 118 7 11 6 2 30 0 318 0991 0 1 8 114 0 118 5 11 2 11 6 238 245 0 315 0 335 0 992 0 984 0 88 7 0 5 100 55 0 5 0 Flow volume Flow ml s Mouth pressure kPa Mouth pressure 1 0 f i EN _ Volumefml T a a 40 60 80 100 120 Time ms Tey 200 400 600 800 1000 1200 1400 1600 0 0 Figure 105 For clarity a single technically acceptable trial obtained using the SO technique is illustrated Legend The result table is enlarged and displayed in Figure 106 Pred Best Act Act2 Act3 Act4 VT 7ka 9 27 32 4 108 0 10 6 2 34 0 293 0 988 15 9390 9 28 32 7 323 118 7 121 6 11 6 11 9 230 261 0 318 0 363 0 991 0 992 18 25 915 910 31 3 330 114 0 1185 11 2 11 6 0 88 0 88 7 10 05 04 100 100 55 0 55 0 50 51 NOTE column labelled with Best refersto the mean values calculated from all valid trials or acts 0 38 038 Figure 106 Results table for passive mechanics Legend The main outcomes are C and R the other variables displayed in the table are ou
144. here 1 and 2 refer to the initial and final conditions of the mass of gas Assessments of FRCpeh are made while the sleeping infant lies within the closed plethysmograph a relatively airtight chamber which can record minuscule changes in pressure 36 V 1 June 2014 due to changes in the infant s lung volume By calibrating the plethysmograph in terms of volume change using a calibrated syringe see section 3 4 11 5 2 changes in lung volume can be recorded through the breathing cycle or during breathing efforts against a closed shutter The infant breathes through a face mask attached to a PNT which records air flow and hence tidal volume in and out of the lungs The PNT which includes a pressure transducer to assess pressure changes at the airway opening P is attached to a balloon shutter that when closed temporarily prevents any airflow see Figure 66 and section 3 4 11 5 3 In the absence of airflow pressures equilibrate throughout the respiratory system such that changes in alveolar pressure can be measured directly at the airway opening Once a stable EEL has been established the shutter is closed for up to 10 seconds thereby enclosing a fixed mass of gas within the lungs the volume of which can be calculated by applying Boyle s law During this period the infant continues to make breathing efforts against the occlusion Figure 8 This causes cyclic expansion and compression of the fixed gas volume Flow mi s
145. hildren e g those with known or suspected upper airway obstruction in whom sedation is generally contra indicated due to the risk of exacerbating symptoms chloral hydrate has been shown to have an excellent safety record and has been administered to thousands of infants worldwide without adverse side effects 25 V 1 June 2014 Although some research ethics committees have voiced concerns about healthy infants being recruited for research studies that require sedation others consider it unethical to sedate vulnerable infants with respiratory disease unless results can be interpreted properly by reference to those in healthy controls see recommended reading section 7 Chloral sedation is best administered via a syringe although the bitter taste of chloral hydrate may cause infants to spit it out or cry In addition both onset between 15 90 minutes and duration of sleep are somewhat unpredictable such that investigators rarely have more than 45 minutes in which to collect the required lung function data 1 3 3 Duration of testing and need to prioritise which techniques to use Given the time required to obtain fully informed parental consent and for the infant to fall asleep parents may need to spend 3 to 4 hours in the infant LFT laboratory This may limit their ability or willingness to attend for repeat measurements at intervals of less than 6 months Caution with respect to repeated sedation also limits the frequency with which se
146. hing program Legend Options for criteria which are related to analysis and quality control are also displayed 56 V 1 June 2014 3 4 3 2 Setting technical criteria for tidal breathing Figure 21 shows settings for the criteria for online analysis including Select number of breaths in on line evaluation set to 50 thus enabling analysis and display of results for up to 50 tidal breaths per trial Number of highest and lowest values to delete in this example Figure 21 the number is set to 5 This means that during online analysis for each trial or epoch of data maximum n 50 the breaths that have tidal volume V within the highest 5 and lowest 5 of the overall mean V will be eliminated so that only those breaths that lie between the 5 and 95 percentile of the total number of breaths will be considered valid and results calculated from these Note The CareFusion s default setting for Number of highest and lowest values to delete is 25 EF eroare rre ree C A r which means only the number of breaths that fall between the 25 and 75 percentile i e the middle 50 percent of total number of breaths recorded during one trial are accepted by the software as valid for final analysis Provided that relatively stable tidal breathing recording is obtained while the infant is in relaxed sleep and breathing regularly the default for Number of highest and lowest values to delete may be set at 5 or 10 allowin
147. hout the plethysmograph and or including the tidal Squeeze and or Raised Volume Squeeze programs Figure 12 see Appendix for supplier section 8 1 47 V 1 June 2014 3 2 2 Resuscitation trolley and suction apparatus Besides the resuscitation trolley containing age appropriate drugs and instruments e g laryngoscopes endotracheal tubes bag and mask suction tubing etc the followings are also essential within the infant LFT lab e Suction apparatus e Pulse oximeter SpO2 monitor e Oxygen and medical air supply 3 2 3 Basic accessories for lung function tests Whichever test is undertaken appropriate size face masks are essential when collecting data Therapy putty is also required to create an air tight seal between the mask and the infant s nose and mouth 3 2 3 1 Face masks Figure 13 Rendell Baker Soucek face masks of different sizes e Available in sizes 0 1 and 2 and suitable for infants weighing 2 15 kg Figure 13and Table 1 see Appendix for supplier section 8 1 e ideally the masks should be transparent and if either plethysmography or the Raised volume RTC technique are being undertaken must be firm to avoid distortion or dissipation of the pressure signal during pressurisation e g the infant s own respiratory efforts against the airway occlusion during FRC measurements or application of external pressure during the RVRTC 48 V 1 June 2014 e Table 1 summarises the dead space of an as
148. i a a AA a a GA AA 31 23 1 WAMROOUCHION s a R A AER E aie oak A R E EE R 31 2 3 2 Passive Respiratory MechanicsS sessseesessssessseesessssesrrerrrsssseserereesessssesrreesesso 32 2 4 Plethysmographic assessments of lung volUMEe s sesssssssssssessssssseserersrssssesereesrssssesee 35 2 5 Plethysmographic assessments of airways resistance cccececesssssaeceeecessessnteeeeeeeens 38 2 6 Rapid Thoraco abdominal Compression RTC or forced expiratory manoeuvres 38 2 6 1 Partial forced expiratory manoeuvres Tidal RTC cccsccccessseceeeesseeeeessees 39 2 6 2 Methodological considerations for tidal RTC manoeuvres cccceseereeeeeeeees 40 2 6 3 The Raised Volume TECHNIQUE ecien aalis aa aiis 41 2 6 3 1 Analysis and Reporting of RVRTC Results cccccssssecececesessesnsaeeeeeeeseeseaeaeeeeeesseeees 42 2 6 3 2 Advantages and Limitations of the RVRTC s sssssssssssssesresssssssrenressssssrrersnsssseserensesses 43 2 7 The role of lung function tests in clinical management of infants cccseeeeeeees 44 2ds Whatis Normal oeiee e e d aa i a 44 2 8 Bronchodilator RESPONSIVENESS ccccccccecssssssssececececessecseaeeececeseeseaaaeceeeceseessaeaeeeesens 45 3 Setting up an infant lung function labOratory ccccsssscecsssssceccssssceccesssesseeesees 47 3 1 Ambient conditio Sessan bee 47 3 2 3 2 1 3 2 2 3 2 3 3 2 3 1 3 2 3 2 3 2 3 3 3 2 4 3 2 4 1 3 2 5 3 2 5 1 3 3 3 3 1 3
149. iance C A measure of distensibility i e change in volume per unit change in pressure Avolume mLkPa A pressure Jacket pressure transmission a absolute change in pressure at the airway opening P during a brief airway occlusion before P1 and during P2 a squeeze manoeuvre Pao i e Pao P2 P1 b when expressed as a percentage P2 P 2 PD x100 jacket pressure Resistance A measure of pressure required to move gas gases at a flow of one litre per second __ Apressure ee aflow IREL Ts time constant of the respiratory system compliance Crs x resistance Rrs s z score measured value predicted value or standard deviation score residual SD 22 V 1 June 2014 1 Special considerations when assessing lung function in infants 1 1 Introduction Marked developmental changes in respiratory physiology occur during the first years of life which affect both the measurement and interpretation of lung function in infants and young children There are also major differences in how lung function is measured in infants when compared with older subjects These differences relate mainly to sleep state sedation ethical issues posture and the need to miniaturise and adapt equipment for measurements in small subjects who tend to be preferential nose breathers and who cannot be asked to undertake special breathing manoeuvres These issues have been described in detail previously
150. id trials are displayed The optimal P was set at 9 0 kPa For the y A blue symbols and A trial red symbols respectively the recorded P were 8 8 and 8 9 kPa Pj 2 89 kPa and 2 84 kPa and Vj 592 mL and 617 mL for the respective Squeeze breath Another example of a valid raised volume FEFV curve is shown in Figure 140 from an infant with airway obstruction in whom a typically concave shape was observed in the expiratory flow volume curve with complete flow limitation at lower lung volumes no increase in expiratory flow observed during the RVRTC when compared with that during passive deflation for the final 30 of expiration Best Actl Act2 Act3 Act4 Act5 Flow mls E FEV FC 554 5 554 5 FEV 4 213 4 213 4 F FYC 341 1 3411 FEV 5 230 2 2302 FEV 75 259 8 259 9 279 8 279 8 104 9 104 9 275 1 275 1 PilkPal E 431 431 46 46 69 69 2 89 289 298 0 298 0 Time s Flow ml s Trial 5 of 5 Volume ml T 100 Trial result alidated by user J Y E off line Pr off line Figure 140 A technically valid RV trial from an infant with airway obstruction Legend The left upper window shows recording of a respiratory pause 3 s following the RVRTC manoeuvre followed by spontaneous onset of tidal breathing 6 6 4 Examples of invalid trials a Glottic activity Figure 141 displays a raised volume FEFV curve Act 2 in red distorted mid flow due to transient narrow
151. igure 18 and open Patient Data retrieve the appropriate folder by keying in either the test ID number or infant s name 135 check that all details on Patient Data screen are correctly entered especially values for weight and length Figure 44 Save any amendments made click and open Test Directory If an infant has been measured on more than one occasion the CareFusion relational database groups the stored data according to the test date in a chronological manner thus users may identify the required dataset easily according to the test date Figure 98 check that the correct weight and length measurements are attributed to each line of data collected on the same test occasion otherwise carefully edit weight and length measurements section 3 4 10 1 Figure 44 and Figure 46 Save and exit Patient Data This last patient folder viewed will be held as current in the database enabling the retrieval of lung function data set for this infant for review analysis NOTE click on F8 to condense the Patient Data page and with the Test Directory displayed on the same page A printed copy is useful for cross checking the infant s test history and detail regarding type of data collected 6 1 1 Setting printer screen dump function e Data and or results displayed on screen can be either printed as paper copy or electronically screen dumped onto a WORD document by pressing the
152. ile waiting for thermal equilibration record more tidal breathing data or move on to collect Respiratory system Resistance Compliance data before switching to Babybodypleth program to continue with FRC data collection remember to open the plethysmograph briefly at least every 15 minutes to clear any accumulated expired carbon dioxide 5 5 Measurements using the tidal RTC technique In spontaneously breathing infants partial expiratory flow volume PEFV curves can be obtained by rapidly applying an external pressure to compress the thorax and abdomen using the rapid thoraco abdominal compression RTC technique also known as the Squeeze technique at the end of a normal tidal inspiration Figure 82 and Figure 83 The main outcome measure of interest is the maximal flow at functional residual capacity V maxerc Figure 82 The process of setting or reviewing the sample frequency and contents of result table has been described in section 3 4 8 Check that all program settings are correct sections 3 4 8 3 and 3 4 8 7 A list of Function keys are available in the Appendix section 8 3 400 Forced expiration a z lt V maxFRC A con 0 Expiration i es Inspiration a n 200 80 40 6 40 Yolume mL Figure 82 An infant undergoing tidal RTC manoeuvre 118 Legend Left the sleeping infant breathing through a face mask and PNT with a jacket fitted snugly around the thorax and abdomen for
153. in kPa right vertical axis e At the completion of each RV trial check the Pj to ensure optimal lung inflation was achieved reproducible V values between trials indicate that the squeeze breaths pertaining to each trial were similar in volume i e similar magnitude of lung inflation e Aim for three minimum 2 acceptable FEFV curves that are reproducible FVC and FEVo 4 or FEVo s within lt 10 variability 129 e Once sufficient data have been collected click on F10 to confirm save and exit program 5 7 Bronchodilator challenge settings for Pre and post medication There may be occasions where an investigator wishes to assess the effect of a therapeutic drug e g lung function measurements at baseline and post administration of bronchodilator BD agent via a spacer inhaler section 2 8 The following section describes the procedure of performing bronchodilator challenge using the RV technique At each RV test session the aim is to obtain 3 technically satisfactory trials section 5 6 1 2 However if bronchodilator responsiveness BDR is a major outcome for the study in order to ensure completion of tests a pragmatic step would be to obtain 2 RV FEFV curves of good quality at baseline and post BD administration 5 7 1 Measurements pre and post bronchodilator challenge e While setting up the equipment for RV manoeuvres section 5 6 1 1 check to ensure that the spacer inhaler is the correct fit for
154. ination is vital to identify potential risk factors for chloral hydrate sedation and suitable subjects for sedated tests 4 4 2 Potential risk factors To establish suitability for sedation prior assessments to identify risk factors include e relative immaturity e g lt 44 weeks PMA due to instability of the control of breathing particularly during REM sleep which occurs more frequently during early postnatal life especially those born preterm e poor weight gain somatic growth e developmental status 99 V 1 June 2014 e current health status or medical condition e physical status including the airway past history of partial airway obstruction constant snoring respiratory pauses during sleep or sleep apnoea e facial dysmorphism e g midface hypoplasia in Apert s or Crouzon s syndrome predisposing to obstructive sleep apnoea e current and previous medication including any allergies e past medical or surgical problems including any associated with previous sedation or anaesthesia Besides ascertaining information regarding a young infant s gestational and postnatal ages it is also important to question parents closely regarding any relevant symptoms including noisy breathing or snoring and posture adopted during sleep history of episode of cyanosis or breath holding or difficulty in swallowing during feeding Although obstructive apnoea is rare in healthy infants presence of respiratory illne
155. ing of the glottis or larynx during forced expiration Although forced expiratory flow appeared to resume rapidly good overlay with curve derived from Act 1 173 shown in grey and this incident did not significantly affect FVC or FEV calculations it resulted in marked underestimation of FEF values see accompanying result table 328 7 1 12 486 392 39 38 49 50 301 297 151 9 150 5 Figure 141 Raised volume FEFV curve with transient narrowing of the glottis or larynx during forced expiration Legend see text for details b Asynchrony between timing of lung inflation and jacket compression Figure 142 window B shows a flow volume curve with a marked delay in jacket compression such that forced expiration commenced after gt 50 of the raised lung volume had already been exhaled On reviewing the time based traces in window A it appears that lung inflation was released early notice the shorter duration of inflation when compared to previous augmented breaths causing the z operator to mis time jacket inflation JAIAN Ma A N 1 VW NF AU 7 a Vi VA Figure 142 Example of a SANA aL raised volume FEFV curve obtained following late jacket fate ieceet we compression window A f E Pe Ai cl a Legend Due to the late jacket compression the onset of forced 10 rme bi 2 expiration was severely delayed start of expiration window B forced expiration jacket compression passive expiration
156. ing remove from the face The user should stand right against the side of the plethysmograph in a position close to the infant ensuring that he she does not roll or fall off the plethysmograph table e Data recording will stop automatically after the set number of breaths e g 15 breaths as shown in Figure 81 following the release of airway occlusion 116 V 1 June 2014 e To terminate the recording earlier click on F6 activating F7 Calculate display results will display FRC and airway resistance results for the specific trial or act e To continue and proceed to the next trial click on F2 continue recording until the box volume signal is observed to be stable record a few more breaths if airway resistance data are required Figure 80 before clicking on F3 to collect FRC data as mentioned above Figure 81 e Provided that sufficient good quality data have been collected click on F10 save and exit program e Gently lift the hood to avoid disturbing or waking the infant e The mean value from 3 5 technically satisfactory trials is reported from each test occasion Shutter balloon test Medication none 2 Menu bar Flow m s Monitor window 2 40 60 80 100 120 Best Acti Act2 Act3 Act4 Window A time based trace a Window c result table delta Pao vs delta Vg 4 m FRCp 0 163 0mL m FRCp 1 159 0mL Window B 34 m FRCp 2 159 9mL volume vs time FRCp 160 7mL K Modification of
157. instead of 1 kPa e Repeat the entire manoeuvre until flow limitation is achieved i e no further increase in V maxerc With increasing P e The lowest P that elicited the highest and reproducible V maxerc at the point of flow limitation is termed the optimal P and will be utilised for the raised volume squeeze manoeuvres e The manoeuvre to assess Pj transmission should always be performed using the optimal P see section 5 5 3 If the measured Pao during the RTC exceeds 3 kPa a lower P producing an optimal V maxerc Pao lt 3 kPa will be used for the raised volume manoeuvres e The mean V maxrrc Calculated from 3 minimum 2 technically acceptable and reproducible trials within 10 variability or 10 mL s of each other will be reported NOTE the maximum P available is 17 kPa but rare that P of gt 10 12 kPa is required provided that the squeeze jacket is fitted appropriately During a RTC manoeuvre dissipation of pressure occurs between the magnitude of pressure set to be delivered from the reservoir P and that measured at the jacket P due to the increased volume of the system once the reservoir is opened to the large bore tubing and bladder Hence the value for P is lower than that for P However the difference between Pj and P should not exceed 50 as this is indicative of a leak between the reservoir and the jacket bladder which would invalidate the trial results 122 WindowA Pj inflation Or
158. inter screen dump FUNCTION ssssssssenssssssereseresssressressrreseresre 136 6 1 2 Retrieving and identifying stored data for analysis ccccssseeecessseeeeeeeenes 136 6 2 Analysis and reporting of tidal breathing data ccccccccccccesssssssceeeescessessnseaeeeeeens 139 6 231 Maim OutCOME Sainer eee tei detetietentn ein Wee anderen entender he 139 6 2 2 Data evaluation oe aeia Bees Pere atuedacdcdie aa aE aaa a aa a 139 6 2 3 Criteria for acceptability nnsnnsesssseseeenersssssseerreessssssesrrersrsssseserereesessssrereene 141 624 Reporting results cvssveeectincieeesies E E AA a EA ee 141 6 3 Analysis and reporting of passive respiratory mechanics data ccccccseessssseeeeeeees 142 6 321 Main OUTCOMES sis csccecsveceencs sted i stdvessees dyes ds Eii Eas 142 6 3 2 Data evaluation maanani aenn n a a a e i 142 6 3 3 Criteria for a cepta pilitya rnn E a EE aE 143 6 3 4 Reasons for invalid trials eeeeeeeeenseeeseeesseseesseseeesssrrrsssrrrrssrrersseererresrensssreens 145 6 3 4 1 6 3 5 6 4 6 4 1 6 4 2 6 4 3 6 4 4 6 4 5 6 5 6 5 1 6 5 2 6 5 3 6 5 4 6 5 5 6 5 6 6 6 6 6 1 6 6 2 6 6 3 6 6 4 6 6 5 6 7 6 7 1 6 7 2 6 8 7 1 7 2 7 3 7 4 7 4 1 7 4 2 7 4 3 V 1 June 2014 Delan o A E E E E E EEE E E eee 145 Reporting res lts iain e e e naiiai 150 Analysis and reporting of plethysmographic FRC data ccessssccececesessssseeeeeeeens 151 Malin QUECOMES e
159. ional information Source of information Are there any reasons for exclusion from study History of apnoeic episode Upper airway pathology Failure to thrive Lack of Understanding Neonatal lung disease Heart lung renal disease Parental psycho social reasons Does your child have any other disease congenital or acquired If so what is the other problem Page 4 of 4 203 8 7 Questionnaire for GOSH CF Referral a Information from parent at first visit page 1 of 4 Study num ber is 3 Test occasion 01 Date TTT Questionnaire for GOSH CF Referral Information From Parent atFirst Visit Only Baby s name aS a L Time of administration otsean S TTT Timectsiep SSCS Time of test commencement o Timeoffeavingtetsite SSCS Cracies sao sao _ pometry Weight ie i Cromie tests C OE or CO fem Whether the child has any atopic disorder Whether the child has developed eczema kanaa a td ease am Pre sedation 204 a Information from parent at first visit page 2 of 4 Study number 5 3 Test occasion 01 Date ITIITI If Nes please aive details Note all symptoms of cough or wheeze should be considered CF related and should not be recorded here Hospital ad missions since birth the following information is required for each Date of admission reso
160. ions anthropometry ccceceesessecececeeessesesseaeeeeeeeessseseaaees 179 Reference equations lung function FeSUITS ccccccccescesssssseeeeeeeeeesseseaees 179 Data back up Storage and export c cccccccssssssssececececeeseseeaeseeeessessesseaeeeeeessessesenaees 183 Recommended Reading List ssssecccsssssceccssssceccssssceccssssceccesssssesesssessesssseeees 185 Background reading and review articles ccccccccccscsssessssececeesceesessaeeeeeeesessesseaeees 185 Sedation and Sleep state marn scccce cscecesgesececbecden svevesenortecsesosdedecetbecdsasvevedeteevecsdervededets 185 Equipment Specifications and signal processing cccssssssccccecessesscseceeeesesssesseaeens 186 Methodological papers relating to infant LF tests cccccsccccecsssesssseceeeeseessessaeees 186 Tidalibreathing e r aee rara ea AA E r A ces davbes Waesienah boven des Rra a 186 Passive Respiratory M Chanics ccssccccccccecessessnsecececeeecsesesseaeeeeeesesseessaaees 186 Plethysmogra phyrre ciir E estes sleet edduea td due ch Ladugseueeeeeb ide vases sdoevaande 186 7 4 4 7 5 7 6 7 7 7 8 7 9 7 9 1 7 9 2 7 9 3 7 9 4 7 9 5 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 8 9 8 10 8 11 V 1 June 2014 Tidal and raised volume RTIC ccsscsccecececsssssscaecececeesssessaeeeeeeeesenessseeaeeeeees 187 Interpretation of data and reference equations ssssssssrsssssesrrrrrrssssesrreenrsssser
161. ipment the manual will inevitably require updating at regular intervals It is the users responsibility to check for such updates However please note that the content of the manual may be out of date at any given time and we are under no obligation to update it No Reliance on Information The content of the manual is provided for general information only It is not intended to amount to advice on which you should rely You must obtain professional or specialist advice before taking or refraining from any action on the basis of the content of the manual We make no representations and provide no warranties express or implied in relation to the information in the manual including without limitation as to the validity reliability accuracy completeness or correct translation of the manual itself and of material contained therein there is no warranty of the results to be obtained from the use of the manual provided and we make no warranties of merchantability or fitness for a particular purpose or use We offer the manual as is and as available and we make no representations warranties or guarantees whether express or implied that the content of the manual is accurate complete or up to date By using the manual you hereby release and forever waive any and all claims you may have against UCL or the providers of data contained in the manual for any losses or damages that might be sustained in connection with your use of the manual
162. iratory effort post airway occlusion Pred Best Act Act Act3 Acts ActS early inspiration 20 w 1000 12 Figure 112 An example of an early inspiratory effort made by the infant following the release of the brief airway occlusion Figure 112 illustrates a single occlusion trial whereby following the release of the brief airway occlusion the infant inspired early see EEL prior to occlusion and over the last 2 3 recorded breaths This may occur due to the fact that a the default for the duration of airway occlusion is slightly too long If this was so shortening the Max occlusion time may help Figure 113 b the infant is not in relaxed quiet sleep Settings Occlusion Measuring mode Single occlusion 1 Occlusion Min breaths before occlusion Figure 113 Edit the duration of occlusion via the Settings Occlusion menu Legend Shortening or lengthening the occlusion time accordingly may facilitate the acquisition of technically satisfactory SO data also see paragraph d above 148 e Glottic activity The screen display illustrated in Figure 114 shows the distorted expiratory flow volume curve when the infant narrowed or partially closed his her glottis larynx Despite a satisfactory Pao plateau during the occlusion there was a large volume intercept Vic kg gt 5 mL kg which further suggests that expiration was not passive and thus Trs cannot be ascertained reliably The trial is not accept
163. iratory muscles such that following release of airway occlusion a more relaxed lower EEL may be observed as demonstrated in this example Two examples of FRC measurements recorded from a 3 month old infant are shown in Figure 120 When plotted graphically AP and AV for individual respiratory efforts measured during airway occlusion were in phase in both examples The benefit of setting the default for airway occlusion to be released i e shutter balloon to be deflated 154 Bem Aal Act Act Acad 4 3 B FRCp O 92 2ml FRCp I 88 mL m FRCp 2 90 0mL FRCp 903mL BFRCp 0 91 Im FRCp 1 90 8mL OFRCp 2 87 4mL FRCp 91 OmL Figure 120 Examples of FRC recordings Legend Examples A and B illustrate FRC data from a 3 month old infant who made 3 complete respiratory i e inspiratory and expiratory efforts against the closed shutter Example B shows how individual efforts can be excluded if necessary although for this particular trial it would not be required after 3 breaths have been detected or after a maximum occlusion time of 10 s is that should AP and AV phasing for one of the occluded breaths be unacceptable e g due to glottic activity and will need to be deselected from calculation the mean FRC value from the trial remains acceptable provided that the 2 remaining loops are in phase and reproducible 155 However if the default had been set to release the occlusion after only 2 occluded bre
164. iratory phase cccccccceeeeees 146 SO test active expiration following release of airway OCCIUSION ccccceeee 146 SO data regression line for the calculation Of Trs ssssessssssnssssessnessssssesenressssene 147 The same SO trial in Figure 109 is reproduced here in both panels where modifications to the regression line have been made to fit a linear portion 147 An example of an early inspiratory effort made by the infant following the release of the brief airway occlusion ssessssssrssssesereesrsssseserresnsssserernessssssreenn 148 Edit the duration of occlusion via the Settings Occlusion MeNU c60 148 Screen display illustrating the effect of glottic activity on the expiratory limb Curing SO al ic erronee rimia ieaie a aaae a a aiaa 149 Examples of Pao plateau recorded during SO measurements ceessseeeeeees 150 Options for viewing FRC Dreaths ccccccccssssssssececcescsssessaeseeeescessessaeseeeesensees 151 Indications of a leak around the face MASK ecsececeessececeesteeecsesaeeeeeetaeeeeseaas 152 Infant plethysmographic FRC measurement see text for details 006 153 EEL was observed to be lower following the release of airway occlusion when compared to that established prior to onset Of OCCIUSION cccesseceeeeeeeeees 154 Examples of FRC recordings c ccccccccssssssscecececsssessnneseeceecessesseaeseeeessessessaaeeeeess 155 This s
165. iteria for tidal RTC measurements csccceeees 66 The Measurement menu displays the recommended criteria 0scccccees 66 Settings reservoir pressure menu enables an appropriate pressure to be Selected prior to each trial cccccsscsccccecessessnececceecesseseeaecececesessesneaeeeeeesseeseaaeas 68 Trigger settings for jacket inflation for the tidal RTC manoeuvres cc606 69 13 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Figure 47 Figure 48 Figure 49 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Figure 56 Figure 57 Figure 58 Figure 59 Figure 60 Figure 61 Figure 62 Figure 63 Figure 64 Figure 65 Figure 66 Figure 67 V 1 June 2014 The synchronized option is the preferred mode for the jacket inflation IMEC AISI seco cs succste asada Pinca ccs witch cd dats ces uth EEEIEE cb uals dee itchdveunncdWevubeoedeo ete 69 The recommended default settings for safety alerts during tidal RTC MANOGCU VIS 05 vecccess esenseca iai a a vagnavyaceravevhecassetacanavess vaghevessdusvevs scadeeaeeads 69 The recommended default settings for the assessment of jacket pressure CRANSIMISSION ss liesesaviek inie iida ok a EEE EL RE iaa E AO i RE 71 Selected tidal RTC variables for display in the result WINdOW ccccccceseesseeees 71
166. itions to those when data are collected for example with air conditioning switched on if that is in use during testing to control ambient temperature e From the LabManager V4 67a Main group screen Figure 18 select and open the Calibrations tab Figure 51 LabManager V4 67a New test Actions Options Program groups IR Volume Calibration o Figure 51 Calibrations tab Box Calibration showing software options Calibrations 3 4 11 4 1 Volume calibration e Click to open Volume calibration Figure 51 e select BabyBody S for infants weighing gt 3 kg Figure 52 81 V 1 June 2014 Select measuring system Figure 52 BabyBody measuring systems S small PNT maximal flow range 1500 mL s suitable for infants gt 3kg XS extra small PNT maximal flow range 800 mL s BabyBody S BabyBody XS suitable for infants lt 3kg e Adjust and fix the support bar holding the PNT in a suitable position and connect the 100 mL calibrated syringe or pump Figure 53 Figure 53 Correct fitting of the PNT into the sensor housing Legend Left the schematic symbol red circle indicates patient side where the face mask should be connected to the PNT Right the calibrated syringe is fitted to the patient side of the PNT Note while calibrating the PNT a perform syringe pump strokes at 30 min b avoid grasping holding the barrel of the syringe to prevent warming the barrel an
167. itz CJ a E z lt e E Window B Figure 87 Display of V maxerc results from an acceptable test Legend This screen display shows results of 3 reproducible PEFV curves with window A showing a real time trace from the 11 trial illustrating jacket inflation pressure of 6 8 kPa achieved using a P of 9kPa which resulted in a V maxerc Of 164 mL s is similar to V maxerc achieved when a P of 7 and 8 kPa had been used resulting in Pj of 5 3 and 6 0 kPa respectively window C and trend window 5 5 3 Assessing jacket compression pressure transmission During forced expiratory manoeuvres the magnitude of jacket compression pressure transmitted to the intra thoracic structures i e driving pressure varies between infants It is therefore important to assess the Pj transmission to assist data interpretation and quality control e Click on F6 to set the reservoir pressure at which flow limitation occurred e Click F5 to select Jacket transmission mode e Click F3 to initially activate inflation of the shutter balloon to produce a brief airway occlusion resulting in rise in P P1 followed by an automatic jacket inflation to effect a squeeze manoeuvre while airway occlusion is maintained notice a 2 rise in Pao P2 e The trial stops automatically after several tidal breaths have been recorded following the deflation of the jacket Figure 88 123 Best Acti Act2 Act3 167 164 18 80 61 214 2 80 60 35 R
168. ke during pregnancy and in those with airway disease Interpretation of results may however be confounded by several factors as discussed below AN AN yy Volume 60 mL 400 a N maxFRC VV A V Y F 200 Flow 100 t O mL sec z 100 Jacket inflation ra agi Jacket _ i i C 40 cm H30 PUSONG mpm 200 Volume mL Time based recording Flow volume loop A B Figure 9 A and B partial expiratory flow volume manoeuvres derived from the tidal Rapid Thoraco abdominal compression RTC technique Legend Jacket pressure usually commences at approximately 30cm H20 and is increased in increments of 5 10cm H O until further increments elicit no further increase in V maxerc i e when maximum flow at FRC is attained FEL end expiratory level 39 V 1 June 2014 2 6 2 Methodological considerations for tidal RTC manoeuvres For accurate and reproducible V maxrrc data it is essential that e any leaks around the face mask are eliminated e the jacket is fitted correctly Note during data collection if the jacket was re fitted the test should re start with a reservoir pressure P of 2 or 3 kPa e astable and representative EEL is established before forcing expiration e flow limitation is achieved An initial P of 2 to 3 kPa is usually selected the lower starting P of 2 kPa is advisable when testing a preterm or very young infant and applied at the end of tidal inspiration with the aim of tran
169. ktop e If not go to C Lab4 and scroll down the list of application files e Identify select and highlight the file Merge5 exe gt right mouse click rmc gt create a shortcut of this file and place it on the computer Desktop gt ra MERGES Step 3 e To extract or merge out lung function combined with patient test data click on the Merge5 Lnk icon and enter the password obtain password from CareFusion personnel Figure A 216 Figure A Illustration showing Merge5 icon on computer desktop and password sign in Figure B Data Utility menu e The user must define the Source data base and Destination data base e The process of locating the Destination data base folder is shown in Figure C see legend e Three options are available when attempting to extract data from C Lab4 DB i merge out a block of data according to dates e g 01 01 2013 to 01 12 2013 217 ii merge out data from one single subject patient use the ID number entered on Patient Data record iii merge out all the data from C Lab4 DB see Figure D and legend Settings Source data base C LAB4 DB Select Destination data base E JaegerB abyBody_DB_BackUp_2013 Create database Select _Options V Do not merge calibral I Include user lists Directories en Include PatientMana Consider date un single patient from Identification OWan 23Dec 20 W
170. l then it would not be advisable to report FRC based on this trial a mean FRC from a minimum 2 ideally 3 5 trials are recommended for reporting b evidence of mask leak and glottis activity during data collection 157 c FRCregression slope e The setting for Regression analysis for FRC can be accessed from the menu bar click on Program gt Modify settings return to the menu bar click on Settings gt FRC Figure 123 window A e The recommended default setting for Regression analysis for FRC is 10 Figure 123 window B which means that the regression line hence the slope is derived after excluding the first and last 10 of the individual V P slope i e encompasses 10 90 of the effort This enables the slow changes that occur at end expiration Pao plateau which could distort results especially in the presence of marked V drift to be exclude Figure 124 mW Ww WWW ekimaneren es ahur aan 8 of ciate F ae at a prense sum of 1 elio Figure 123 Menu for setting FRC regression n slope Legend Window A shows Settings menu for FRC program Regression analysis for FRC may be edited in the panel circle in red shown in window B 158 Figure 124 Construction of the regression slope using 80 of each plotted FRC breath Legend The recommended default for Regression analysis for FRC is 10 i e the 10 of the top and bottom of each plotted FRC breath are excluded These
171. l relating to a specific trial with the right mouse button before re selecting and displaying an alternative previously unselected trial This is done by using the left mouse button and clicking on either the grey circle or square that is associated with a particular trial To focus on a specific PEFV curve click with the left mouse button on the corresponding symbol which will then be identified by a black line Figure 128 identified as Trial 5 of 10 indicated by the red circle in the trend window and the PEFV curve on view in window B in blue as are the corresponding symbols The first two trials are represented by blank symbols Figure 128 trend window indicating that these are technically unacceptable in this case due to early inspiratory effort no results are calculated from these trials and they therefore cannot be re selected Best Act Act2 Act3 106 102 106 99 102 34 nn ou amp Banos 8 Ne 0 6 7 21 8 3 20 9us 133 Trial result Trial valid Status bar Figure 128 Screen display of tidal squeeze data Legend Time based signals are displayed in window A with the 3 best forced expiratory flow volume curves and results shown in windows B and C In the trend window the circles indicate P and square symbols represent the corresponding V maxrrc the 3 best curves selected by the software are displayed in colour blue red and green the grey symbols represent trials
172. l squeeze manoeuvres sections 5 5 2 5 5 3 the magnitude of jacket transmission pressure section 5 5 3 is assessed during tidal squeeze manoeuvres the effect of deep inflation on airway mechanics during the raised volume manoeuvres in infants is unclear the augmented inflations delivered to the infant during the raised volume manoeuvres could influence V maxerc Measurements had the tidal squeeze been performed after the raised volume procedure by performing the tidal RTC prior to RVRTC the number of lung inflations that the child is exposed to and hence the risk of gastric distension is minimised 94 V 1 June 2014 4 Infant preparation 4 1 Infant factors 4 1 1 Health status Lung function measurements are performed when infants are well and free from upper or lower respiratory tract infection for at least 3 weeks However in a patient with a clinical diagnosis such as CF who has frequent recurrence of respiratory exacerbation it may be pragmatic to assess the infant when clinically stable and not currently exacerbated When healthy infants are recruited and measured as control subjects the initial assessments should be made prior to any history of lower respiratory illness and follow up tests deferred for at least 3 weeks after an upper or lower respiratory tract infection 4 1 2 Age range Lung function assessments can be carried out in infants up to approximately 2 years of age Once they have begun crawling or w
173. librations tab showing software options s sssssssssssssressssssererressssssreernes 81 BabyBody measuring sysStemS sssssssssesesresssssseserresssssserernessssssrrernessssssrreenese 82 Correct fitting of the PNT into the sensor housing cccccccesesssssseeeeeeesesseaees 82 F8 is indicated by the redgirl Ennii niini 83 Settings menu offering options for PUMP StrOKeS ccceessssececeeesessesteaeeeeees 83 Screen display of the initial 3 pairs of pump strokes representing Inspiratory expiratory efforts cceecccsseceesseceescecsseecessececssecesseecsseeeesaeceeseeessees 84 Acceptable volume calibration of the PNT ccccccccccccsssssssssceeeeseessesssseeeeeeseeeees 85 Unsatisfactory volume calibration cccccccccccecssssssssecececscessesnaeeeeeesesssessaaeeeeess 86 Window displaying ambient CONCItIONS cccccccececessessneeceeeeeceseeseaeeeeeeseeeees 88 Ensure that the rubber stopper is firmly in place prior to box calibration 89 Box calibration icon indicated by the red Circle ccccccceessececseseeeeesseeeeeeees 89 A period of 2 3 minutes are required for the closed box to stabilise 90 Box calibration examples of recorded trials of half life time constant VASO CONS a AE acd svenes cs90 abla ended Savh wan EI EAE AA EAR 90 Option for Shutter balloon test is highlighted by red Circle cccccccceeeseeeees 92 Shutter balloon test
174. limb beneath the regression line was not linear In Figure 111 two approaches were used to determine T by adjusting the regression line note click on the adjusted regression line to re calculate r value However besides obtaining different values for Ts i e multiple Trs neither of the approaches attempted met the quality control criteria see figure legend and this trial should therefore be deselected from final calculation Figure 110 SO data regression line for the calculation of Tys Legend The regression line was fitted automatically by the program according to the default settings section 3 4 5 However it can be seen that the expiratory limb over the regressed portion was not linear Flow ml s Flow ml s 6004 s004 400 3004 2005 1004 _Volumefml 1 140 Voluiic i 140 0 T T T T T T 60 80 100 120 Figure 111 The same SO trial in Figure 109 is reproduced here in both panels where modifications to the regression line have been made to fit a linear portion Legend In each example by manually selecting Veocc portion that is linear not only the Veoce portion may be unacceptably small lt 30 the T re calculated obtained by clicking on the regression line would be entirely different according to the two approaches This trial should be deselected from calculations due to alinearity and absence of a single time constant 147 d Early insp
175. lly Act2 Act3 129 Airway occlusion baseline EEL Window C Jacket inflation Figure 135 An unacceptable jacket pressure transmission check Legend Following a stable EEL a P manoeuvre was triggered a step up in EEL was observed following the release of airway occlusion window A During airway occlusion although there was rapid pressue equilibration and a satisfactory P plateau P1 initially during jacket inflation there was a 2 rise in Pao but this was not sustained to a plateau window B due to a mask leak This may be associated with an increase in mouth pressure within the mask This trial therefore is not valid Note that despite the failure to meet quality control criteria a value of 1 95 kPa was displayed for Pao j window C Note The mask will need to be re applied to establish a leak free seal before continuing with data collection If under pressure to complete the study protocol e g due to restlessness of infant it could be inferred from this Pj transmission check that adequate P has been transmitted for this study 168 6 5 6 Reporting results mean V maxrrc Calculated from the 3 minimum 2 technically acceptable reproducible curves i e within 10 or 10 mL s whichever is greater of the next highest value is reported Note as FRC is an unreliable landmark and varies with deadspace sleep state and breathing pattern reporting mean V maxerc rather than Best is recom
176. low of 8 12 L min to the Neopuff Infant the Resuscitator system Prior to connecting the Neopuff T piece connector to the PNT mask already in place over the infant s airway opening Figure 90 it is vital to check that the PIP is set appropriately at 30 cmH 0O 2 94 kPa this can be done by closing off one end of the Neopuff T piece and intermittently occluding the PEEP end to read off the PIP setting from the Neopuff system Figure 15 Prior to commencing RV manoeuvres the medical air flow needs to be titrated and checks made at each test session to ensure that in accordance to consensus section 7 4 4 lung volume is augmented using PIP of 30 cmH O0 Note The larger the expected FVC the higher the medical air flow should be set such that the infant is not being inflated too slowly as he she may start to actively breathe in before full inflation or too rapidly difficult to trigger the squeeze on time However if medical air flow is set gt 10 L min care must be taken to check that PIP does not exceed 30 cmH 0 126 Click on F1 to begin monitoring breathing pattern display in Standby panel if necessary perform an occlusion test to confirm satisfactory mask seal Click on F2 to start tidal breathing recording as soon as the reservoir pressure reaches the pre set level F3 icon is illuminated Insert the straight connector with the Neopuff T piece to the PNT see Figure 16 Figure 17 and Figure 90 Observe th
177. lve We would like to see your child yearly and perform the following tests 1 Clinical examination by a Respiratory Paediatrician We will check on your child s growth and examine your child s skin lung cardiovascular and neurological system We will look at your child s developmental milestones and ask you some questions about your child s health 2 Skin prick test We will test for allergies against house dust mites pollens dog and cat fur by placing a drop of allergen extract on your child s forearm Using a sterile lancet a small prick through the drop is made This allows a small amount of allergen to enter the skin If your child is allergic a small mosquito like lump will appear at the site of testing over 15 20 minutes Oral antihistamines should be withheld for 72 hours before this test 3 Lung function testing To gain information about the lung growth and the airway function of your child it is necessary to measure lung function As infants are too young to collaborate they need to sleep during the test which is achieved by giving a sedative called chloral hydrate We help them taking a big breath in by gently filling their lungs with air from a pump while they sleep We assist them to blow out as fast as they can by wrapping an inflatable jacket around their chest and when their lungs are full inflating the jacket We have a short film available for you to watch that shows the lung function test in detail Th
178. ly qualified staff who have ideally spent at least 6 months training in a specialised centre e The authors have no commercial interest in this product and have received no funding from the manufacturer to produce this manual e It should be noted that the current CareFusion infant pulmonary function testing system was developed over 10 years ago and as such does suffer from various limitations which will be highlighted where relevant together with recommendations as to how best to overcome these problems until such time that the software is upgraded V 1 June 2014 e t should be noted that the BabyBody device is not designed to assess partitioned lung volumes and that although a program has been included to assess plethysmographic airways resistance such measurements are not currently valid in infants as will be discussed below e The contents of this manual cannot substitute for reading the extensive literature in this field including that recommended in the reading list provided e Inthe event of noting any errors please contact us so that amendments can be made s lum ucl ac uk joerg mattes newcastle edu au j stocks ucl ac uk e t should be noted that two qualified investigators at least one of whom is clinically qualified and both of whom are fully trained in basic advanced life support skills MUST be present at all times during infant lung function testing Changes to the Manual With subsequent upgrades of software and equ
179. mended 169 6 6 Analysis and reporting of Raised Volume RTC data 6 6 1 Main outcomes FVC obtained using 30 cmH 0 of lung inflation pressure FVC39 FEV 4 0 5 0 75 FEF2s 75 and FEF 5 The calculation of FEV and FEF is illustrated in Figure 136 and Figure 137 Jacker inflated a FEW 4 FYC Time 5 0 0 4 0 7 Figure 136 This volume time trace shows the calculation of FEVo 4 following a raised volume RTC manoeuvre In this example forced expiration was completed by 0 7 s 900 Flow mL s 600 300 expiration FYC 150 100 50 0 50 Volume mL Figure 137 RVRTC flow volume curve illustrating flow partitions in relation to FVC 170 6 6 2 Criteria for acceptability no evidence of leak during data collection Pint pre set at 30 cm H20 2 94 kPa acceptable range within 5 of 30cm H O0 i e 2 79 to 3 09 kPa or 28 5 to 31 5 cm H20 P used optimal reservoir pressure ascertained during tidal RTC manoeuvres for the squeeze breath precise synchrony of jacket inflation operator 1 with the ending of lung inflation operator 2 is crucial so that there is a rapid rise time at start of forced expiration P compression time at least 1 second to ensure complete forced exhalation forced expiration should continue beyond FRC with a smooth expiratory curve 6 6 3 Data evaluation The raised volume squeeze window display is similar to that for the tidal Squeeze pro
180. misinterpretation even when potentially appropriate equations are used can lead to serious errors in both under and over diagnosis with its associated burden in terms of financial and human costs It is important to remember that lung function results from healthy individuals and those with respiratory symptoms or disease often overlap to such an extent that a result within the normal range does not exclude disease Similarly while abnormal lung function results are often associated with symptoms and disease they may simply be atypical and must always be interpreted in the light of all other clinically relevant information Clinicians in respiratory medicine have become familiar with the concept of expressing lung function as percent predicted observed predicted 100 where the predicted value is derived from reference equations The median predicted value is 100 and any deviation from 100 indicates an offset from the predicted value A better approach to reporting lung function measures is to express results as Z scores or SD scores The Z score is a mathematical combination of the percent predicted and the between subject variability to give a single number that accounts for the age and height related lung function variability expected between comparable healthy individuals The upper and lower limits of normal ULN and LLN are conventionally defined as Z score of 1 64 a range that encompasses 90 of healthy subjects H
181. n it can be seen that EEL 2 failed to return to the pre occlusion baseline The step up in EEL is indicative of a leak around the face mask 109 V 1 June 2014 e Once the mask with PNT have been re applied and a leak free seal is secured over the infant s nose and mouth record 1 2 trials or epochs of data each consisting of 30 50 tidal breaths depending on requirement or study outcome e As recording of each trial is completed the program software applies a drift correction factor to the data and calculated results are displayed online e At the completion of the initial trial with a test occlusion click on F2 and the symbol red circle Figure 75 to view the drift corrected data In this example the stable EEL post occlusion suggested that the mask seal was air tight Click on F9 to save this trial and continue to record more tidal breathing data tisavaco4 0 zameno azam IiE Window A Window C D UE W Figure 74 Window A illustrates marked volume drift due to leak around the face mask Legend Although there was an apparently stable upward EEL window A the corresponding poorly overlaid flow volume loops window B and a tidal volume of 3 6 mL kg window C are strongly suggestive of a leak around the mask The red vertical axis for Vper Vex has been modified to hide this variable 110 V 1 June 2014 0 10 10 160 19 Figure 75 Time based tidal breathing trace after drift cor
182. n assessing lung function in infants sssssecsssssee 23 1 1 VEO DUCTION aina adh aeaaeae Re cu aa a cites a eae a aa iaae E Ee ev aa a 23 1 2 Developmental changes which may impact ON ASSESSMENLGS sscccccecessssstteeeeeeees 23 1 2 1 Background orreen wis paca tani iaa Ea e AEREA EEEE a EEEE TE AARETE wee 23 1 2 2 Dynamic elevation of end expiratory level sssssssessesssssseseeessssssesrreesessssene 24 1 2 3 Influence of the upper airwayS ssnssssssessseesrssssesererrrssssosrrerersssssseerreenessssene 24 1 3 Sleep state sedation and duration of the testing procedure s essssssesssesrsssssessreese 25 1 3 1 Studies in unsedated infants sseesesessssesssessseesseessrersreeseresseesstessresseesseresees 25 W32 SSOGAGIOMN aeniea n da a e a e a a a aa 25 1 3 3 Duration of testing and need to prioritise which techniques to use 26 1 4 Which infants can be tested occurron ea a aah 26 1 5 EQuipmient requireMents c c25 c5 E cee So T E ctchedcesscaceceetcueveense 27 1 6 L aks andidead Spaces oesencck cccdes dea ceedodedass aE a a cheat ova lat ca less sa eto inde eas bas ee aie et 27 2 Brief Theoretical Background to Selected infant LFTs cccssssssccssssceceeesseeceeees 29 2 1 Introduction Which test WHEN cc eeccceeeeceeeeeenaeeeeseeceeeeeceaeeeeaaeeeeaeeseaeeeeaaeeneaaeeeeees 29 2 2 Tidal breathing A E E E E A ens E E E 29 2 3 Respiratory Mechanics sii erros anene e e
183. n display showing selected variables from the Contents of table tab Legend The variables selected will be displayed in the result window indicated by red rectangle and red circle respectively NOTE e Each run or epoch of data collected is known as trials or Acts e Amaximum of 5 trials Acts are permitted in tidal breathing Resistance Compliance and FRC programs whereas gt 5 trials are possible in the Tidal and Raised Volume Squeeze programs e Data related to each trial or act are represented by different colours Figure 24 58 V 1 June 2014 Trials Acts easg 1 2 34 5 Figure 24 A maximum of 5 trials or Acts are usually permitted for each sub set of tests Legend Right the trials acts are represented by different colour smarties or buttons Left The screen display shows two trials of tidal breathing data with results which are indicated by the blue and red buttons marked by the red circles 3 4 4 Passive respiratory mechanics Crs and R program settings It has previously been mentioned section 3 3 1 3 that the Double occlusion DO technique is also available for the assessment of passive mechanics of the respiratory system but such assessments do not add further information to measurements obtained using the single occlusion SO technique Goetz et al 2000 section 7 4 2 To avoid prolonging the test session it is not recommended to use both the Do and SO techniques to asses
184. n for admission hospital name date of dischars whether in patiant teatment r a respiratory infection included LY amtibiotics Duration and type of any ventilation oa a Mode Modes med fer chest i i SS ne For each parameter record sumber of course and name of drug if applicable received since diagnosis Any operations since birth Whether the child has ever needed mechanical ventilation since birth Date ventilation sared __ No of days ventilated 205 a Information from parent at first visit page 3 of 4 Study num ber Test occasion 01 Vitamin cupplements Has your child ever been prescribed a bronchodilator Yes Has your child had a bronchodilator in the last 12 hours Hours since bronchodilator given Has your child had a cold in the last3 weeks Yes No URTI in last 3 weeks No Yes but asymptomatic for days Yes and still symptomatic How often has your child coughed and has he she wheezed in the last 7 days Cough None With phyin only Not just with physio but uot daily Where Fa No Don tKnow No of bours since last physio session Mother s smoking habit How many cigarettes a day did you smoke during your pregnancy Not at all Yes Number of cigarettes per day Unknown If save up when Weeks Does mother smoke now No Yes cigarettes 2 day Does mother s partner smoke now No Yes cigarettes a day CF GOSH 206 a Information from parent at first vi
185. n has not been triggered a warning message appears to alert the operator of an unexpected rise in P Occlusion warning threshold similarly a low threshold e g 0 2 kPa is set to ensure that if an unexpected rise in Pao is detected even though no shutter occlusion has been triggered the warning message Airway may be occluded is displayed to avoid a potential risk of an accidental airway occlusion 3 4 8 7 Setting criteria for assessment of jacket transmission The magnitude of jacket pressure that is transmitted to the intra thoracic structures during a squeeze manoeuvre varies between infants In order to assess Pj transmission it is necessary to measure P P1 during a static airway occlusion at end tidal inspiration followed by jacket inflation at the optimal P while maintaining the airway occlusion to record a second Pao P2 The difference between these pressure plateaux P2 P1 represents the P transmission Pao which should generally be 2 kPa except for infants with marked airway obstruction in whom flow limitation is achieved at lower pressures The default settings for assessing jacket transmission are shown in Figure 37 Occlusion time before jacket compression This may be set between 0 2 and 1 5 seconds The ideal occlusion time depends on how rapidly alveolar pressure equilibrates throughout the respiratory system during an airway occlusion which is achieved by the inflation of the shu
186. nce i e rapid lung emptying due to stiff lungs or increased elastic recoil F marked expiratory grunting may occur in the presence of decreased functional residual capacity or stiff lungs to increase the expiratory time constant Attempts to quantify such patterns have resulted in various descriptions of the tidal flow pattern such as the time to peak tidal expiratory flow as a ratio of total expiratory time tprer te Figure 3 This index sometimes referred to as the tidal breathing ratio may be reduced in the presence of airway obstruction and has been shown to be a valuable outcome measure in various epidemiologic studies investigating early determinants of airway function However tprerite is only distantly related to airway function and as with most tidal breathing parameters conveys mixed information on the interaction between control of breathing and airway mechanics thereby requiring cautious interpretation especially within individual infants and children It has not been found to be discriminative in infants with cystic fibrosis CF or those recovering from broncho pulmonary dysplasia BPD Full details of data collection and quality control criteria for tidal breathing analysis are presented in sections 5 2 2 and 6 2 3 30 V 1 June 2014 Volume Flow Time Time a Time based trace of tidal volume b Time based trace of tidal flow Figure 3 Time based trace of tidal volume and flow Legend In addition
187. nd inflation pressures are essential to assure accurate results since e leaks around the face mask occur more easily during positive pressure inflations e some children particularly those with severe airway disease will not relax sufficiently or will consistently inspire before RV is reached thereby invalidating calculations of both FVC and FEF 43 V 1 June 2014 e repeated inflations may result in accumulation of gas in the stomach which will be uncomfortable for the child and invalidate the results see above e the lung inflations required during RVRTC may also affect subsequent measures of lung function such that important decisions need to be made regarding the order of tests within a protocol e finally considerable caution is required in infants who are oxygen dependent in whom repeated lung inflations and subsequent hypocarbia might lead to prolonged apnoea 2 7 The role of lung function tests in clinical management of infants The clinical usefulness of any lung function test within an individual infant will be enhanced if serial measures can be undertaken However the frequency with which LFTs can be repeated during infancy is limited by the need for sedation and the time consuming nature of the tests When requesting such LFTs it is essential that the choice of tests is based on the question to be answered and knowledge of the suspected underlying pathophysiology rather than simply on the equipment that happens to be a
188. nd or soft toys since isolated pockets of air may lead to poor equilibration within the plethysmograph resulting in sub optimal or multiple time constants Data should only be recorded and saved when the infant is sleeping quietly has adapted to the mask PNT and is breathing regularly 3 3 1 3 LabManager Interface The LabManager Main Group tab shows the available suite of software programs Figure 18 namely tidal breathing TB plethysmographic functional residual capacity FRCpieth respiratory system resistance R and compliance C using the single and double occlusion techniques the tidal Squeeze or tidal RTC program and the raised volume RV Squeeze or RVRTC program LabManager V4 6 74 Dummy D ummy New test Actions Options Progam groups ey ey Patient Data Printer Report Screen Report 4 j ix Mh Paar Maryt Tidal Breathing analysis Baby Baby Res Compliance Bodyplethysmography lx K Squeeze Raised Volume Squeeze Zi Off Line Ings Trend Report 1 702004 09 10 2013 1223 16PM Figure 18 LabManager screen display of the suite of lung function testing programs Legend The menu bar at the bottom of the page shows various tab sheets The standard layout of the software program screen is shown in Figure 19 53 Program Settings Measuring system BabyBody 5 EI AIEN Medication none V 1 June 2014 Test program version number infant ID date amp
189. ndow clicking on F1 will start the process of exporting the lung function datasets from the Database in in Wordpad format which can be opened and read as Excel worksheet Once the downloading process is completed go to C Lab4 DB Click on the column Date modified to search for RC 001 Tidal 001 files denoted by the date when the download is made Select and highlight the RC 001 Tidal 001 files one at a time gt right mouse click gt Open gt select Excel from list see Figure E to read results in Excel worksheet 221 Hosta AFH benyeaynty B Bocht HD Rabyey LABI Phew Boch We ET Ne em aws me i eens ca ii be Figure F Illustration showing the process of selecting a text file and displaying results in an Excel worksheet Sq_expt Lnk this icon file enables the user to download numerical values from the test data using the following three programs a Bodyplethysmograph b tidal Squeeze Sq_exptirk c raised volume Squeeze e Repeat the process by clicking on the Rc_exprt Lnk icon and F1 to export lung function datasets see above Step 4 e Once the downloading process is completed go to C Lab4 DB e Click on the column Date modified to search for PLSQO01 txt file denoted by the date when the download is made a summary of the download is denoted by the file SUMO001 txt e Select and highlight the PLSQ001 txt file gt right mouse click gt Open gt select Excel fr
190. near expiratory flow volume curve does not necessarily indicate relaxation of respiratory muscles or the presence of a single passive time constant since a linear descending slope could represent either balanced respiratory muscle activity or reciprocal changes in compliance and resistance as lung volume decreases Analysis of the passive time constant is limited to the linear portion of the flow volume curve when any muscle activity has supposedly been inhibited consequently R measurement may reflect the dimensions of the airways under passive conditions but cannot reflect the dynamic changes that normally occur throughout the breath thus this may limit the clinical value of Rss measurements within individual infants 6 3 4 1 Examples Acceptable trials The three SO trials shown in Figure 107 fulfilled the criteria listed in section 6 3 3 The relaxed expiratory phase indicated a singe t and comprised 50 of V note relaxed Pao plateau not shown The C and R results are reported as mean values Figure 107 Relaxed expiratory phase from 3 single occlusion trials 145 b Alinear or active expiratory phase Both Figure 108 and Figure 109 show examples of active and or non linear expiratory phase following release of airway occlusion please see figure legends for details 450 Flow ml s 8 30 36 3 51 03 6 8 7 16 0 385 Volumefml 60 Figure 108 An invalid example of SO test due t
191. ned prospectively Note Depending on individual institutions and their locations notification to the Human Ethics Committees may be required for granting a waiver if lung function data are to be audited retrospectively for reports or publications A formal application and approval may be needed should the data be used retrospectively within research settings 96 V 1 June 2014 4 3 2 2 Clinical examination Once the infant has settled after arriving to the lab his her baseline vital signs oxygen saturation heart rate and respiratory frequency are checked and documented A physical examination including chest auscultation is carried out by a paediatrician or a trained sedation nurse practitioner to ensure physical well being of the infant and that there are no contra indications to chloral hydrate sedation Care must be taken to identify occasionally an infant who is otherwise well but presents with an elevated heart rate that is likely to be associated with an undetected or unreported fever In this instance the tests must be deferred Examination details should be documented in the test questionnaire and lung function summary sheet see section 8 8 4 3 2 3 Anthropometric measurements Since respiratory function parameters are closely related to body size it is essential to obtain accurate weight and length on every test occasion to aid interpretation of lung function data 4 3 2 3 1 Body weight e Shortl
192. ng inoperable Use the approved cleaning methods listed below for the Vmax components to include the flow sensor sputum trap balloon valve assembly corrugated tubing clear and blue canopy inserts and rubber mouthpieces General Guidelines 1 Always follow the instructions supplied by the manufacturer of the solution or system being used 2 Proper cleaning is usually a two step process Wash with mild soap and water then use a high level disinfectant or sterilization method from the lists below 3 All cleaning solutions must be thoroughly rinsed off the Mass Flow Sensor wires with water using mild agitation Any disinfectant that remains on the sensor pins could cause the system not to calibrate Since there are many different properties in tap water around the world it is recommended that distilled water be used Using tap water could result in the rusting of the sensor pins Approved Sterilization Methods Temperatures below 130 degrees F Glutaraldehyde solutions at 2 6 or below ETO on COLD cycle The Sterrad system Hydrogen Peroxide 58 Approved Liquid High Level Disinfectants Cidex OPA Ortho phthalaldehyde 0 55 Cidex Glutaraldehyde 2 4 Metricide Glutaraldehyde 2 6 Wavecide Glutaraldehyde 2 5 Procide Glutaraldehyde 2 4 Sporox Hydrogen Peroxide 7 5 Madacide FD Isopropanol 21 amp Dowanol 0 3 Sporicidin Phenol 1 93 amp Glutaraldehyde 1 12 Vmax Canopy Spray disinfectant or wipes Vmax Body Box Windo
193. ning with Setting Evaluation amp Display menu showing the criteria to define the expiratory portion of the flow volume curve over which linear regression should be performed to determine 1 Figure 26 Baby RIC V4 65a 53252 New test Flow ml s 400 200 100 0 Settings Occlusion Measuring mode 100 Single occlusion 200 Double occlusion 1 Occlusion Min breaths before occlusion 6 5 Min occlusion time 400 E ms IV Automatic plateau recognition 2 Occlusion Activate at volume 45 fq x left in the tuna Min occlusion time I Automatic plateau recognition Max occlusion time 1500 E ms Plateau definition Minimum plateau duration 100 E ms 70 ms Max pressure deviation Max pressure deviation 2 00 a 00 Max standard deviation Max standard deviation fro re fo fra Max occlusion time 600 ms Plateau definition Minimum plateau duration Mouth pressure Time ms 200 400 600 800 1000 1200 1400 1600 Figure 25 The preferred settings for the inflation duration of the shutter balloon for single occlusion test Legend The criteria for defining a satisfactory pressure plateau at the airway opening during a brief airway occlusion 60 V 1 June 2014 Baby R C V4 65a Martin Molly 53254 New test x Program Settings Measuring system BabyBady S Shutter balloon test View Medication Settings Evaluation amp display x Regre
194. nnaire background information ccccsccccececessessssececeesseesesssaeeeeeeeseesa 200 Questionnaire for GOSH CF Referral ecceesseesseceeceeceeeeeeaeeeeaaeceeaeeenaeeesaaeeneaaeeeeees 204 Lung function test summary SHEE cece ceessssececececesseseeaeceeeeseesseseaeseeeeseesseseaaees 212 An example of infant lung function FEPOFt ee cecsesssecececeseesesseseceeecessessnteaeesesens 213 Backing up making a copy of the CareFusion BabyBody system Database 215 CareFusion Masterscreen BabyBody Equipment c c ccccssesessssseseseseseseseseseseseees 224 12 V 1 June 2014 List of Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Dynamic elevation of lung VOIUMEC cccccccecessssssseceeeeecesseseaeaeeeeeceseeseeaeeeeeeseesees 24 Patterns of tidal flow volume IOODPS ccccccceceseessssececececesseseaeeeeeeecesseseaeeeeeeseneees 30 Time based trace of tidal volume and flOW ccsececeesseeecsesteeecessteeeceeseeecesneeeeees 31 An airway occlusion at end inspiration in infants invokes the Hering Breuer reflex resulting
195. ntly placed over the infant s nose and mouth then delicately mould or press down on the putty around the mask rim to create an airtight seal with the face Figure 71 107 V 1 June 2014 Figure 71 A sleeping infant breathing through face mask and PNT 5 2 2 To start tidal breathing TB data recording e Double click on the Tidal Breathing program icon Figure 18 to open it e The programm will start with a reminder to perform volume calibration Figure 72 If calibration was performed and acceptable click OK and proceed to data collection This message will also appear at the start of off line analysis click on OK to proceed Dummy Dummy 10001 60 04 09 2013 16 39PM a ee ee ee e Calibrations xd Ple ase pertorm volume calibration Flows MS 6B Figure 72 Reminder to perform PNT volume calibration Legend Although this is automatically prompted at program start prior to data collection it will also appear during off line analysis The infant s name test number will be displayed along the top of the window as indicated by the red rectangle box At the start of a test session typically in tidal breathing 108 V 1 June 2014 program it is a good practice to double check the infant details to avoid collecting tidal breathing and all subsequent LF data into a wrong record file At the start of program Flow Volume zero adjustment is automatically performed by the software If infant or m
196. o active expiratory phase Legend Although the Pao plateau obtained during the same trial fulfilled the quality control criteria see inset for measurements the expiratory phase was active and the portion with regression line was markedly reduced This trial is not acceptable for calculation of results gt Volume ml at Figure 109 SO test active expiration following release of airway occlusion Legend In this example both the expiratory phase and the P plateau see inset for results appeared satisfactory However active breathing or push towards the end of expiration was evident To avoid the alinear portion adjust the linear regression portion to avoid the push at end expiration for Trs calculation taking care not to include the early expiratory portion following end of airway occlusion minimum linear portion should be 40 Provided that there was at least one or two other trials at the same test which are technically acceptable and have similar results to the example shown here this trial might be included in the calculation of final results for C and R s 146 c Multiple time constants Figure 110 and Figure 111 shows an expiratory flow volume portion from the same SO data Although a regression line for the calculation of Ts was fitted automatically over the correct expiratory portion 55 5 of Veocc by the software program it can be seen from Figure 110 that in fact the expiratory
197. o start raised volume RTC data recording cccecsesssceceeecessessneceeeeeeessessnseseeeeeens 126 5 7 Bronchodilator challenge settings for Pre and post medication 00e 130 5 7 1 Measurements pre and post bronchodilator challenge cc cccceesseeeeees 130 5 7 1 1 Baseline measurements prior to bronchodilator challenge c ccccccccsssssssseeeeees 130 5 7 1 2 Preparation and measurements post administration of bronchodilator 131 5 8 On Completion Of tests ccccssscccecsssessnseseceeecessesesaeeeeeeseesseseaaeeeeeessesseseaaeeeeseseeesees 132 5 8 1 Post test phone call to Parents ccccscccecececessessnsececeeeeseesssseeseeeeeesenseesenaees 132 5 8 2 Hygiene infection control cleaning and disinfecting equipment 132 5 8 2 1 Hand WY gieness 3i cosesieostlesesceeiieeaalednaacdeies iewehlesaacdeH ounseled sade A E a e EAE aE 133 5 8 2 2 Cleaning and disinfecting at end of test session cccsccccccccessesssssceeeeecessesssteseeeeeens 133 5 8 2 2 1 Apparatus accessories and surfaces ccccsccccecessssssssseceeecessessaeseceeeceseessaeseeeesens 133 5 8 2 2 2 PNT and balloon Shutter siiin aa ea aaa aaia 133 6 Data interpretation and management sssssssssssssssossssoossssoosessossessosssssossessosses 135 6 1 Preparation for data Analyses cccccccccccscsssesssseseceeecesseseeaesececeesssesesaeseeeessessessaaeees 135 6 1 1 Setting pr
198. of ILFTs will inevitably take longer have a higher failure rate and find it more difficult to complete a complex protocol within the limited time that the infant remains in quiet sleep As a general rule it is better to start by mastering the art of high quality leak free assessments of tidal breathing and passive mechanics before proceeding to more complex assessments such as plethysmographic FRC or forced expiratory manoeuvres Similarly it is strongly advised that the operator is highly skilled in obtaining reliable measures of maximum flow at FRC V maxerc using the tidal squeeze technique before attempting the more complex raised volume technique which requires considerable co ordination within and between operators Needless to say attempts to assess bronchodilator response should never be undertaken until the operator is confident that accurate reproducible measurements are possible at baseline The order of testing will be dictated to some extent by which outcomes are seen to be most relevant in each particular case However it should be noted that tests involving forced expiratory manoeuvres should ideally be performed after those of passive mechanics or resting lung volumes since the application of thoraco abdominal pressure or lung inflations may affect respiratory mechanics or FRC 2 2 Tidal breathing Accurate measurement of tidal breathing is fundamental to most infant LFTs Although superficially appearing to be one of the simple
199. often an incomplete tidal breath Although it is not necessary to deselect the last breath in this instance as the breathing pattern was regular this approach may be helpful in other cases 140 6 2 3 Criteria for acceptability no evidence of mask leak Figure 96 and Figure 101 Vr CV is lt 10 where CV is calculated as the mean SD x 100 6 2 4 Reporting results mean values of the main outcomes Figure 99 and Figure 102 are calculated from 20 60 valid breaths VCV and V kg are included in the Result table as quality control indicators Figure 102 section 6 2 3 Table 5 shows examples of average values of tidal volume as well as C and FRC when expressed as a simple ratio of body length or weight at specific ages throughout the first 2 years of life NOTE For tidal breathing with the exception of VTn which indicates total number of valid breaths for each trial and comined number of breaths the first results column although labelled as Best displays the mean values calculated using data from the 2 trials Figure 103 Act2 Act3 Act4 Act5 Figure 103 Summary of tidal breathing parameters Legend A total of 55 valid tidal breaths are analysed and values summarised as mean tabulated in the column labelled Best V7 CV and V kg highlighted in the red circle are listed for quality control purposes Table 5 Examples of average values of tidal volume complian
200. om list see Figure E to read results in Excel worksheet NOTE e The user can either select and open the files to view the lung function with patient data on the CareFusion computer or save the files to a USB pen or portable hard drive and view the data on another computer with Microsoft and or Statistical software 222 e Once the data are downloaded and saved to a storage media the user may then select and transfer the relevant parameters from Excel worksheet to a statistical software package LIMITATION of the export programs a These programs will download or export the entire datasets in the Lab4 DB in numerical format each time an export is performed b Itis not possible to export by selecting for instance a block of data according to test dates or study ID numbers or one single dataset c Following each session of data export the user needs to clean the data by displaying and reading data via Wordpad or Excel software in order to select or delete rows of relevant data according to subject ID and test dates 223 8 11 CareFusion Masterscreen BabyBody Equipment 1 Software programs e Tidal breathing Parameters o Tidal Volume VT o Respiratory Rate RR o Inspired Expired Times ti te o Time to peak flows tPTeF teTEF te e Passive mechanics single and double occlusion techniques o Compliance of the respiratory system Crs o Resistance of the respiratory system R s o Time constant of
201. on the type of putty used it may be helpful to mix a putty of a firmer consistency with one that is softer to achieve the ideal consistency to create an optimal mask seal It is not recommended to use a putty that is too soft and pliable at room temperature since its consistency will soften further during the test duration due to increased temperature body heat Throughout the test duration careful monitoring is necessary to check that the putty has not become too soft which potentially may result in partial blockage of the infant s nostrils or mouth within the mask cavity From time to time gentle re adjustment of the PNT mask may be required during testing However take care to avoid waking the infant The BabyBody Masterscreen system displays 4 windows during data collection data review and analysis Figure 70 illustrates a screen display during assessments of FRCpieth e window A shows a time based recording of flow V volume V changes in box volume Vs during spontaneous breathing and pressure changes at the airway opening P3 and Vg during an airway occlusion e window B displays tidal volume mL against time in seconds e window C shows a table of results and quality control variables both online during the test procedure and also offline when data are reviewed and or reanalysed The variables chosen to be displayed may be customised by the user investigator section 3 4 e window D dis
202. ory effort Since this may potentially overestimate the value of FVC and hence FEV and FEF caution is recommended when deciding whether the FEFV curve should be included or de selected from final calculation of results see Legend for Figure 146 177 WindowB Act 2 v Act 1 N A ee g 5 WindowC ee Act 2a FVC 499 mL Act 2b FVC 524 mL Figure 146 The blip at the end of the RVRTC curve windows A and B may bias FVC measurement and hence calculations of FEV and FEF Legend Window B the RVRTC curve in window A denoted in red i e Act 2 is shown overlaying with the RV curve in grey Act 1 obtained during the same test session FVC for Act 2 could potentially be assessed in 2 ways a when forced expired flow first appeared to reach zero flow indicated by the brown vertical line FVC 499 mL b FVC 524 mL when forced expired flow continued and subsequently crossed over zero flow marked by the dark blue vertical line Note that the RV curve from Act 1 proceeded smoothly to zero flow thus considered a technically acceptable curve with FVC being 494 mL Window C which was similar to FVC for Act 2a 499 mL In order to compare FEV and FEF results based on FVC calculated for Act 2a and Act 2b separately as shown above Act 1 is used as a proxy for Act 2a As can be seen in Window C although results for FEV for Act 1 and Act 2b are comparable the differences between FEF 7 and FEF2s 7
203. ow passive expiration after its release A minimum occlusion time of 400 msec and a maximum occlusion 34 V 1 June 2014 time of 1 5 seconds in which to attain a pressure plateau lasting at least 100 msec has been recommended Results are usually expressed as the mean of three to five valid measurements Valid measurements depend on the following three fundamental assumptions i e that there is complete relaxation of the respiratory system during both the occlusion and the subsequent expiration pressure at the face mask equilibrates rapidly and hence represents alveolar pressure both compliance and resistance remain constant throughout the expiratory phase over the tidal range such that the lung can be treated as a single compartment model with a single value of T s With persistence these conditions can be achieved in the majority of healthy infants during quiet sleep but they are more difficult to satisfy in infants with severe airway disease in whom pressure equilibration may not occur rapidly enough in the presence of severe airway obstruction or a rapid respiratory rate and in whom the respiratory system can rarely be described by a single time constant due to heterogeneous distribution of any airway obstruction or interstitial lung disease It should also be remembered that results from the single occlusion technique reflect the combined mechanics of the entire respiratory system chest wall lungs and airway whic
204. owever due to increased uncertainty regarding reliability of reference ranges for infants and young children and the fact that multiple PFTs are often used in the assessments these limits may be set at 1 96 Z scores to encompass 95 of the healthy 179 population Unlike percent predicted where each outcome has a different threshold for abnormality the same cut off of 1 64 or 1 96 Z scores applies across all pulmonary function indices Z scores are useful for tracking changes in lung function with growth or treatment as they allow comparison of lung function results obtained with different techniques An increasing number of clinical research studies are now reporting infant lung function as Z scores Regardless of whether Z scores or predicted are used to express results the age specific normal range should always be included in the lung function report Particular caution is required when interpreting results that lie close to the somewhat arbitrary cut offs between health and suspected disease especially when results are limited to a single test occasion As with all tests LFTs should be considered as only one part of the whole clinical picture As mentioned earlier marked biases between predicted values can occur due to alterations in equipment and protocol differences in population characteristics the statistical methods applied or simply be caused by sampling error due to too few healthy children being tested
205. pacer Therefore the clinical relevance of a positive BDR for the diagnosis or prediction of asthma as well as predicting a therapeutic response to bronchodilators is currently uncertain and requires longitudinal data 46 V 1 June 2014 3 Setting up an infant lung function laboratory 3 1 3 2 Ambient conditions the room where lung function testing is conducted should have a very stable floor and walls to minimise the effect of vibrations since the infant equipment particularly the plethysmograph is designed to measure pressure signals of very small magnitude and is therefore highly sensitive to any vibrations The plethysmograph must be protected against direct sunlight and moisture a room temperature of 20 25 C should be maintained using a thermal controlled device or air conditioning doors and windows should be kept shut during test procedures to reduce noise and minimise disturbance or fluctuations in ambient pressure particularly during data collection for FRCpleth subdued lighting and quiet ambience should be maintained to encourage the infant to fall and remain asleep Equipment and apparatus 3 2 1 Masterscreen BabyBody Plethysmograph CareFusion Figure 12 CareFusion Masterscreen BabyBody Plethysmograph Customers may purchase a Masterscreen system Figure 12 comprising different components according to their requirement for instance tidal breathing and passive mechanics package with or wit
206. part A and or part B of the support arm to achieve an optimal position so that the mask PNT may be best fitted over the infant s nose and mouth taking care not to press too hard over the bridge of the nose this will increase upper airway resistance or depress the chin In practice the safest way for the user to re apply or adjust the placement of the PNT mask while it is already secured on the infant s face is to position the back of his her left wrist beneath the 2 part support arm and simultaneously with the same left hand hold the PTN mask firmly while using the right hand to unlock the rotary knob anti clockwise an assistant could then hold the 2 part support arm firmly and gently place a hand over the infant s forehead for additional protection while the user loosens the putty from the face all round the rim of the mask to ease the removal of the mask PNT gently away from the face or re position the mask Once the best fit of the mask PNT has been obtained rotate the knob clockwise to tighten the locking mechanism but not so tightly that it cannot be loosened quickly should the infant wake unexpectedly such that no weight is directly exerted over the infant s face The user can now adjust the putty that is around the rim of the mask to create a leak free seal 104 V 1 June 2014 Figure 68 Illustration showing some parts of the Babybody system including the control panel and 2 part support bar for the PNT As soon a
207. pect to breath selection i e adjust setting to deselect the upper and lower 5 or 10 of data and graphic screen display of variables such as tprer te and Vper Vex mean results reported by the program are calculated only from the valid values 139 only individual breaths with valid tprer te and Vper Vex are used in the construction of curve averaging Figure 100 and Figure 101 e data can be viewed in 2 ways as illustrated in Figure 101 to toggle between the screen displays click on the small graphic symbol at the top right hand corner red circle upper left window Figure 101 E i Figure 101 Off line analysis of tidal breathing parameter Legend Data can be viewed as flow versus time left panel upper left window and flow and volume time base trace right panel upper left window Clicking on the small symbol circle in red allows the user to toggle between the display modes Figure 102 Note coefficient of variability CV of tidal breathing data Legend The recommended coefficient variability of V should be lt 10 of V Window A shows that Act 2 comprised 30 breaths with V CV of 9 51 which is within 10 of mean V However in this example when the last tidal breath from the same Act is deselected open square symbol window B value of V CV improved 2 94 while other parameters remain similar The improvement in the V CV may be because the first or the last breath is
208. plays the phase relationship between changes in Pao kPa and changes in Vz mL for each respiratory effort during the period of the airway occlusion In this example 3 complete respiratory cycles were recorded while the shutter balloon was inflated effecting an airway occlusion windows A and D Following balloon deflation a spontaneous sigh like big breath was observed followed by regular tidal breathing window A 106 V 1 June 2014 Program Settings Messung system Es5y5ody 5 Shutter balloon test Medication none 2 Best FRCp 1607 1607 result table Figure 70 The screen display for FRCpieth data and results 5 2 Measurements of tidal breathing TB parameters In general measurements of TB parameters are recorded with the plethysmograph opened However if FRCp eth is part of the data collection protocol then the plethysmograph may be closed during recording of TB parameters This facilitates stabilisation thermal equilibration of the plethysmograph thus reducing the subsequent waiting time after switching to the plethysmography program once TB collection is completed e The process of setting or reviewing the sample frequency and contents of result table has been described in section 3 4 7 e Check that all program settings are correct section 3 4 7 e Alist of Function keys are available in Appendix section 8 3 5 2 1 Application of face mask and PNT e The mask PNT unit is carefully and ge
209. pleasant taste in the mouth vomiting drowsiness agitation and disorientation Allergic reactions slow heart tate and shallow breathing have been observed As a precaution your child must not be fed within two hours before the test and we will monitor your child s oxygen levels and heart rate during the test In the rare circumstance that your child develops any side effects we may give oxygen through a mask a medication against allergy and or observe your child for an extended period of time on the ward After the test your child may be drowsy or unsteady for a couple of hours Your child should not be left unattended and watched carefully on the day of the test We and others have used chloral hydrate for nearly 20 years and in that time have performed lung function tests on thousands of infants We have the experience to say that these tests and the sedative are safe in infants 197 8 5 Example ofa Consent form for a research study Great Ormond Street Hospital for Children NHS Trust amp Institute of Child Health Research Ethics Committee REC Number 09H071314 Consent Form for PARENTS OR GUARDIANS of Children Participating in Research Studies Early detection of lung disease in infants with Cystic Fibrosis diagnosed by newborn screening NOTES FOR PARENTS OR GUARDIANS 1 Your child has been asked to take part in a research study The person organising that study is responsible for explaining the project to you before
210. prematurity on infant pulmonary function Pediatr Pulmonol 2014 49 679 687 Nguyen TT Thia LP Hoo AF et al Evolution of lung function during the first year of life in newborn screened cystic fibrosis infants Thorax 2013 Sep 26 doi 10 1136 thoraxjnl 2013 204023 Epub ahead of print Hoo AF Thia L Nguyen TD et a Lung function is abnormal in 3 month old infants with cystic fibrosis diagnosed by newborn screening Thorax 2012 67 874 881 Borrego LM Stocks J Leiria Pinto P et a Lung function and clinical risk factors for asthma in infants and young children with recurrent wheeze Thorax 2009 64 3 203 209 Stocks J Coates AL Bush A Lung function in infants and young children with chronic lung disease of infancy The next steps Pediatr Pulmonol 2007 42 1 3 9 Lum S Gustafsson P Ljungberg H et al Early detection of cystic fibrosis lung disease multiple breath washout vs raised volume tests Thorax 2007 62 341 347 Lum S Hulskamp G Merkus P et a Lung function tests in neonates and infants with chronic lung disease forced expiratory maneuvers Pediatr Pulmonol 2006 41 3 199 214 Hulskamp G Pillow JJ Dinger J et a Lung function tests in neonates and infants with chronic lung disease of infancy functional residual capacity Pediatr Pulmonol 2006 41 1 1 22 Gappa M Pillow JJ Allen J et al Lung function tests in neonates and infants with chronic lung disease Lung and chest wall mechanics Pediatr Pulmonol 2006 4
211. propriate for data collected using the Carefusion equipment application of an adjustment factor may minimise errors in the interpretation of RVRTC data Age and length contributed equally and significantly to these models After adjusting for length or age addition of the other variable did not add significantly to the model and length was chosen in preference to age to prevent any bias due to restricted growth when applying such equations to children with lung disease 182 6 8 Data back up storage and export Apart from being able to retrieve lung function data from the BabyBody LabMan relational database to review and analyse data the Merge function software Figure 147 enables the following Figure 147 The red circle in the right upper quadrant indicates the Merge function icon 3 frequent backing up of the BabyBody LabMan database by exporting data to a storage media e g a portable hard drive or server to ensure protection safety of the data collected over time 4 data may be exported periodically from the database in electronic format and displayed in Microsoft Notepad or Excel format for data checking or cleaning prior to transferring to statistical packages e g SPSS IBM software for analysis 5 once the CareFusion infant data are merged out the exported data may be saved and stored to a different format such as in Microsoft Excel worksheets from which the users can transfer or import thes
212. r x Trigger mode C Manual instantaneous Figure 35 The synchronized option is the preferred mode for the jacket inflation mechanism 3 4 8 6 Setting safety criteria for tidal squeeze manoeuvre e To check edit safety criteria go to the menu bar click on Program gt Modify settings return to the menu bar select Settings gt warnings Minute ventilation Warning threshold No signal warning delay Jacket pressure warning threshold Occlusion warning threshold Settings Warnings x fp s Cancel 02 kPa o2z kPa Default Figure 36 The recommended default settings for safety alerts during tidal RTC manoeuvres e Figure 36 shows the recommended default settings for safety alerts during the partial forced expiratory manoeuvres Whenever concerns regarding the infant s breathing pattern or the apparatus are detected warning messages will be displayed in the monitor window 69 V 1 June 2014 Minute ventilation a relatively low threshold is set so that an immediate warning is displayed if the infant s minute ventilation drops this may also indicate that a mask leak is present No signal warning delay if a flow signal is not detected a warning message is displayed after the duration of time set as default Jacket pressure warning threshold a low threshold e g 0 2 kPa is set to ensure that if a rise in P is detected at times when jacket inflatio
213. rection upper left window Legend Invalid breaths are displayed as blank symbols lower right graphic window the valid breaths solid blue symbols are used for analysis and to construct the curve averaging lower left window To review each dataset click on F2 Calculate and display trial results or F7 Display of final results Figure 75 NOTE the expected range for tidal volume adjusted for body weight V kg is 7 14 mL kg If values are lt 5 6 mL kg a mask leak is likely to be present although a normal V kg does not necessarily exclude a mask leak e g an erroneously low weight entered for the infant If necessary click on F1 to continue data recording Once sufficient satisfactory data have been collected click on F10 Save data and exit program alternatively click on F9 New start of complete measurement follow instruction on the screen when prompted Save measurement Figure 76 Click on the Yes button to save data to database otherwise all data recorded thus far will be deleted A new test or trial will commence once the operator has clicked on Yes or No button In all instances once sufficient data have been collected click on F10 to save and exit program 111 V 1 June 2014 Act2 Act Act4 Act5 only mean vahe Now test v Curves F Trend of parameters Seltest Last Test 7 Flow vebume loop v Retoadable data 10 8610 1 160180
214. renennes 63 Contents Of FRCpleth result tablei iiini eee esecseeeseecsneceaeceaeceaeeeseeeeeeeeeeseaeseaeeeaeeeaaeeaaes 64 Tidal RTC program Settings cccccesscccceccescssssnsesececeeecesseseeaeseceesesseessseaeeeeees 65 Sampling frequency for tidal RTC cccesscccccceesessssaececeeeeessnseeaeeeeeesseesesnsaeeeesesseenea 65 V 1 June 2014 3 4 8 2 Setting measurement criteria for tidal RTC MANOCUVIES c ccccccceeessessseeeeeeeeesees 65 3 4 8 3 Setting quality control criteria for tidal RTC manoeuvres cccccccseessessseeeeeeesessees 66 3 4 8 4 Setting the reservoir pressures for tidal squeeze MANOCUVIES cccceseesssteeeeeeeseseees 67 3 4 8 5 Setting criteria for the tidal RTC occlusion ccceessceceeecesseseaeceeeeseessesteaeeeeeeeseesees 68 3 4 8 6 Setting safety criteria for tidal squeeze manoeuvre ececeseessstececeeeceesenteaeeeeeessesses 69 3 4 8 7 Setting criteria for assessment of jacket tranSMiSSiON ccccccccceceeessessseeeeeesseesees 70 3 4 8 8 Contents of tidal RTC result table eee eeesceceeceeceeeeeesaeeeeaaeceeeeeseaeeeesaeeneaaeseeees 71 3 4 9 Raised volume RTC program settings cccccccssssssscececeeecsesssseeeeeeeesesssessnaees 72 3 4 9 1 Sampling frequency for Raised Volume RTC cscsssccececessessneseceessessesssaeeeeeesseeenes 72 3 4 9 2 Setting the measurement criteria for Raised Volume RTC mManoeuvreS cceeee 72 3 4 9 3 Setting the
215. ress syndrome REM rapid eye movement RR respiratory rate min 20 V 1 June 2014 Abbreviation Symbol Description Unit Res resistance of the total respiratory system kPa L s RTC rapid thoraco abdominal compression RVRTC raised volume RTC RV residual volume mL L SO SOT single occlusion technique SRaw specific airway resistance Raw multiplied by FRCpieth kPa s SReff specific effective airway resistance Reg multiplied by FRCpietn kPa s sS seconds SpO pulsatile oxygen saturation T tau time constant S Ta time constant of the respiratory system s t time min s te expiratory time S ti inspiratory time S tpTEF time taken to reach peak tidal expiratory flow S tprerite ratio of the time taken to reach peak tidal expiratory flow in relation to total expiratory time TLC total lung capacity mL V flow mL s V volume mL Vs OF Vbox plethysmographic box volume AVbox change in box or plethysmographic volume mL Vex total expired volume mL Vinf inflation volume mL VpEF expired volume up to tidal peak flow mL Vr tidal volume mL Z score standard deviation SD score A delta Change in 21 V 1 June 2014 Commonly used conversion factors in infant LFT Pressure 1 cmH 0 0 098 kPa Pressure 1 mmHg 0 133 kPa Compliance 1 mL cmH O 10 2 mL kPa Resistance 1cmH O L s 0 098 kPa L s Glossary of terms Term Definition Coefficient of variability CV standard deviation mean x 100 Compl
216. rial LFTs can be performed potentially limiting their clinical usefulness in individual infants Given the limited period of sleep that may be induced by sedative agents such as chloral hydrate important decisions need to be made regarding which tests should be prioritised on any given occasion according to either the suspected underlying pathophysiology or research question Certain tests such as plethysmographic lung volumes should be performed prior to those involving forced expiration 1 4 Which infants can be tested e In general it is recommended that all babies are tested when clinically stable and asymptomatic testing is deferred for several weeks after any respiratory infection or exacerbation see section 4 1 1 e Any evidence of upper airway obstruction represents a high risk situation where sedation is contraindicated Acute wheezing or symptoms following chronic lung disease of prematurity may also put the child at increased risk Details of risk assessment and safety measures that are essential in every infant LFT lab are summarised in section 4 4 e Reference equations with which to interpret results obtained using the CareFusion BabyBody device are only available for white full term infants of European descent 26 V 1 June 2014 between 3 105 weeks of age There is some evidence that results may differ in infants of other ethnic origins e Plethysmographic assessments of FRC have not been validated in infants lt
217. rmly in place sealing the opening for the RTC large bore tubing Figure 60 i e no leak to the body plethysmograph Figure 60 Ensure that the rubber stopper is firmly in place prior to box calibration e Lower the hood to close the box with care e Select and click on Box Calibration to open program Figure 61 LabManager V4 67a New test Figure 61 Box calibration icon indicated by the red circle e Follow the instruction on screen and allow 2 3 minutes for the box to stabilise Figure 62 89 V 1 June 2014 Please wait 2 3 minutes tor the stabilizabon of the box 136 Cancel oz Box volume 98 L 98 Figure 62 A send of 2 3 minutes are required for the closed box to stabilise e Box calibration program will automatically proceed once the 2 minute waiting time has elapsed e three trials of box calibration will be activated automatically and results displayed graphically and numerically Figure 63 Figure 63 Box calibration examples of ecataed trials of half life time constant in seconds Legend Left panel satisfactory box calibration with a median tof 8 7 s Right panel presence of a siginificant box leak during calibration median t 3 6s e The process of calibration involves the assessment of the time constant of the box i e the time it takes for a change in the box signal to decay to
218. rosis Family history of asthma and atopy Ethnicity Factors that may influence lung function data 98 V 1 June 2014 prior history of surgery involving the respiratory system prior history of respiratory illness treatment medications passive exposure to cigarette smoke 4 3 3 2 Lung function summary sheet This one page at a glance summary sheet is completed on each test occasion section 8 8 Information recorded includes weight and length at time of test outcome of clinical examination vital signs readings pre sedation and during test duration type and amount of sedation given route administered arousal state condition of infant prior to leaving the Lab 4 4 Sedation Although it is possible to assess some aspects of lung function in young infants during natural sleep following a feed it is difficult to perform more complex tests such as plethysmographic lung volume and forced expiratory manoeuvres in infants greater than 44 weeks post menstrual age without some form of sedation A single dose of chloral hydrate or the derivative triclofos sodium elixir sections 1 3 2 and 4 4 3 is usually required to induce 30 45 minutes of sleep to facilitate lung function data collection It is advisable to schedule the test to coincide with the time when a daytime nap is expected 4 4 1 Contra indications for sedation A careful assessment with detailed history and a clinical exam
219. s ventilation is adequate Cardiovascular function is usually maintained 4 4 6 Handling of infant following of sedation Being able to obtain satisfactory data depends on careful handling and minimal disturbance to the infant Once he she has been weighed and clinical examination completed the infant should be dressed in light and loose fitting clothing to avoid restriction to chest movements check and remove any solid or hard items e g zippers necklaces belts buttons to ensure these are not between the jacket bladder and the infant s chest abdomen which may cause discomfort during RTC manoeuvres e Check and document baseline SpO heart rate and respiratory frequency prior to administering chloral hydrate sedation e Dim lighting and noise reduction to encourage sleep e Maintain room temperature between 20 25 C in order to avoid body cooling particularly when studying young infants especially those who are preterm achange in cardiorespiratory activity that is associated with small increase in body temperature as soon as the infant has fallen asleep 102 V 1 June 2014 immediately commence continuous monitoring of SpO heart rate and respiratory frequency minimal and gentle handling keep noise level to minimum constantly observe the infant s behavioural and sleep patterns e Never leave the infant unattended 4 4 7 Classification of sleep state Data recording
220. s the infant falls asleep the pulse oximeter is attached preferably to the left foot and continuous vital signs SpO and heart rate are monitored The infant is placed in the standard supine position in the BabyBody carry tray With a neck roll and small pads pillows the neck is extended and shoulders supported Figure 69 wn Figure 69 A face mask connected to the PNT is applied over the nose and mouth of a 2 month old sleeping infant left and a 1 year old infant right While the infant is in quiet non rapid eye movement non REM sleep the face mask lined with putty around the rim is applied over the nose and mouth Figure 69 Gently press down around the rim of putty to create an air tight seal with the face before commencing data collection Throughout the data collection period observe the infant s sleep state and vital sign recording If the infant is observed to be in REM or active sleep data collection should be terminated and 105 V 1 June 2014 the session recommenced when the infant returns to non REM quiet sleep Similarly if the respiratory pattern becomes irregular data collection should stop and restart when regular respiratory pattern resumes Continue to observe that the infant s respiratory efforts is normal and that optimal oxygen saturations are maintained at all times remove the face mask immediately if upper airways patency is potentially adversely affected NOTE depending
221. s to C and Rs therefore only the SO technique will be discussed below 3 4 4 1 Sampling frequency for passive respiratory mechanics e Double click on Baby Res Compliance to open program Figure 18 e The sampling speed for this program is set automatically to 100 Hz NOTE It should be recognised that when using a higher sampling speed the duration available for each epoch or trial is shortened for data collection However using a low sampling frequency may lead to loss of signal fidelity such as signal clipping or non linear distortion of recorded signals Frey 2002 ERJ section 7 3 In general it is recommended to set sampling rate at a higher frequency than the minimum acceptable rate to allow for different measurement conditions during the testing procedure e g during a Squeeze manoeuvre although tidal breathing is recorded initially to ensure a stable end expiratory baseline this is subsequently followed by a forced expiration when flows will be considerably higher 59 V 1 June 2014 3 4 5 Setting technical criteria for single occlusion test SOT e To access the Settings menu click on Program from the menu bar gt Modify click on Settings from the menu bar gt Settings e Figure 25 shows the Settings Occlusion menu which illustrates the timing and duration of the shutter balloon for the SOT and technical criteria for identifying an acceptable pressure plateau at the airway ope
222. sa an Mes please give details Note all symptoms of cough or wheeze should be considered CF related and should not be recorded here Hospital ad missions since birth the following information is required for each Date of admission r son for admission hospital name date of dischars whether in patiant treatment r a respiratory infection included VY antibiotics Duration and type of any ventilation Ea ie ee a szed az chest SS SS Ss ee es ee E a E pete anaes a tea 209 b Information from parent at subsequent visit page 3 of 4 Study mmber BBE Test occasion 0 Whether the child has had bronchiolitis since last LFI Has your child bad a cold in the last 3 weeks Yes bot asymptomatic for days Yes and soll symptomatic 210 b Information from parent at subsequent visit page 4 of 4 Study number 5 3 Test occasion 0 Date IITTI How often has your child coughed and has he she wheezed in the last 7 days Cough None With physia only Not just with phxin bat not daily Dally Wheeze Physiotherapy gixen notatal onea day C times a day No of hours since last physio session A brs Does mother smoke now No Yes cigarettes a day Does mother s partner smoke now No Yes cigarettes 2 day Number of smokers living in the same house as the infant including mother __ smoker s Child Regularly exposed to non household smoling Exposure to any other cigarette smoke in the past 24hrs If y
223. sai eoria ra EEEE Ope TVENNE EKER UKENE EESE i cee 151 Criteria for acceptability ves cesasezccceeins sevice E He deck eee T i a 151 Dat OVATION ane aat ee at aae aaae AA AAAA ai 152 Examples of invalid trials cccccsssssscececeeecsesesseseeeceeeesceesseaeeeeeeseessessaaees 156 Reporting PeSUltS evi cserceee esi eadivel E ee le ees eve 161 Analysis and reporting of tidal RTC data cccccccccssssssscsececessesssseseeeescessessnteaeeeesens 162 Main OUTCOME Srii coliskeccocscucecacdekcccecauues celasuceceusenescagdenedcevacy 162 Criteria for acceptability cees seereniai etinin en ieri aa aa 162 Dat va luati n sisrccutecs tatacets aie eiai a a A E a E i 162 Examples of invalid trials sseessesessnssssssesssererssereesrssresnssrrerssrerenseerensesrnnnssens 165 Transmission of jacket pressure Pj sssssssesesssesrsesrrsrsrsresrsreriresrnresrnrnrrersrnensese 168 Reporting res lts uerrini i E E A Bestel E AE AEE 169 Analysis and reporting of Raised Volume RTC data ccccccscsssssceceeecessesscteaeeeesens 170 MaliiOULCOMES oc bccecceecd then ceadeeth a ceetea te ett a a auediateatetues 170 Criteria tor acceptability seneni e an a A aa Aa aaa ia ih 171 Data evaluatie nenn cade aden ARA EEA leeks 171 Examples of inyvaliditrial Sone sannana aa a A A Sas 173 R portingres lts airea a ai a a a Eaa 178 Interpreting results the role of reference equations sessssssssssssssrssssesererrrssesesee 179 Reference equat
224. see recommended reading list section 7 and are only summarised below The following sections provide basic essential background and physiology relating to infant lung function testing experienced individuals who are familiar with these may wish to move on to section 3 1 2 Developmental changes which may impact on assessments 1 2 1 Background When undertaking infant LFTs a basic understanding of developmental physiology is essential For example in contrast to adults the vagally mediated Hering Breuer inflation reflex HBR is physiologically active over the tidal range during the first year of life Tonic and phasic vagal stretch receptors in the lungs and airways are exquisitely sensitive to changes in resting lung volume and as discussed below infants modulate both expiratory time and flow during the first months of life to maintain an adequate resting lung volume i e functional residual capacity FRC While this ability to modulate resting lung volume dynamically may be physiologically beneficial to the infant it can complicate attempts to assess respiratory function especially those outcomes that are dependent on a stable end expiratory level EEL Thus while the active HBR allows assessment of passive respiratory mechanics section 2 3 2 in infants during tidal breathing in a way that is not feasible in older subjects the associated variability of EEL may impede assessment and interpretation not only of resting lung volumes
225. sessing infants than when testing older subjects For further information see section 3 and Appendix 8 1 for details of equipment and suppliers and section 7 for recommended reading list 1 6 Leaks and dead space An oro nasal mask is generally required when undertaking infant LFTs This may significantly increase equipment dead space with subsequent increases in tidal volume VT and potential elevation of the end expiratory level Air leakage around the face mask are a common source of error but can be difficult to identify and will invalidate all measurements Therapeutic putty may be used to create an airtight seal between the face and the mask and minimise dead space 27 V 1 June 2014 although some investigators prefer to use an air filled cushioned mask particularly in very young and unsedated infants Whatever the approach operators must be vigilant at all times to avoid the serious errors caused by air leakage Warning signs include low V drift of the V signal or failure of the EEL to return to baseline after a brief airway occlusion see section 5 2 2 for details 28 V 1 June 2014 2 Brief Theoretical Background to Selected infant LFTs 2 1 Introduction Which test when The choice of which test or combination of tests to undertake must be guided not only by the clinical condition or specific research question being investigated but also by the expertise of the operators Those less familiar with the undertaking
226. should be confined to consecutive periods of quiet non rapid eye movement non REM stage 1 sleep Classical behavioural criteria Table 4 established by Prechtl in 1974 section 7 2 are used to assess sleep state at one minute intervals with quiet sleep being determined by the absence of eye movements relaxed and stable posture with regular breathing Table 4 Sleep state classification Criteria Quiet sleep Active sleep Rapid and or slow eye movements None Present Facial grimaces None Present Respiration Regular Irregular Body movements relaxed stable posture frequent Startles Occasionally Frequent 103 5 V 1 June 2014 Infant lung function data collection 5 1 Apparatus safety issues 5 1 1 PNT support bar Before attempting to apply the PNT and face mask to an infant the user must become familiar with the function of the 2 part support bar that carries the pressure sensor for the PNT Figure 68 The support bar and hence the PNT and mask can be locked into position by tightening the locking mechanism by turning the rotating knob once its appropriate position has been ascertained The underside of the support bar must always be supported before loosening the locking mechanism in order to avoid any possibility of the support bar with the PNT and mask falling onto the infant s face The locking mechanism held from the underside by the user can be partially loosened to allow movement and adjustment of
227. sit page 4 of 4 Study number sist 4d Test occasion 01 Date TTL Number of smokers living in the same house as the infant including mother _ smoker s Child Regularly exposed to non household smoking Exposure to any other cigarette smoke in the past 24hrs If yes Who Has urine been collected Has saliva been collected Date and result of CXR 207 b Information from parent at subsequent visit page 1 of 4 Study num ber is 3 Test occasion 0 Date ITIITI Questionnaire for GOSH CF Referral Baby s mame DateorBirts TTT 111 Timeofarrivalattetsie Cr CC E eral chloral sedation Yes No Time of administration of sedation SSS Timeo SCS J Time oftest commencement SSCS Time ofleaving testsite SSS C A Number of sleep epochs required to compleetste f aaminin atte oft Yes No Crackles sao sao _rv Anthropometry Weemt Crown heel length C a orc _ cm pH study performed If Yes date amp result since previous visit 208 b Information from parent at subsequent visit page 2 of 4 Study num ber is 3 Test occasion 0 BAL performed since previous visit Date and result of CXR anaiak jop CE E Whether the child has any atopic disorder Whether a doctor has ever diagnosed asthma Whether the child has developed eczema Whether the child has developed hay fever cco am _ fe ide esa nes
228. size 0 1 2 Supplied by Carefusion when purchasing Masterscreen BabyBody System Also available via http www intersurgical co uk products reprocessable anaesthetic masks rendell baker silicone masks Balloon shutters CareFusion UK Global Squeeze jackets small medium large bladders and large bore tubing Supplied by Carefusion when purchasing Masterscreen BabyBody System Neopuff Infant Resuscitator with T piece tubing Fisher Paykel Healthcare http www fphcare com products neopuff infant resuscitator Straight connector 15M 15M for the Neopuff T piece tubing http www intersurgical co uk products connectors 15mm straight connectors Therapy putty Patterson medical https www pattersonmedical co uk app aspx cmd get item amp id 1216 Harpenden Infant Measuring Table http www anthropometer com inf ph Seca weighing scales http www seca com en_us products all products html category 23 Terralin disinfectant products terralin protect a cleaner and disinfectant for surfaces and medical devices http www schulke co uk product _ 43 terralin protect 193 8 2 CareFusion s guidelines for Sterilisation and Disinfection CareFusion Sterilization and Disinfection Information It is recommended that the general guidelines below be followed not only for disinfection and sterilization but also to maintain the quality of your instrument Improper cleaning can result in your system becomi
229. smitting approximately 1 0 to 1 5 kPa to the pleural space The P is subsequently increased in increments of 0 5 to 1 0 kPa until further increases do not elicit any further increase in forced expired flow at FRC The optimal reservoir or jacket pressure varies considerably from child to child generally between 2 0 to 8 0 kPa depending not only on jacket efficiency but also on the underlying respiratory mechanics Far lower jacket pressures are required to achieve flow limitation in infants with airway disease than healthy subjects It is advisable to check intermittently the changes in Pao during RTC i e transmission of jacket pressure section 5 5 3 and section 6 5 5 particularly when using high jacket pressures Pj in healthy infants maximum AP during RTC should not exceed 3 kPa Measurements are repeated until 3 technically acceptable and reproducible manoeuvres have been obtained at optimal jacket pressure Since minor fluctuations in EEL can have marked effects on V maxerc it is recommended that V maxerc be reported as the mean of the three highest technically acceptable results Measures of forced flow and volume reflect the integrated output of lung and airway mechanics and as such cannot be used to locate airway obstruction at any particular airway generation or anatomic location Nevertheless since V maxerc is measured at low lung volumes it is believed to reflect primarily airway calibre upstream i e dist
230. sortment of face masks up to but not including any space occupied by the pneumotach as assessed by water displacement when empty and after lining each mask with a rim of therapy putty as would be used during testing effective dead space Table 1 Summary of face mask dead space Rendell Baker Total dead space Effective dead Suitable for Soucek by water space by water infants face masks displacement mL displacement mL weighing Size 0 10 5 2 4 kg Size 1 15 7 5 4 6 kg Size 2 20 10 6 15 kg 3 2 3 2 Therapeutic putty The putty is used to line and cushion the rim of face mask to facilitate an air tight seal when applied over the nose and mouth Selection of a suitable consistency is vital to ensure that the putty can be easily moulded to achieve a good seal but does not become so runny when warmed during use that it seeps towards the infant s nose mouth or eyes see Appendix for supplier 3 2 3 3 Balloon shutters These are available from the manufacturer see Appendix for supplier section 8 1 and are necessary to effect airway occlusions during data collection for passive respiratory mechanics plethysmographic FRC partial and raised volume forced expiratory flow volume curves 3 2 4 Additional accessories when undertaking forced expiratory manoeuvres 3 2 4 1 RTC jacket and bladder The jacket including the inflatable inner bladder should cover as much of the chest and upper abdomen as possible 5 5 1
231. ss such as respiratory syncytial virus infection can trigger an increase in the frequency and duration of apnoea during sleep Healthcare professionals delivering sedation and care for the infant should have e knowledge of assessment of infants e basic and or advanced life support skills e training and practical experience in effective delivery technique of the chosen sedation and monitoring sedative effect e understanding of sedation drug pharmacology and applied physiology e competency in observing clinical signs such as airway patency breathing rate and depth pulse pallor and cyanosis and depth of sedation e ability to monitor identify and respond to complications with immediate management including paediatric life support and recovery care During sedation and throughout the lung function test procedure there must be immediate access to resuscitation and monitoring equipment 4 4 3 Sedation dosage Both chloral hydrate and triclofos sodium are metabolised to trichloroethanol the former has an unpleasant taste and may cause gastric irritation triclofos is more palatable but is slower and less potent 660 mg chloral hydrate is pharmacologically equivalent 1 g triclofos Vomiting respiratory complications and paradoxical reactions may occasionally occur The dosage 100 V 1 June 2014 prescribed is dependent upon the infant s age and condition and may be given orally or rectally The standard dose of chloral hydr
232. ss using ILFTs e Goldstein AB Castille RG Davis SD et a Bronchodilator responsiveness in normal infants and young children Am J Respir Crit Care Med 2001 164 447 454 e Debley J Stanojevic S Filbrun AG et al Bronchodilator responsiveness in wheezy infants and toddlers is not associated with asthma risk factors Pediatr Pulmonol 2012 47 5 421 428 7 9 Examples of epidemiological research applications 7 9 1 Reviews e Harding R Maritz G Maternal and fetal origins of lung disease in adulthood Semin Fetal Neonatal Med 2012 17 67 72 e Greenough A Long term respiratory outcomes of very premature birth lt 32 weeks Semin Fetal Neonatal Med 2012 17 73 76 e Jones M Effect of preterm birth on airway function and lung growth Paediatr Respir Rev 2009 10 Suppl 1 9 11 e Stocks J Late lung disease in bronchopulmonary dysplasis lessons learned from lung function testing Eur Paediatr 2008 2 31 34 e Stocks J Coates A Bush A Lung function in infants and young children with chronic lung disease of infancy The next steps Pediatr Pulmonol 2007 42 3 9 7 9 2 Wheeze e Pike KC Rose Zerilli MJ Osvald EC et al The relationship between infant lung function and the risk of wheeze in the preschool years Pediatr Pulmonol 2011 46 75 82 e Borrego LM Stocks J Leiria Pinto P et a Lung function and clinical risk factors for asthma in infants and young children with recurrent wheeze Thorax 64 3 203 9 2009 e
233. ssion RVRTC technique Figure 11 Figure 89 Figure 90 The RVRTC allows the infant s lungs to be inflated toward TLC before rapid inflation of the jacket initiates forced expiration from this elevated lung volume with the manoeuvre ending when the infant reaches residual volume RV Figure 11 Application of 3 5 augmented breaths using medical air to induce a respiratory pause before forcing expiration generally overcomes the problem of infants inspiring before full expiration to RV has been achieved 41 V 1 June 2014 Flow 25cm H0 Jacket Jacket pressure inflation 25 cm H20 t A Time based trace 900 P C Forced expiration Pa 600 300 P A Passive expiration Flow mL sec Pl B Inflate jacket at end inspiration 300 200 150 100 50 o 50 Volume mL B Fiow volume curve Figure 11 Forced expiratory manoeuvres using the raised volume technique Legend A Time based trace after an initial period of tidal breathing a pre set standardised intermittent positive pressure of 30 cmH 0O is applied at the airway opening to inflate the lungs toward total lung capacity In this example the jacket is inflated at the end of the sixth augmented breath to force expiration from increased lung volume B Flow volume curve obtained during passive and forced expiration from increased lung volume As with most infant lung function tests the clinical utility of the RVRTC technique within individual infants
234. ssion line Min correlation coefficient ps Single occlusion Start regression line Vol A 5s BY zrem vol Stop regression line Vol B fy rem vol Regression line Double occlusion Start regression line Vol A Eo g Stop regression line olZB EB em vot Resistance I Correct system resistance System resistance poss H IkPas Additional resistance filters etc po G IkPas Figure 26 Settings for the regression line for the SO data analysis Legend The regression line is set to emcompass 50 of the linear expiratory portion the minimal acceptable correlation coefficient for the slope from which 1 is calculated 3 4 6 Contents of passive mechanics result table To review and or edit Figure 27 the list of variables displayed in the results table e Go to menu bar click on Program gt Modify settings Return to the menu bar click on Settings gt modify gt Parameter list gt Contents of Table e Browse through the list of variables and select relevant ones for display Figure 27 e Click on the Accept button to save contents and OK to exit 61 V 1 June 2014 m Pred Best Actl Act2 Act3 Act4 Act5 Vokmefmi Flow mnl s Nila i _xtdct T EPrea zaai Baf E F Auto text F Long form Text P ed Figure 27 Variables selected for online display in the result window top right Legend values of C and R are reported whereas weight adjusted tidal volume V the volum
235. ssment these limits may be set at 1 96 Z scores to encompass 95 of the healthy population Z scores are useful for tracking changes in 44 V 1 June 2014 lung function with growth or treatment as they allow comparison of lung function results obtained with different techniques They can be converted into percentiles 1 96 to 1 96 Z scores are equivalent to 3 to 97 percentiles respectively which is easier for parents to grasp Particular caution is required when interpreting results that lie close to the somewhat arbitrary cut offs between health and suspected disease especially when results are limited to a single test occasion As with all tests LFTs should be seen as only one part of the whole clinical picture When selecting reference data with which to interpret clinical lung function results from an infant or young child it is essential to ensure that the selected reference equations are appropriate for the age and body size of the individual being studied and that they were derived using appropriate statistical techniques from a large number of healthy infants at least 100 who were studied using identical techniques and equipment The need for sedation and the duration of tests have limited the number of healthy infants who can be studied at any one centre While international collaborative efforts led to the publication of sex specific reference data for V maxrrc during infancy that proved appropriate at the time
236. st investigations to undertake such measurements and their interpretation are in fact highly complex Patterns of tidal flow volume loops can yield potentially important information about the likely site of obstruction Figure 77 Peripheral airway narrowing generally produces a concave pattern of the expiratory flow volume loop with peak tidal flow occurring early in expiration This pattern probably reflects a reduction in post inspiratory diaphragmatic activity or laryngeal braking in the presence of a prolonged t due to elevated airway resistance Flattening of the expiratory limb is suggestive of a fixed extra thoracic airway obstruction whereas marked convexity of the volume axis may reflect physiologic braking of expiratory flow A pattern of inspiratory fluttering may be associated with laryngo malacia whereas stiff lungs low compliance and high elastic recoil may be reflected by a relatively small Vz with high peak flow and rapid lung 29 V 1 June 2014 emptying However considerable caution is required when interpreting such loops due to marked natural physiologic variability within and between children particularly during early infancy Expiration Inspiration Expiration D Inspiration Figure 2 Patterns of tidal flow volume loops Legend A normal B flow limitation or airway obstruction C laryngeal braking or fixed intra thoracic obstruction D fixed extra thoracic obstruction E reduced complia
237. st of variables and select relevant ones for display Figure 38 Click on the Accept button to save contents and OK to exit Type of table Contents of table Properties Column Selected wa ot Free 273 CE Acs fAct2 ct3 a Formulas Pred Aai E _Best _PredLL _PredUL xtc E Prea zaai Eca E V Auto text IV Long form Text Be Figure 38 Selected tidal RTC variables for display in the result window 71 V 1 June 2014 3 4 9 Raised volume RTC program settings e From the LabManager main group page open the program by double clicking on Raised Volume RTC icon Figure 18 3 4 9 1 Sampling frequency for Raised Volume RTC Similar to the Tidal RTC test the Raised Volume RTC is also programmed to automatically data collect at the minimal acceptable sampling speed of 200 Hz 3 4 9 2 Setting the measurement criteria for Raised Volume RTC manoeuvres e The process of setting up the measurement criteria for the Raised Volume RTC manoeuvres is the same as for tidal RTC trials see section 3 4 8 e Figure 39 shows the measurement settings for Raised Volume RTC which are largely similar to those set for tidal RTC manoeuvres the only difference being a slightly longer duration i e 3 s selected for Max compression time e In older infants young children and those with airway obstruction the default setting for Max compression time may need to be longer than 3 s to ensure complete exhalation RVRTC
238. t the manner in which the research is conducted it may be given to the researcher or if an independent person is preferred to Dr Nicole Gerrand Manager Research Ethics and Governance HNEHREC Locked Bag 1 New Lambton NSW 2305 telephone 02 4921 4950 Email nicole gerrand hnehealth nsw gov au NSW Infant Lung function CEntre Parent Information Statement for Prospective longitudinal observational study on lung function in infants with and without wheezing illness We would like to invite your child to Participate in our study Chief Investigator Associate Professor Joerg Mattes Paediatric Respiratory amp Sleep Medicine Unit John Hunter Children s Hospital Hunter Medical Research Institute Phone 02 492 13000 Email Joerg Mattes newcastle edu au Co Investigators A Prof Bruce Whitehead Prof Paul Foster Dr Jodi Hilton Dr Tanya Gulliver Dr Ana Pereira de Siqueira 196 Why is this research study being done Wheezing is very common in infancy and may develop into asthma We know that wheezing is often related to an abnormal lung function This research will investigate why these abnormalities persist in some infants throughout early childhood and when and why they disappear in others to find better treatments for wheezing and asthma Who can participate Any child younger than 3 years of age with or without recurrent wheezing The child must not have a seizure disorder What does the study invo
239. tcomes that reflect quality control criteria shown in red rectangles with respect to acceptability of the trials or acts Trials 1 3 have met the criteria for acceptability i e r 20 99 duration of pressure plateau tplat 100 ms with SD lt 10 Pa deviation between start and end of the duration of pressure plateau d P1 lt 2 linear regression line 1 50 Of Veocc i e VoI ZA Vol A For trial 4 although the pressure plateau fulfilled the criteria for a relaxed plateau the r was lt 0 99 over 50 expiratory portion This trial was de selected and final results calculated using trials 1 3 only for reporting Note value for V kg and RR should be similar to that obtained previously during tidal breathing and during subsequent tests on the same test occasion a V1 kg lt 5 6 mL kg may be attributable to a mask leak 144 6 3 4 Reasons for invalid trials a In situations whereby assumptions are not valid especially when measuring infants with lung or airway disease e g poor pressure plateau at the airway opening during occlusion due to poor equilibration Modulation of the expiratory flow volume curve by laryngeal braking or alinearity of the flow volume curve due to respiratory disease Following an end inspiratory airway occlusion infants often inspire earlier than usual on the subsequent breath invalidating the calculation of time constant of the respiratory system due to shortened expiratory phase Figure 112 A li
240. that have met quality control criteria but do not have the highest V maxrrc the blank symbols indicate trials that are technically unacceptable and no results are calculated from these see main text for more details 163 Figure 129 shows a PEFV curve that fulfills quality control criteria section 6 5 2 with respect to stability of EEL both pre and post squeeze V kg within the expected range rapid achievement of peak expiratory flow and adequate jacket pressure transmission It is also informative to observe the shape of expiratory limb The example in window B Figure 129 shows the expiratory phase of the forced V V curve to be convex P 5 kPa Pj 3 8 kPa and V maxrc 91 mL s which were similar to results from the previous trial see trend window whereas the following trial from the same infant Figure 130 obtained using P of 6 kPa showed the expiratory curve becoming slightly concave in shape and V maxerc was 87 mL s i e indicating slight negative flow dependence Best Act Act Act3 a Trend window Figure 129 An example of a technically acceptable tidal RTC curve Legend For clarity only one partial forced expiratory flow volume curve is selected with V maxerc being 91 mL s window C Trend window the symbols displayed in grey are tidal squeeze manoeuvres that are valid but currently de selected from calculation display whereas the blank square and circle are data from a manoeu
241. the face mask if it is there would be no need to remove the face mask when the baseline RV data collection has been successfully completed otherwise modifications or a different type of spacer may be required A spacer can be modified to fit the face mask at one end and the inhaler and Neopuff T piece at the other end Figure 93 A spacer with modified fittings for the face mask bronchodilator inhaler and the Neopuff T piece E 5 7 1 1 Baseline measurements prior to bronchodilator challenge e Open the Raised Volume Squeeze program from the LabMan main group interface e Maintain continuous monitoring of the infant s vital signs e Along the menu bar click on Medication e From the drop down menu select Pre to denote Baseline test Figure 94 e Proceed to perform the raised volume squeeze manoeuvres as described in section 5 6 1 2 130 Once 2 3 trials of good quality has been collected click F10 to save and exit program Gently detach the PNT from the face mask Note the infant s vital signs SpO2 heart rate and respiratory frequency Flow feris oK Cancel Figure 94 Select Medication from the menu bar note the drop down menu 5 7 1 2 Preparation and measurements post administration of bronchodilator Re open the Raised Volume Squeeze program and from the menu bar select Medication Figure 94 Enter details of the bronchodilator BD agent e g Albuterol Salbutamol and dosage select
242. the radio button post to denote data being collected following administration of BDI Figure 94 Modify the medical air flow and the Neopuff PIP setting to read 25 cmH 0 Attach the spacer inhaler with the bronchodilator agent in situ to the face mask and deliver 2 puffs of Salbutamol to the infant Remove inhaler device connect the Neopuff T piece and occlude the PIP opening to provide one inflation with 25 cm H20 Record and monitor changes in vital signs every minute for 10 mins 131 Aim for an increase in infant s heart rate by more than 10 In order to achieve this administration of a further 2 inhalations every 2 minutes maximum another 6 puffs may be required Document the time of BD administration s Re adjust the Medical air flow and the Neopuff system to deliver PIP at 30cm H20 i e in readiness to re start RV manoeuvres post BD Continue to record and monitor changes in vital signs every minute and re assess lung function using the RV manoeuvres at 30cm H20 of lung inflations section 5 6 1 2 Once 2 3 trials of good quality have been collected click F10 to save and exit program 5 8 On completion of tests Remove the face mask PNT and jacket Continue monitoring of vital signs until the infant is fully awake If the infant is an in patient he she is escorted back to the ward and handed back to the ward staff If the infant had attended as an out patient he she is offered a drink feed provided this is well tolerate
243. the respiratory system Ts e Body Plethysmography o Functional Residual Capacity FRCpietn o Airway resistance SRer NB needs further validation e Rapid thoraco abdominal compression RTC or Squeeze technique o Maximal flow at FRC V maxerc e Raised volume rapid thoraco abdominal compression RVRTC or raised volume Squeeze technique o Forced Expiratory volume at 0 4 to 1 0 sec FEVo 4 FEVo s5 etc o Forced Expiratory Flows at defined lung volumes FEF s o Forced vital capacity FVC 2 System components a Hardware e All transducers are solid state piezo resistive sensors 224 BabyBody Box e Internal volume 98 L e Box Pressure transducer calibrated in terms of volume change range 80mL at 1000 hPa resolution 0 04 mL accuracy 1 Pneumotachometer PNT Flow sensor Paed PT S Flow range 1500 mL s Flow resolution 1 mL s Flow accuracy 3 Volume resolution 0 1 mL Dead space 1 7 mL Dead space including shutter 4 3 mL Resistance 0 38 kPa L s Sensor for pressure at airway opening e range 5 kPa resolution 0 003 kPa accuracy 2 Shutter for airway occlusion e _ latex inflatable balloon pressure 0 9 bar balloon volume 0 7 ml silent easy to clean dead space added to PNT 2 6 mL accuracy 2 Reservoir for Squeeze RTC e pressure container 55 L e compressed air supply by built in compressorpressure range 1 17 kPa safety valve 20 kPa Rate
244. the tidal RTC technique has several potential limitations including uncertainty regarding extent to which flow limitation can be ascertained in healthy infants In order to overcome these potential limitations the tidal RTC technique has been modified such that lung volume is raised towards total lung capacity TLC prior to applying external compression pressure to force flows enabling the recording of full forced expiratory flow volume FEFV curves similar to those produced by older children and adults in infants e The theoretical background section 2 6 3 and the process of setting or reviewing the sample frequency and contents of result table have been described in sections 3 4 9 1 and 3 4 9 5 respectively e Check that all program settings are correct section 3 4 9 2 e A list of Function keys are available in the Appendix section 8 3 5 6 1 Raised Volume forced expiratory manoeuvres This test requires 2 operators one of whom is responsible for delivering positive inflation pressure to inflate the infant s lungs towards total lung capacity TLC while the other triggers the mechanism to inflate the jacket at the appropriate time to effect a raised volume RTC manoeuvre Technically this is a more demanding method and it is essential to e maintain an airtight seal between the mask and the face during the procedure and e prevent any upper airway compression during application of high inflation pressures 5 6
245. time FET that occurs during early life There is a marked negative age dependency of FEV FVC ratios during infancy and early childhood such that results cannot be interpreted unless appropriate reference equations are used Preliminary collation of RVRTC data from healthy infants 3 149 weeks studied in the United States London and Brazil all of whom were measured using similar custom built equipment and techniques showed an encouraging degree of overlap However more recent data collected with the CareFusion equipment shows the need for equipment specific normative data and or availability of a contemporary control group section 7 5 2 6 3 2 Advantages and Limitations of the RVRTC FEF can only be reliably reported if a valid assessment of FVC is available Underestimation of FVC with concomitant overestimation of FEF will occur if the child breathes in before RV has been reached By contrast underestimation of FVC because of failure to deliver the specified inflation pressure or because of accumulation of gas in the stomach during the lung inflations will result in underestimation of both FEV and FEF Failure to reach flow limitation by using too low a jacket pressure may have minimal effect on FVC but will underestimate both FEV and FEF The raised volume technique is technically more demanding than partial flow volume manoeuvres Extensive training and dedicated personnel who can ensure precision with respect to timing a
246. tive Failure to thrive malabsorption Borderline Borderline Recurrent chest infections Not Done Not Done Recurrent wheezy episodes Prolonged jaundice Biochemical abnormalities Rectal Prolapse Antenatal bowel pathology Family history Screening Recorded Diagnosis Diagnoses including CF and any congenital abnormalities Significant neonatal history if admitted for special care document reason Duration Exclusively breastfed weeks Number of respiratory admissions before diagnosis Number of respiratory admissions between diagnosis and before first RFTs URTI LRI Has a doctor diagnosed upper airway obstruction in your child Not sure Page 3 of 4 202 Subject No Hospital Number Subject ID NHS number Date Family medical History Does anyone in your family have cystic fibrosis None Mother Father Sister Brother Grandfather Niece Half sibling Aunt Nephew Grandmother Uncle Cousin Family history of atopy Have any of the people below been diagnosed with the following by a doctor Mother Father Sister Brother Half sibling Asthma Wheezing Eczema Hay Fever Addit
247. to tidal volume V and respiratory rate the following parameters are often calculated from recordings of tidal breathing tidal expiratory Exp and inspiratory Insp volume and flow inspiratory t and expiratory time t total breath time tzor and tidal breathing ratio tprer te 2 3 Respiratory Mechanics 2 3 1 Introduction Beyond the neonatal period most respiratory disorders are characterised by airway obstruction and narrowing which result in increased work of breathing due to increased airway resistance hence reduced air flow Reductions in airway calibre may occur not only due to obstruction associated with secretions inflammation airway wall thickening or increased bronchial smooth muscle tone but also as a result of reduced lung or chest wall elasticity a lack of alveolar tethering or increased airway wall compliance all of which are associated with increased resistance or reduced flows and volumes during forced expiratory manoeuvres Assessments of respiratory mechanics can provide an indication of lung and chest wall stiffness and of airway calibre or obstruction and hence of the effort that is required to ventilate the lungs work of breathing e Compliance is calculated as the change in lung volume V per unit change in pressure P that is C AV AP and measures the stiffness of the lungs e Resistance which reflects the patency of the airways is calculated as the pressure required to drive flow V
248. tomised database Step 1 e While performing off line data review once the analysis has been finalised the letters OK plus the initials of the person analysing the dataset e g OK AFH should be entered in the cell named Smoker in the Test Information section Figure F lower panel This is needed for each sub set of data denoted by date and time within the Text Directory Figure F upper panel 1 S 0na 112 2 S 0110202 113 Test information 458 04 10 7017 11 37AM Figure F Enabling the export of lung function data from the Babybody Lab4 database Legend The user should enter OK together with initials of the person responsible for the final analysis illustrated in brown rectangle for each sub set of data within the Text Directory 220 Step 2 Check to see whether the Sq_expt and Rc_exprt icons are on your computer m amp Sq_exptirk Rc _exprtirk desktop If not go to C Lab4 and scroll down the list of files Identify select and highlight the application file Sq_expt exe create a shortcut of this file onto your Desktop Repeat the same procedure and create a shortcut for the application file Rc_exprt exe on your Desktop Step 3 Rc_exprt Ink this icon file enables the user to download numerical values from the test data collected using the following two programs a Tidal breathing a b Resistance Compliance Double click on the Rc_exprt Lnk icon will open up a new wi
249. tructive pulmonary disease Semin Fetal Neonatal Med 2012 17 2 112 118 Pike K Pillow JJ Lucas JS Long term respiratory consequences of intrauterine growth restriction Semin Fetal Neonatal Med 2012 17 2 92 98 Lum S Bush A Stocks J Clinical pulmonary function testing for children with bronchopulmonary dysplasia Pediatr Allergy Immunol Pulmonol 2011 24 2 77 88 7 2 Sedation and sleep state NICE Guideline Development Group Sedation in children and young people sedation for diagnostic and therapeutic procedures in children and young people http www nice org uk nicemedia live 13296 52130 52130 pdf Issued December 2010 NICE clinical guideline 112 accessed 08 02 2014 Gaultier C Fletcher ME Beardsmore C et al Respiratory function measurements in infants measurement conditions Working Group of the European Respiratory Society and the American Thoracic Society Eur Respir J 1995 8 6 1057 1066 Jackson EA Rabbette PS Dezateux C et al The effect of triclofos sodium sedation on respiratory rate oxygen saturation and heart rate in infants and young children Pediatr Pulmonol 1991 10 1 40 45 Rabbette PS Dezateux C Fletcher ME et al Influence of sedation on the Hering Breuer inflation reflex in healthy infants Pediatr Pulmonol 1991 11 3 217 222 Tepper RS Morgan WJ Cota K et al Physiological growth and development of the lung during the first year of life Am Rev Respir Dis 1986 134 3 513 519 Pr
250. ts as cystic fibrosis clinical trial endpoints Am J Respir Crit Care Med 2010 182 1387 1397 Colin AA McEvoy C Castile RG Respiratory morbidity and lung function in preterm infants of 32 to 36 weeks gestational age Pediatrics 2010 126 115 128 Ranganathan S Linnane B Nolan G et al Early detection of lung disease in children with cystic fibrosis using lung function Paediatr Respir Rev 2008 9 160 167 McEvoy C Schilling D Spitale P et a Decreased respiratory compliance in infants less than or equal to 32 weeks gestation delivered more than 7 days after antenatal steroid therapy Pediatrics 2008 121 e1032 e1038 Linnane BM Hall GL Nolan G et al Lung function in infants with cystic fibrosis diagnosed by newborn screening Am J Respir Crit Care Med 2008 178 1238 1244 Broughton S Sylvester KP Fox G et al Lung function in prematurely born infants after viral lower respiratory tract infections Pediatr Infect Dis J 2007 26 1019 1024 Yemen S Gaston B Lung function test results in normal infants a COPSAC sequel J Allergy Clin Immunol 2009 123 658 659 Bisgaard H Loland L Holst KK et a Prenatal determinants of neonatal lung function in high risk newborns J Allergy Clin Immunol 2009 123 651 657 657 189 e Friedrich L Pitrez PM Stein RT et a Growth rate of lung function in healthy preterm infants Am J Respir Crit Care Med 2007 176 1269 1273 7 8 Assessment of bronchodilator responsivene
251. tter balloon During the first year of life healthy infants may achieve pressure equilibration after an airway occlusion within 0 5 1 0 s whereas older infants and those with airway disease may require longer However if the duration of airway occlusion is too long the infant may make an inspiratory effort before jacket inflation occurs Jacket compression time the program allows the jacket inflation to be set between 0 4 and 3 seconds 70 V 1 June 2014 e Max change in Po for the P plateau during an airway occlusion to be accepted as a stable plateau the maximal change in value between the start and end of the plateau should not exceed 15 e Max P standard deviation the lowest SD is set for the Pao plateau obtained during an airway occlusion to ensure identification of a stable Pao plateau Settings pressure transmission x Occlusion time before jacket compression ps s Jacket compression time 0 s Cancel Max change in Pao m50 Max Pao standard deviation 0 05 G kPa Default Figure 37 The recommended default settings for the assessment of jacket pressure transmission 3 4 8 8 Contents of tidal RTC result table To review and or edit the list of variables displayed in the results table Go to the menu bar click on Program gt Modify settings Return to the menu bar click on Settings gt modify gt Parameter list gt Contents of Table Browse through the li
252. uring and analysing FRCpieth data in infants are presented in sections 5 4 4 and 6 4 2 5 Plethysmographic assessments of airways resistance Although plethysmographic assessments of airways resistance have proven to be a valuable outcome measure in infants in the past this was at a time when infant plethysmography traditionally used a heated rebreathing system to provide respired gas under BTPS conditions to avoid thermal artefacts when assessing Raw Concerns about potential infection risks accumulation of CO during rebreathing and the need to make the technique more widely available prompted a search for alternative solutions Regrettably initial attempts to apply electronic thermal compensation when calculating Ray in infants as in the current CareFusion BabyBody system have proved disappointing with physiologically implausible results in both healthy infants and those with lung disease section 7 4 3 This suggests that algorithms that are more sophisticated may be required to cope with the added complexities of undertaking these measurements in such small nose breathing subjects Consequently although the technique for collecting data for Ray has been included in this manual section 5 4 3 its use is not recommended until further refinements to software have been implemented and fully validated 2 6 Rapid Thoraco abdominal Compression RTC or forced expiratory manoeuvres Spirometry whereby the subject inspires to TLC and
253. ut less than 5 repeat calibration with regular complete pump strokes and avoid heating the syringe but e If Corris greater than 5 in presence of apparently complete strokes check for leaks and dirt stains ensure correct assembly of PNT components and pump volume setting i e 100 mL section 3 4 11 1 then repeat calibration e If Qis greater than 1 repeat calibration with regular pump strokes 86 V 1 June 2014 e Once the calibration has been completed satisfactorily click on F10 gt save new data and exit program Once the volume calibration for the PNT has been successfully completed the Masterscreen system is ready for lung function assessments namely tidal breathing parameters passive mechanics and if desired the tidal volume and raised volume forced expiratory manoeuvres These measurements are performed with the Box opened The following sections describe the preparation of the plethysmograph if assessment of the resting lung volume FRC is also required 3 4 11 5 Preparation for the calibration of the plethysmograph e The body plethysmograph or box which has an internal volume of 98 litres when empty is calibrated using an internal calibrated pump which delivers known cyclical volume changes 8 mL to calibrate plethysmographic pressure in terms of volume and step changes to assess the mechanical half life time constant t of the box i e the duration it takes for an induced
254. vailable Interpretation of results should take into account previous risk factors including preterm delivery intrauterine growth retardation and treatment during the neonatal period 2 7 1 What is Normal Reliable interpretation of pulmonary function results relies on the availability of appropriate reference data to help distinguish between health and disease The use of inappropriate reference equations can lead to serious errors in diagnosis Although clinicians in respiratory medicine have become familiar with the concept of expressing lung function as percent predicted observed predicted 100 where the predicted value is derived from reference equations this does not take into account the variability between healthy subjects which varies according to age and the outcome under investigation section 7 5 Expression of lung function results as Z scores or Standard Deviation SD score is therefore preferable The Z score is a mathematical combination of the percent predicted and the between subject variability to give a single number that accounts for age and height related lung function variability expected within comparable healthy individuals The upper and lower limits of normal ULN and LLN are conventionally defined as Z score of 1 64 a range that encompasses 90 of healthy subjects However due to increased uncertainty regarding reliability of reference ranges for infants and the fact that multiple LFTs are often used in the asse
255. visibly clean hands 5 8 2 2 Cleaning and disinfecting at end of test session 5 8 2 2 1 Apparatus accessories and surfaces e A hard surface cleaner wipes disinfectant recommended by the Infection Control Team of the local institution is used to clean the interior and exterior of the plethysmograph including the baby tray and its resting surface stadiometer and weighing scales Neopuff resuscitator Pule oximeter and the oxygen saturation probe Computer keyboard and resting top all working surfaces are also cleaned wiped e discard the used putty and the single use T piece tubing and connector e high temperature method is used to disinfect the face mask e the squeeze jacket and bladder NB place a stopper to close off the connector opening first are washed in hot soapy water rinsed well and hung up to dry NOTE the bladder supplied by CareFusion may need to be discarded after use or retained strictly for single patient use only e the measuring tape for assessing head circumference is also washed in hot soapy water rinsed well and hung up to dry e used linen is bagged and sent to designated laundry e ahard surface cleaner wipes disinfectant is use to clean the infant cot and mattress 5 8 2 2 2 PNT and balloon shutter e Remove the PNT from the sensor housing and disassemble into its component parts and disconnect the balloon shutter from its tubing e Wash the balloon shutter note remember to cover
256. vre that is invalid or technically unacceptable the circles represent Pj and the squares the corresponding V naxrrc The blue square and circle represent the currently displayed flow volume curve in window B also in blue and it was the 6 of a total of 7 manoeuvres for this test showed by red oval in the trend window As seen from window C EEL s of lt 5 suggests that baseline EEL was stable prior to onset of jacket inflation and after the squeeze manoeuvre The EEL window A returned to baseline relatively quickly indicating an leak free mask seal V kg was within the expected range of 7 14 mL kg window C an additional clue that there was no mask leak during data collection The peak forced expiratory flow PEF was achieved before 30 of V had been exhaled window B result for jacket transmission window C is displayed in both absolute value P j 2 34 kPa and relative efficiency Pjtr 61 7 164 Best Acti Act2 Act J Volume ml 504 Vmax FRC ml s 4 Trial 7 of 7 gt Volume ml o e o eere e ep 0 1 2 3 4 5 6 td 8 Trial number Figure 130 Tidal RTC curve evidence of flow limitation Legend This example trial 7 of 7 is derived from the same set of data as illustrated in Figure 129 In comparison with the previous example trial 6 of 7 Figure 129 an increase of 1 kPa of reservoir pressure 0 7kPa P did not elicit further increase in V maxerc and th
257. ws Do not use substances that contain ammonia or alcohol DO NOT USE any of the following methods or solutions on the Vmax components Temperatures above 130 degrees F The Sterris system Peroxyacetic Acid 35 ANY Bleach solutions ANY Pre Enzymatic cleaners Alcohol Glutaraldehyde solutions above 2 6 194 8 3 Masterscreen system Function icons keys Test modules Tidal breathing module Crs Rrs module Plethysmographic module Tidal Squeeze module RV Squeeze module F1 Start of tidal breathing Start display of tidal breathing Start of watch Standby Standby registration F2 Calculate and display of trial Start measurement Start resistance Start measurement Start baseline measurement results measurements F3 amp Reanalyse old measurement Start of FRC measurement Trigger maneuver Trigger maneuver F4 amp Reanalyse old show trial results Show trial results measurements F5 Read amp ASCII files measure pressure transmission Pressure transmission results F6 Undo manual changes Calculate display trial setting for pressure Change reservoir pressure result F7 Display of final results Calculate parameter and show result Calculate display result show Results Reanalyse F8 Flow vol zero adjustment Flow vol zero adjustment Flow vol zero adjustment Flow vol zero adjustment Flow vol zero adjustment F9 New start of complete
258. x section 8 2 134 6 Data interpretation and management 6 1 Preparation for data analyses Although results of online lung function analysis are displayed throughout data collection period it is advisable to inspect the data carefully after completion of the test session since off line data review enables analysis to be modified or refined in accordance to quality control criteria thus improving quality of results In general the definitive or final results should be printed and stored with the infant s documents In order to prepare for a clinical report both lung function results and anthropometric measurements are expressed as Z or SD scores using appropriate reference equations section 6 7 and see section 8 9 for an example of infant lung function report When reviewing lung function data it is crucial to ascertain whether data have been acquired a during periods of quiet sleep when respiratory pattern was stable and b without the presence of a mask or PNT leak Figure 96 E Tidal v4 60 4 0 18 01 2012 14 14PM Act2 Act3 Act4 ActS 22 23 Figure 96 Off line data review and or analysis of tidal breathing data Legend The upper left window shows regular breathing pattern and stable EEL before and after the test occlusions indicating data were collected while the infant was in relaxed quiet sleep and that no mask PNT leak was detected e to review or analyse stored data go to LabMan Main groups screen F
259. xerc results from an acceptable test cccccssssceceeesessessaeeeeees 123 An example of assessment of jacket pressure transmission during RTC 124 Schematic diagram showing the apparatus set up for performing the Raised Volume MANOCUVIES sinners eres miti NEEE NENES NESE cteavtees 126 RVRTC apparatus se up for RVRTC manoeuvres ccccccccecesssssssececeescsssesseaeeeeess 127 Time based trace showing 5 passively inflated breaths and timing of jacket compression during a raised volume RTC manoeuvre ssssssssssesssssssessrrsessese 128 Screen display at completion of a raised volume manoeuvre sssssssssesesse 129 A spacer with modified fittings for the face mask bronchodilator inhaler and the Neo puth T pisce nare e ae a a n E E E ves een whens Soa a e Sa 130 Select Medication from the menu bar note the drop down menu 131 The balloon shutter with its metal tip covered before soaking in liquid 134 Off line data review and or analysis of tidal breathing data c ccccsceeeees 135 Tidal Breathing menu enabling retrieval of stored data for review and or PEA AAEE A ETRA E EEEE eotacd ik AN teens eects 137 Test directory showing stored data according to test data time and type of measurements as indicated by the red rectangular DOX ccsssscccceeeseessreees 137 The red circle indicates the 2 trials or Acts of tidal breathing data saved to the Gata base viv sceccessiesdvetescacdessac
260. y press PrtScn to print a copy of the results Figure 63 and file with the infant s test document NOTE once the F10 icon has been activated and data saved the screen display will no longer be available for printing e Click F10 to Save and exit program e If the box calibration is unsatisfactory click F9 to either save or cancel results before repeating the calibration process 3 4 11 5 3 Shutter balloon test e This procedure is performed to check the efficiency and integrity of the latex balloon e The Shutter balloon test is available in the following programs Baby Res Compliance 91 V 1 June 2014 Baby Bodyplethysmography Squeeze Raised Volume Squeeze e Open any one of these programs From the menu bar select and activate shutter balloon test For the purpose of demonstration Figure 64 has been derived from the Baby Bodyplethysmography program NOTE This procedure MUST NOT be performed while face mask with PNT and shutter are applied over the infant s face Instead the shutter should be detached from the PNT and held away from the face while the shutter balloon test is carried out Figure 64 Option for Shutter balloon test is highlighted by red circle Shutter balloon test Shutter balloon test Start shutter balloon test with lt Start gt Ce r Shutter balloon test ended successfully mE Note Note Attention The shutter balloon must not be teste
261. y after arriving to the LF Lab the infant is weighed naked at least twice using a pair of electronic digital scales Seca e When two consistent readings have been obtained the value is reported in kilograms to 3 decimal places as the test weight Gaultier et a 1996 section 7 2 This is used to calculate the dosage of chloral sedation as well as the correction factor for plethysmographic studies Note The scales should be checked at least yearly for accuracy and re calibrated if necessary by appropriate personnel e g a biomedical engineer or the manufacturer 4 3 2 3 2 Crown heel length e Using a calibrated infant stadiometer Harpenden measuring table see Appendix section 8 1 the infant s crown heel length is measured by 2 persons usually at the completion of lung function tests while the infant remains slightly drowsy e The infant is positioned along the mid line of the stadiometer One person gently but firmly holds the infant such that the crown of his her head is touching the mid line of top plate of the stadiometer whilst the second person gently depresses the infant s knees to fully extend the legs 97 V 1 June 2014 The sliding footplate is adjusted to rest firmly against the upright soles of the feet The crown length length is read off a counter once the footplate has been locked into position This procedure is repeated at least twice with the crown heel length being reported to 1 decimal place as the m
262. y becomes stable i e no further upward drift indicating thermal equilibrium has been reached within the box Figure 80 115 V 1 June 2014 Best Acti Act2 Act3 Act4 FRCp 2922 291 5 293 0 Flow ml s 0 3 5 3 10 3 10 1 106 28 3 63 1 23 4 0 38 9 10 Pao kPa Resistance 5 0 SReff kPa s Resistance Trend 45 40 325 3 0 25 20 1 5 1 0 Modification of resistance measurement possible Figure 80 Recording of plethysmographic airway resistance Legend The box volume signal shown in turquoise which initially drifts upwards progressively becomes stable 16 seconds after commencement of data recording indicating thermal equilibration has been achieved The upper right window displays results for the effective airway resistance Res which is one of many ways of calculating Raw Kirkby et al 2010 ERJ section 7 4 3 5 4 4 To start FRCpien data recording e As soon as the box volume signal has become stable Figure 80 double check that the infant remains in quiet sleep e Click on F3 Start FRC measurement to activate inflation of the shutter balloon and hence start of airway occlusion to measure FRC Figure 81 Note Although infrequently at this part of the test when the infant wakes suddenly immediate attention action is required to prevent distress the box needs to be opened quickly and the 2 part support arm loosened while being safely supported by the user and the PNT mask be
263. y you with the research records If there are any unforeseen ethical problems with this study you must inform a representative of the sponsor and follow this up in writing Rec No 09H071314 Version 1 dated 09 02 09 page 2 of 2 199 8 6 Questionnaire background information Subject No Hospital Number Subject ID NHS number Date Baby s Surname First name Sex Male Female Child s address Mother s first name Mother s DOB Father s first name Father s DOB Questionnaire for GOSH CF referral Background Information Date of birth Birth weight kg Estimated date of delivery Gestational age weeks days Date of test 1 Date of test 2 Date of test 3 Mother s last name Mother s email Father s last name Father s email Telephone no Home Mum s work Mum s mobile Dad s work Dad s mobile other Social history Does the child s natural mother have parental responsibility Yes No Not sure Mother s most recent job Title description state if self employed coding Father s most recent job Title description state if self employed coding Page 1 of 4 200 Subject No Hospital Number Subject ID NHS number Date Years mother spent in full time education after the age o

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