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part 1 of the European spirometry training programme
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1. Select the manoever with the highest sum of FVC REVERSIBILITY TESTING BRONCHODILATOR TEST The response of the airways to administration of bronchodilating agent can be assessed in two ways After a single dose of brinchodilator After clinical trial lasting 2 8 weeks Next slides describe the test with a single dose of bronchodilator ERS PERFORMING BRONCHODILATOR TEST Baseline spirometry before the drugs affecting lung function have to be withdrawed with proper timing Administration of standard dose of LABA Postbronchodilator spirometry at least 15 minutes after delivering bronchodilator Assessment of the results 70 IMPORTANT Both spirometries have to be properly performed acceptability and repatabilty criteria should be met The drug should be properly delivered knowledge of inhalation therapy needed ERS ASSESSMENT OF BRONCHODILATOR TEST Bronchodilator response is assessed as an absolute change of FEV1 and FVC from the baseline post pre in ml and as a percent change in relation to prebronchodilator value expressed in predicted post pre pre increase of gt 12 of FEV1 or FVC in comparison to baseline and change gt 200 ml is considered significant Note there exist also a criterion relating the change expressed in predicted in that case an increase gt 12 of predicted and a change gt 200 ml is considered as significant response AN EXAMPLE Bez
2. For more information on the European Spirometry Training Programme programme please visit http hermes ersnet org spirometry HERMES LINKS ADULT D 1 Pulmonary function testing Target audience Respiratory therapists nurses respiratory physicians general practitioners trainees medical assistants Chairs I Steenbruggen Zwolle The Netherlands B G Cooper Birmingham United Kingdom POSTGRADUATE COURSE PAGE 14 00 Introduction F Burgos Barcelona Spain 14 10 Anatomy physiology and pathophysiology required for spirometry short 5 summary J D Leuppi Basel Switzerland 14 30 Definitions of spirometric values short summary 17 J D Leuppi Basel Switzerland 15 10 Spirometry equipment 27 J Lloyd Staffordshire United Kingdom 15 45 Break 16 05 Indications and contraindications of spirometry testing 37 J D Leuppi Basel Switzerland 16 15 Quality assurance theory 43 F Burgos Barcelona Spain 16 30 Evaluation of spirometric results 59 W Tomalak Rabka Poland 17 15 Overview of part II completion and submission of the ERS spirometry 81 workbook F Burgos Barcelona Spain WORKSHOP PROGRAMME EDUCATIONAL SKILLS WORKSHOP Workstation 1 Spirometers demonstration of how different types of spirometers work and how to clean and maintain them J Makonga Braaksma Woudenberg Netherlands B G Cooper Birmingham United Kingdom Workstation 2 Infection control perform cleaning procedur
3. Peak flow meters can be obtained from NHS Logistics These are not labelled for single patient use April 2005 This report was commissioned by the British Thoracic Society and carried out on their behalf by the National Respiratory Training Centre Warwick 102 WORKSHOP STATION 3 Spirometry performing the test safety measures selecting the best values simulating errors Dr Jana Kivastik Prof Dr Jorg Daniel Leuppi University of Tartu Department of Internal Medicine Department of Physiology University Hospital Basel Ravila 19 Petersgraben 4 50411 Tartu 4031 Basel ESTONIA SWITZERLAND jana kivastik ut ee Jleuppi uhbs ch Aims This workstation is planned to give the participants the possibility to perform spirometric tests to learn how to select the best values from those measurements and also discuss and simulate errors that can occur during the testing Small group hands on learning in this workshop is tightly connected with theoretical parts of ESDL Part I all modules covered can be found in the description of the training programme 1 We will deal mostly with module 5 spirometry technique but also with parts of modules 2 definitions of spirometric values and 7 evaluation of spirometric results Summary Spirometry is recommended for the diagnosis and management of asthma and chronic obstructive pulmonary disease However for results of the spirometric measurement to be valid the test must be performed in a
4. Temperature should be measured and not assumed to be constant even over the course of one testing session References Standardisation of Spirometry M R Miller et al E R J 2005 26 319 338 ATS ERS Task Force Standardisation of Lung Function Testing Lung Volumes and forced ventilatory flows Official statement of ERS E R J 1993 6 Suppl 16 5 40 26 Spirometry equipment Mrs Julie K Lloyd 118 Upper Way Upper Longdon Rugely WS15 1QD Staffordshire United Kingdom julie lloyd heartofengland nhs uk 27 ESDL PART 1 MODULE 3 SPIROMETRY EQUIPMENT ERS Spirometry equipment Spirometers Computer and software e Mouthpiece Tubings nose clips and bacterial filters Spirometer calibration syringes 3 litre Thermometer hygrometer and barometer Stadiometer and balance Reference values Standards amp instructions for spirometry ERS Spirometry measurement principles Volume measuring devices As the subject As the subject in exhales the bellows and exhales the expands the chart piston moves and moves and the the movement is stylus records recorded electro nicaly ERS ERS Spirometry measurement principles Flow measuring devices As the subject in and exhales a pressure fall Px Py is generated across the screen The pressure fall is y proportional to flow which can be integrated to a volume V Other measurement principles Ul
5. for gt 1s and the subject has tried to exhale for gt 3s in children aged lt 10 years and for gt 6 s in subjects aged gt 10 years END OF TEST CRITERIA No change in volume for gt 1s ae Exhalation time gt 6s 65 ACCEPTABLE MANOEUVER ERS The patient cooperates well A steep rise of the first part of the FVC curve A pointed peak the PEF in the first part of expiration A smooth Flow Volume curve Expiration lasts for at least 6s and exhibits a plateau Inspiration and expiration give the same vc FREQUENT PROBLEMS DURING PERFORMING ERS FVC MANOEUVER FREQUENT PROBLEMS DURING PERFORMING GN FA ex SZ 14 FVC MANOEUVER F Vol L 66 ERS FREQUENT PROBLEMS DURING PERFORMING FVC MANOEUVER Ma vA Another example gt ERS FREQUENT PROBLEMS DURING PERFORMING FVC MANOEUVER Submaximal effort note position of PEF ERS FREQUENT PROBLEMS DURING PERFORMING FVC MANOEUVER Glottis closure abrupt end Expiratory time 1s 67 ACCEPTABLE MANOEUVER The patient cooperates well A steep rise of the first part of the FVC curve A pointed peak the PEF in the first part of expiration A smooth Flow Volume curve Expiration lasts for at least 6s and exhibits a plateau Inspiration and expiration give the same vc REPEATABILITY Repeatability is the closeness of agreement be
6. panic values v Hardware and software upgrades version and data of change v Preventive maintenance service v Records of continuing education v Internal audit References 1 Application of a Quality Management System Model for respiratory services approved guideline 2 edition clinical and laboratory standards Institute NCCLS HS4 A2 Vol 26 No 15 Vol 2 No23 2 Jack Wanger Pulmonary Function Testing A practical aaproach Third Edition Jones amp Bartlett Learning 2012 3 M R Miller J Hankinson V Brusasco F Burgos R Casaburi A Coates R Crapo P Enright C P M van der Grinten P Gustafsson R Jensen D C Johnson N Macintyre R MacKay D Navajas O F Pedersen R Pellegrino G Viegi and J Wanger Standardisation of spirometry Eur Respir J 2005 26 319 338 Evaluation 1 Calibration is a After introducing environmental conditions then calibrating the spirometer with a 3 L syringe the device corrects the deviation automatically b Checking if temperature and pressure are measured c Check if the spirometer is linear in all flows d Verify if barometer is in a clean room 2 Validation Checking is a Verify spirometer linearity deviation and correcting the errors manually b Recommended to do in all spirometer c Checking the humidity of spirometer d bandc 3 Some devices cannot be calibrated a Just once a week b False all devices need to be calibrated c True some devices are calibrated and don
7. score of 1 64 Using of a fixed percentile value 80 or 70 may lead to erroneous results because LLN changes with age Thus in older people overestimation of obstructive ventilator defect is observed The interpretation of spirometric results should answer the question whether there is a ventilator defect and if so what is the degree of the disturbance With spirometry obstructive defect can be stated when the FEV1 F VC factor is below the lower limit of normal The severity of obstruction is quantified using the value of FEV1 expressed as a percentage of predicted When FEV1 F VC remains within normal limits and FVC is below LLN a restrictive ventilator defect may be suspected but confirmation of this requires the measurement of total lung capacity TLC done either by plethysmography or gas dilution method 3 References 1 MR Miller R Crapo J Hankinson et al General considerations for lung function testing Eur Respir J 2005 26 153 161 2 MR Miller J Hankinson V Brusasco et al Standardisation of spirometry Eur Respir J 2005 26 319 338 3 R Pellegrino G Viegi V Brusasco et al Interpretative strategies for lung function tests Eur Respir J 2005 26 948 968 Evaluation MCQs for the presentation 1 Properly performed spirometry should include a At least one acceptable manoeuver b At least three acceptable manoeuvers c At least five acceptable manoeuvers d Atleast eight acceptable manoeuvers 60 2 T
8. t need it d Some devices only need to be calibrated once a year 49 Quality control is Calibrating with a 3L syringe at all flows in the spirometer Review spirometer Assess spirometer verify all flows and periodically perform biological controls Perform biological controls Please find all answers at the back of your handout materials 50 ESDL PART 1 MODULE 6 QUALITY ASSURANCE ERS Definition Quality Assurance The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled CALIBRATION AND VERIFICATION 51 ERS Spriometer calibration Why do we do it Calibration versus verification How do we do it Why e To ensure accuracy of equipment To ensure good quality measurement over time To check for equipment error failure ERS Calibration V Verification e Calibration equipment is internally adjusted to read volume absolutely correctly each day session Verification equipment is checked to see whether it reads a calibration signal within acceptable limits 52 ERS Calibration For flow measuring devices the calibration volume must be injected at different rates between 2 and12 L s Volume accuracy should be within 3 at all flows Calibration syringes must be kept at the same temperature and humidity as the spirometer Syringes must be calibrated annually
9. Biological Control Bjp gt QC Testin A biological normal quality control BioQC refers to a healthy non smoking individual with normal and stable lung function who is tested on a regular basis as a control Frequently office and staff personnel are asked to perform this function The facility should identify two BioQC subjects It is recommended that al least two healthy non smoking individuals should be identified to perform spirometry testing to assess the overall operational status of the spirometry system Results are monitored to assess changes in equipment performance that may be undetected in routine calibration Establishing the BioQC Normal Range 1 Perform 10 replicates on each BioQC subject over a period of several days Ideally this should entail a single test performed each day however a maximum of 2 tests spread out within any single day e g morning and afternoon may be used 2 Use the Normal Range Calculator to determine the acceptable ranges for each person This worksheet takes the average of the replicates and calculates two standard deviations SD which constitutes the normal range for this subject e Fill in the values generated by the BioQC subjects The average standard deviation SD and coefficient of variation CV will automatically be calculated e There should be a maximum of 10 between the highest and lowest FVC and FEV1 values e The calculated coefficient of variation CV should be 3 or less
10. examining the data from all the suitable curves d Eleven manoeuvres are considered a practical upper limit for most subjects 2 The flow volume graph allows assessment of all of the following EXCEPT a The variability in effort b The magnitude of effort c The effect of coughing bouts during manoeuvre d Mouthpiece leaks 3 Which of the statements about preparation of subject is INCORRECT a Itis preferable to avoid smoking within at least one hour of testing b It is preferable to avoid performing vigorous exercise within 4 hours of testing 105 It is preferable to avoid wearing clothing that substantially restricts full chest and abdominal expansion The decision to avoid bronchodilators depends on the reasons why the spirometry was ordered Which of the statements about the correct position to perform spirometry is INCORRECT a b c e Testing should be done in the standing position Correct posture is with chin slightly elevated and neck extended Mouth should be put firmly around the mouthpiece the tongue should be out of the mouthpiece Dentures should be left in place if they are not loose A nose clip should be used or the subject can pinch his her nostrils with fingers Which of the statements about height and weight measurement is INCORRECT a b c d Height and weight are recorded with a patient wearing indoor clothes and being without shoes There is no need to measure height of an adult pa
11. 2003 o Soaked for I hour in hypochlorite solution 1000 parts per million if there is potential for but no visible blood the strength should be 10 000 parts per million and o Dried thoroughly prior to further use e Dry powder devices and device parts that cannot be washed should be decontaminated by thoroughly wiping with an appropriate alcohol wipe 7 Spacer devices should be single patient use whenever practicably possible If multiple patient use is unavoidable they must be decontaminated each time they are used as in section 7 8 If the same peak flow meter is used for different patients e A peak flow meter should be purchased that can be used between patients e Disposable mouthpieces with one way expiratory valves should always be used and an appropriate financial budget allocated for this purpose e These peak flow meters should be washed and dried according to the manufacturer s instructions 9 Inspiratory flow meters should be used and cleaned according to manufacturers recommendations Disposable mouthpieces with one way inspiratory valves should always be used and an appropriate financial budget allocated for this purpose References National Institute for Clinical Excellence NICE 2003 Infection Control Prevention of healthcare associated infection in primary and community care Clinical Guideline 2 NICE London If an ultrasound bath is not available manual washing procedures should be adhered to NICE 2003
12. Chronic Obstructive Pulmonary Disease COPD is characterised by airflow obstruction The airflow obstruction is usually progressive and is not fully reversible Predominantly caused by smoking ERS Obstruction Reduction of maximal airflow from the lung in relation to the maximal volume It implies airway narrowing during exhalation and is defined by a reduced FEV1 F VC ratio Appears in asthma and COPD ERS Restriction Maximum achievable lung volume has diminished This implies a reduction in TLC Due to e g surgical removal of part of the lung lung fibrosis e Normal FEV1 F VC ratio 15 ERS Want to know more e About respiratory mechanics Respiratory_mechanics_Caen ppt About PEF and respiratory mechanics Peak expiratory flow ESDL ppt About Forced expiratory flow and respiratory mechanics Forced expiration ESDL ppt 16 Definitions of spirometric values short summary Prof Dr Jorg Daniel Leuppi Department of Internal Medicine University Hospital Basel Petersgraben 4 403 1Basel Switzerland jleuppi uhbs ch Summary This module examines the definitions and calculations of spirometric indices Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time The primary signal measured in spirometry may be volume or flow The test effort can be presented as a flow volume loop or as a volume ti
13. Criteria Reference values source Action to be taken in case of panic values Hardware and software upgrades Preventive maintenance service Records of continuing education ERS Patient errors Sub maximal effort usually due to Poor understanding Lack of motivation Lack of co ordination Incomplete inspiration Inadequate rest between attempts ERS Patient errors Leaks usually due to Puffing cheeks out Lips not tightly round the mouthpiece Loose fitting dentures Teeth not over the mouthpiece Tongue obstructing the mouthpiece Facial palsy ERS Technical errors Poor start Early termination Cough easy to detect just need to listen Sub maximal effort Unable to obtain 3 technically acceptable efforts Poor start Flow www spirxpert com Early termination Flow PEF www spirxpert com www spirxpert com 56 Sub maximal effort Flow www spirxpert com ERS Over reading Quality of spirometry increases with expert over reading and constructive feedback Independent quality review Useful in primary and secondary care Example of feedback Flow PEF Exhalation too short Underestimation of FVC Overestimation of FEV1 FVC 57 Example of feedback Probably no maximal inspiration FVC s differ gt 0 15L FEV1 s differ gt 0 15 L More manoeuvres needed with proper coaching No interpretation p
14. age height gender seston ye 73 yma Fomio age 26 yosrs Heighe m Height im Mics height 1 80 my Females height 170mm ape cepam Ago toaz Graphical presentation of the equations for adults in the previous table 35 ERS The variability of normal lung volumes Factors accouting for RSD Body weight Obesity may decrease FRC and TLC Posture FRC decreases in the supine position This is enhanced in anaesthesia Physical exercise some evidence that FRC VC and TLC increase in children receiving intense swimming training Genetic factors Twin studies indicate smaller intra pair variation in lung volumes of identical twins than of non identical twins Ethnic differences Environment Natives of high altitude reportedly have more alveoli and larger lung volumes than lowlanders Air pollution and maternal smoking influence lung growth RS omments The figures clearly show that for a given age FVC and FEV1 increase with height but the ratio between them is unchanged This only reflects that large people have larger spirometric values than small people For a given height however both FVC and FEV1 decrease with age and FVC decreases slightly more than FEV1 This causes the ratio between them to decrease The most likely cause is the decrease in number of elastic fibres in the lung with ageing The ECCS equations are known to give lower predictions than many other prediction equations and will therefor
15. and explain what you did would do to overcome the problems The problems may include patient technical or equipment issues 92 ESDL Workstation 1 Spirometers demonstration of how different types of spirometers work and how they are cleaned and maintained Three types of Spirometers 1 Rotating vane 2 Pneumotachograph 3 Ultrasonic 1 Rotating vane or turbine actually a rotating vane which spins because of the air flow generated by the subject The revolutions of the vane are counted as they break a light beam eg Carefusion Micromedical Cosmed Mir We discern models with disposable vanes MIR and models with non disposable vanes which ideally should be used with a bacteria filter or should be desinfected after each patient Cosmed Carefusion etc Strengths Stable and accurate Weaknesses Difficulty in detecting low flows difficult to clean except the disposable most models can t measure inspiration wo 2 Pneumotachograph Flow V is derived from the pressure difference over a small fixed resistance offered by a fine metal mesh We discern fixed devices eg Vitalograph which have to be used with a bacteriafilter and disposable devices USB type eg Welch Allyn Strengths Measures inspiration as well very cheap and hygienic are the models with disposable flow transducers Weaknesses Often problems reaching a plateau drift Not very stable too much shaking of the system w
16. standardized manner The American Thoracic Society ATS and the European Respiratory Society ERS have published guidelines to assist those performing spirometry tests 2 4 For those working in primary care settings there is also a more recent paper with the proposed standards for diagnostic spirometry in primary care 5 Those recommendations include detailed descriptions of equipment performance validation and quality control subject performance and measurement procedure Only a short summary is presented below In addition you can watch online the official ERS video about conducting the spirometry 6 Before the measurement starts Preparation of pulmonary function equipment prior to test performance is essential to obtain reliable data Different types of spirometers and their quality and infection control will be discussed in other workstations In addition to preparing the equipment there are also several aspects in preparing the subject for calculating the reference values there is a need to record patient s age and measure the height and weight and also record the type dosage and time of relevant medication The subject must loosen any element being able to block his her breathing like a collar or a belt The test can be carried out in a sitting or standing position and the position should be recorded on the report Spirometry depends upon the effort and cooperation of the subject performing the test The person administrating th
17. the course participants will a understand the importance of best practice in spirometry service management b correctly perform high quality spirometry and reversibility testing and fully competent to practice spirometric tests Part Il Spirometry Competency Based Training and Assessment Module 3 Spirometry Equipment Review of workbook assignments small group hands on learning 85 ERS SPIROMETRY WORKBOOK Your workbook must consist of the following sections SECTION A 1 The contents page 2 Your Curriculum Vitae 3 Your Spirometry Training Course attendance certificate and or accreditation of prior learning 4 Background information about your work environment which should include a Local arrangements for spirometry testing b Method of referral e g GP nurse led clinics etc c Number of tests performed weekly monthly etc and the type of patients you are testing e g screening for occupational health asthma COPD etc d Where the tests are performed and the staff performing the tests e g doctor nurse clinical physiologist or other ERS SECTIONA 2 CURRICULUM VITAE Felip Burgos s a respiratory scientist in the Diagnostic Respiratory Center Lung Functon Laboratory of Respiratory Department in Hospital Clinic University of Barcelona Spain During the last 35 years he has been involved in Lung Function Laboratory in several topics specially related to values and standardi
18. 2 agonists Workstation 4 Calibration and quality control how to calibrate different devices and perform biological control procedures Mr Felip Burgos amp Ms Concepcion Gistau 1 Calibration is a b c d After introducing environmental conditions then calibrating the spirometer with a 3 L syringe the device corrects the deviation automatically Checking if temperature and pressure are measured Check if the spirometer is linear in all flows Verify if barometer is in a clean room 2 Validation Checking is a b d Checking the humidity of spirometer Recommended to do in all spirometer Verify spirometer linearity deviation and correcting the errors manually a and b 3 Some devices cannot be calibrated a b c d True some devices are calibrated and don t need it False all devices need to be calibrated Just once a week Some devices only need to be calibrated once a year 4 Actions to be taken in case of non credible results a b First call the company Change temperature and pressure 127 c Review and calibrate verify pneumotach d bandc 5 Quality control is a Calibrating with a 3L syringe at all flows in the spirometer b Review spirometer c Perform biological controls d Assess spirometer verify all flows and periodically perform biological controls 128
19. 3 Subsequent spirometry testing on each BioQC subject should fall within the 2 ranges for that subject The facility should perform troubleshooting if BioQC values fall outside of their acceptable ranges Weekly BioQC Testing 1 The BioQC subjects should perform spirometry procedures in the same way as a patient 2 For consistency BioQC subjects should ideally be tested a On the same spirometer b At the same day of month c At the same time of day 47 An adequate test requires a minimum of three acceptable FVC maneuvers and adherence to repeatability criteria e Repeatability is achieved when the difference between the largest and the next largest acceptable FVC and FEV is less than or equal to 150 mL The results for FVC and FEV1 do not need to come from the same maneuver e The best trial is chosen based on the largest sum of FVC plus FEV1 from acceptable maneuvers It is recommend that the BioQC subjects be tested weekly and should be recorded on the Spirometry Quality Control Program worksheets e Fill in the values generated by the BioQC subjects The average standard deviation SD and coefficient of variation CV will automatically be calculated e The CVs for FVC and FEV1 should be less than or equal to 3 e Confirm that the results fall within the acceptable ranges for this BioQC subject Determining the normal range for a biological control The person used as a biological control must be healthy and free of
20. 4 930 304 241 1 55 0 75 FEVIZF 78 16 99 28 127 0 99 28 79 49 51 02 25 29 p MMEF 3 00 377 1259 377 221 0 92 0 42 FEV6 2 78 PEF 8 47 463 54 6 463 3 25 9 17 1 92 MMEF 3 00 377 1259 377 221 0 92 0 42 FEF 50 3 81 3 81 220 1 25 0 34 FIF 50 FEZFIF 64 59 36 22 34 83 12 99 PIF Flujofvolumen WO 2 2 se a VBEex 0 07 0 07 0 03 0 04 0 01 Flow L s volume L de la espirometria forzada DE Biological Control BjpQC Testing A biological normal quality control BioQC refers to a healthy non smoking individual with normal and stable lung function who is tested on a regular basis as a control Frequently office and staff personnel are asked to perform this function The facility should identify two BioQC subjects It is recommended that al least two healthy non smoking individuals should be identified to perform spirometry testing to assess the overall operational status of the spirometry system Results are monitored to assess changes in equipment performance that may be undetected in routine calibration Establishing the BioQC Normal Range 113 Perform 10 replicates on each BioQC subject over a period of several days Ideally this should entail a single test performed each day however a maximum of 2 tests spread out within any single day e g morning and afternoon may be used Use the Normal Range Calculator to determine the acceptable ranges for each person This worksheet takes the average of the repl
21. 5 2013 8 06 01 CALVOL 5 20 1 b Volumen y Cabina AY He CO Jp Presi n Co 0 995 ass tent fe TT aan a 35 i505 Corex 0 962 esre was 5 aN oga ess ssf 25 isa j hood ox 13a 1373 waf 29 v4 corel 3 000 3000 1009 15 l in 504 de 101 1 108 7 9 57 paG 100 5 1083 9974 05 fas 90 93 sso 102 f i 1015 1818 ssf 2 0 004 pos 05 12 504 15 KY 20 las 1004 K s0 Y 35 04 0 50 4 0 30 20 4 0 00 10 2030 40 50 60 Expiration 0 0 00 L Inspiration 0 0 00 L ATS L Pneumo p Bomba 2 00 L Cero Om DES H Spiro b albrar Validar m aa How to check the accuracy of a flow spirometer Check the volume accuracy using a 3 00 liter calibration syringe every day before using the spirometer Select calibration check from the menu of the spirometer so that the software does not apply a BTPS correction factor to the results If the flow sensor is permanent and heated as in some older models check the manual to see if the heater should be turned off for at least 30 minutes before calibration checks If an unheated permanent flow sensor is used and it was recently cleaned be sure that it is completely dry and at room temperature before the calibration check Ifthe spirometer uses disposable flow sensors use a new flow sensor from each box of flow sensors for the calibration checks For calibration checks some flow spirometers require a spe
22. 5 40 Erratum Eur Respir J 1995 8 1629 American Thoracic Society Standardization of spirometry 1994 update Am J Respir Crit Care Med 1995 152 1107 1136 Miller MR et al Standardisation of spirometry ATS ERS task force standardisation of lung function testing Eur Respir J 2005 26 319 338 Multiple choice questions 3 What is the most important advantage of disposable consumables in spirometers a Accuracy b Price c Infection prevention When there is no 3L calibration syringe available what is another way to control the quality of your spirometer a biological controls b checking the repeatability of the patients tests c Auto zeroing before each test What are the most important features for your choice of spirometer a Stability hygiene and software version b Accuracy hygiene and stability c Price display and portability 95 Equipment name How many which parts do you have to Are they disposable assemble F yes no i yes no yes no z yes no Try to identify this spirometer it is measuring by 0 Rotating vane 0 Ultrasound 0 Pneumotachography 0 Other please specify iseeneses Strengths and weaknesses of this specific spirometer Strengths Weaknesses What are the possibilities of printing for this INStrUMENt ccccsessssseceeceesseeseessesseaeceeeeessesssesneseeaeeas What are the possibilities of downloading results b
23. ASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Miller M R R Crapo et al 2005 General considerations for lung function testing Eur Respir J 26 1 153 161 Miller M R J Hankinson et al 2005 Standardisation of spirometry Eur Respir J 26 2 319 338 Pellegrino R G Viegi et al 2005 Interpretative strategies for lung function tests Eur Respir J 26 5 948 968 ERS Lucky the French have a translation in Traduction frangaise des recommandations ATS ERS 2005 pour les explorations fonctionnelles respiratoires Volume 24 Issue 3 Part 2 Pages 4 160 March 2007 Revue des maladies respiratoires Revue des Maladies Respiratoires j a Standardisation de la spirom trie R n ERS And lucky Dutch also have a translation Vertaling Richtliinen ATS ERS In beheer van de NVLA zijn uit de serie TASKFORCE ATS ERS STANDAARDISATIE VAN LONGFUNCTIEONDERZOEK in het Nederlands vertaald Free download available at www nvla nl ESDL PART 1 MODULE 1 RESPIRATORY PHYSIOLOGY ANATOMY AND PATHOLOGY ERS Aims mechanics of tidal and maximal forced breathing limits of deep in and expiration several types of airway obstruction structure of airways and lung parenchyma Sn chest wall elasticity muscluar action pspiratory society every breath counts g Z 5 a Weib
24. ERS Verification Some devices cannot be calibrated Measured value must be within 3 of syringe volume 90ml for a 3L syringe Systems with software generated correction factors should be within range 0 97 1 03 3 ERS Biological control Subject must be healthy free of respiratory disease and have a stable lung function Record spirometry at the same time of the day for at least 10 days Calculate the mean for FVC and FEV1 Calculate 2 5 of the mean Normal range and 2 5 of the mean You can now use this person to check that the spirometer readings fall within this range ERS Prevention of infection transmission Wash hands prior to testing Depending on spirometer Use disposable bacterial viral filter Or use disposable flow transducer Or disinfect flow head between patients Wipe down the outside of the spirometer between patients Using filters does not eliminate the need for cleaning and decontaminating equipment ERS Rationale for regular cleaning Level of infection risk is low However Potential for transmission of upper respiratory diseases TB viral infections by direct or indirect contact Most likely surfaces for transmission are mouthpieces and proximal valves and tubing Increased awareness of hospital infection control issues ERS Quality control programme Manual of procedures Calibration and cleaning procedures Test performance procedures Calculations
25. ERS Reconstruction F V curve expiration flow isovelume flow effort independent pressure loss of muscle strength inspiration flow pressure curve flow volume curve 11 R aie Airways and lung parenchyma connective tissue cartilage smooth muscle alveolar walls loss alveolar septa ers_ Airway mechanics in lung emphysema expiration alveolus airway F V curve in lung emphysema y inspiration 12 GERS The limits of breathing maximal inspiration maximal expiration european respiratory society every breath counts ERS Maximal movements of the chest maximal inspiration maximal expiration TLC niveau CENO RV Aiy dd counts Low vital capacity restriction proportional pushing aside emphysema 13 ERS Limits of the vital capacity Pe cccccccccccccceeeeed lcoccccccccccccccoccce volume volume deep inspiration 4 visceral pleura lam e intrathoracic pressur airway closure ERS Respiratory pathology Main categories of obstructive disease Asthma COPD Chronic bronchitis Emphysema ERS Asthma Airway inflammation with variable airway obstruction and abnormal airway responsiveness to a variety of stimuli Often reversible airway obstruction spontaneously or induced by treatment 14 ERS COPD
26. ERS Spirogram Inspiration Expiration Back extrapolation If a patient is slow to start the expiratory manoeuvre the measure can be corrected by back extrapolation Time zero can be assessed by visual analysis and should be reported Most computerised spirometers correct automatically If machine does not have printout it can be difficult to assess quality of manoeuvre Back extrapolation Expired volume L 0 Extrapotated Jvolume time s 24 Back extrapolation Volume L b 5 am a Extrapolated Vatume 0 0 E 0 9 time Zoro 05 Tm lime 30c Environmental conditions e Environmental conditions have a significant effect on measuring lung volumes E g 5 liter in a spirometer room air of 22 C 5 46 liter in a lung body temp of 37 C Vv Parps Veres Parps ATPS Tarps Tarps Ambient temperature All measures of gas volumes should be reported at B T P S measuring temperature and barometric pressure Results should not relate to conditions in the measuring equipment ATPS Ambient temperature must be recorded with an accuracy of 1 C 17 C is the lower limit for ambient temperature unless manufacturer states otherwise 25 Ambient temperature Changes in spirometer temperature can be a source of variability The method used to calculate or estimate the BTPS factor can potentially introduce significant errors
27. EUROPEAN RESPIRATORY SOCIETY every breath counts ERS Annual Congress Barcelona 7 11 September 2013 Postgraduate Course 16 Spirometry knowledge and basic skills part 1 of the European spirometry training programme Thank you for viewing this document We would like to remind you that this material is the property of the author It is provided to you by the ERS for your personal use only as submitted by the author 2013 by the author Saturday 7 September 2013 14 00 17 30 Room 1 1 CC1 EUROPEAN RESPIRATORY SOCIETY every breath counts ERS Spirometry Training Programme This document provides a step by step guide for those who wish to fully complete the European Spirometry training programme Part and Part 2 PART 1 and the ONLINE KNOWLEDGE TEST Step 1 Attend the postgraduate course and educational skills workshop Step 2 Online test Each participant will receive a link to the online knowledge test after attending the postgraduate course and workshop Participants will be expected to complete the online MCQ test within 4 weeks of attending the course and will have a total of 3 attempts to complete the test All participants will be given access to the ERS spirometry website On this website participants will have access to content for each of the 8 modules as well as access to an online knowledge test in English Step 3 ERS certificate Part 1 of the ERS spirometry driving licence On successful co
28. ON 4 Calibration and quality control how to calibrate different devices and perform biological control procedures Definitions Calibration set of operations that establishes under specified conditions the relationship between values of quantities indicated by a measuring instrument or measuring system or values represented by a material measure or a reference material and the corresponding values realized by standards Quality control part of quality management focused on fulfilling quality requirements example ISO 9000 Quality management coordinated management activities to direct and control an Repeatability closeness of the agreement between the results of successive measurements of the same item carried out under the same conditions of measurement NOTE 1 Same conditions imply same method same observer same instrument same location same condition of use and repeated over a short space of time Reproducibility closeness of the agreement between the results of measurements of the same item carried out under changed conditions of measurement NOTE Changed conditions imply changes in the method of measurement observer instrument location conditions of use and time Example If a technician tests a subject several times this is looking at the repeatability of the test If the subject is then given a bronchodilator drug and tested again after 30 minutes one needs to know the reproducibility of the tes
29. PS 20lder models may not comply with the ATS ERS standard due to back pressure above specifications 3 ATPD is a modification since gas room air is partly saturated with water vapour ERS Spirometers What to look for Specifications ATS ERS specifications An absolute must Look for maximum volume back pressure and software performance Software Automatic check of start and end of test criteria and selection of best FEV and FVC Storing of all quality control data Linearization of Pneumotachograph signal ATPS BTPS conversion Can the accuracy and precision of time calculation be controlled a general problem Calibration Practicality Practicality Is the system easy to operate How many data entries has to be performed before you can measure Infection control cost of consumables Robustness Spirometer lifetime and costs ERS Mouthpiece tubing s nose clips and bacterial filters ERS Spirometer calibration syringes 3 The ATS ERS standard A 3 litre syringe with an accuracy of 15 mL or 0 5 of the full scale Calibration annually 32 ERS Thermometer hygrometer and barometer P hPa Lo http www dmi dk dmi index danmark vej Tobservationer vejrobservationer land htm The reference is A certified thermometer A certified barometer available at the web from the local Meteorological org A certified wet bulb thermomete
30. Part 1 theory only certificate of the ERS spirometry driving licence Part certifies that participants have the knowledge and understanding of spirometry in practice however are not yet considered competent to perform spirometry measurement Participants must be awarded their certificate before they can register for Part 2 of the training programme ERS SPIROMETRY WORKBOOK Step 1 When to complete the workbook All participants must fully complete the ERS spirometry workbook before their attendance on Part 2 of the European Spirometry training programme Step 2 Preparing participants on how to complete the workbook Participants will learn about the ERS spirometry workbook during the Part 1 training day Each participant will receive the template of the workbook and guidelines to complete the workbook Participants may also find support on how to complete this workbook on the ERS HERMES website under Activities W hermes ersnet org Step 3 Mentoring participants Participants who attend the Part 1 who would like to complete the ERS Spirometry workbook as well as Part 2 will be assigned a mentor who may assist them with this task ERS trainers will act as mentors to participants throughout the interim period between Part 1 and Part 2 training days All workbooks should be forwarded to assigned trainers ideally electronically at least 1 month before Part 2 training day Step 4 Marking Grading the ERS spirometry workbook If participan
31. QC record should have normal lung function Perform Spirometry daily on the same person over a period of at least two weeks at least 10 results of each in total should be collected Record the values in a table Calculate the mean value for the following values that you have recorded in your Quality Control record a The FEV b The FVC c The PEF iv Calculate an acceptable range by using 5 of the mean value of the measurements obtained 90 ERS 11 Patient Tests You must produce 10 technically acceptable spirometry traces for FEV1 FVC FEV1 FVC PEF You must include the height age diagnosis current drug therapy smoking history and date of test for each patient included in this section You must highlight which test results you would select for each patient from those performed Please ensure all patient data included in your portfolio is anonymised Failure to do so will constitute a breach of patient confidentiality and will result in an automatic fail being awarded You must include a signed witness statement from a senior member of staff at the place where you are employed indication that all of the traces included have been performed by you CENTRE DAAGNOETIC RESPRRATORE Funes RA MOR ERS 12 Problems Encountered During Testing You must provide 5 technically unacceptable spirometry traces FEV1 FVC FEV1 FVC PEF that you have recorded You should describe the problem that you encountered
32. a defined set of quality criteria or meets the requirements of the client or customer Is part of quality management focused on fulfilling quality requirements Quality management Coordinated management activities to direct and control an Repeatability Closeness of the agreement between the results of successive measurements of the same item carried out under the same conditions of measurement NOTE 1 Same conditions imply same method same observer same instrument same location same condition of use and repeated over a short space of time Reproducibility Closeness of the agreement between the results of measurements of the same item carried out under changed conditions of measurement NOTE Changed conditions imply changes in the method of measurement observer instrument location conditions of use and time Example If a technician tests a subject several times this is looking at the repeatability of the test If the subject is then given a bronchodilator drug and tested again after 30 minutes one needs to know the reproducibility of the test in order to make a decision on this comparison Verification Confirmation through the provision of objective evidence that specified requirements have been fulfilled NOTE Example verification of commercial information systems instruments and methods and calibration verification of results obtained on automated equipment Equipment Preparation Preparation of pulmonary function equipm
33. am describe the way in which your spirometer measures spirometry values For measurement we use a spirometer bemg a part of Medisoft Belgium The spirometer m use m our lab is a fow measunng device uung porumotachographs The volumes are obtamed by integration of flow eae E Mama do Sertcion pros E aos Donel ecu 87 ERS SPIROMETRY WORKBOOK SECTION B The following sections should contain evidence gathered by you during your working practice It must consist of traces witness accounts and logs of verification and cleaning 8 Calibration or verification of your spirometer 9 Quality assurance of your spirometry service 10 Cleaning of your spirometer 11 Patient tests 12 Problems encountered during testing SECTION B 8 Calibration or verification of your spirometer 9 Quality awurance of your spirometry service ERS 10 Cleaning This section consists of TWO parts a Provide a cleaning procedure for the spirometer in your care You must include your references for this and a copy of the work schedule to show that cleaning has been completed regularly Describe what contingency plans you have in place for dealing with potentially infectious patients e g suspected TB influenza etc ERS 10 Cleaning The 1 Abans do realitzar una espirometria Despr s do maniputar material Espirometria on traquoostomitzats Entre exploracions de diferents pacients En totes les actuacio
34. ation 1983 Measurement of atmospheric pressure 5 ed WMO Geneva 3 1 3 26 4 ISO IEC Guide 99 2007 International vocabulary of metrology Basic and general concepts and associated terms VIM 2007 Geneva International Organization for Standardization Factors that influence reference values ESDL module 3 4 ERS Reference equations are used for comparison of individual subjects with a healthy non smoking population measured under ideal conditions and according to standards agreed upon by the scientific communities Reference equations are usually linear expressions of the form y a Height m b Age years c There are separate equations for men and women These equations can only be used in adult subjects and are not valid for the growth period because they will overestimate their values Therefore special equations must be used in children As lung function depends on other factors than gender height and age there will be a scatter around the line described by the equation This scatter defines the residual standard deviation RSD which is a statistical term so that y RSD 1 64 will include only 5 of subjects with normal lung function ECSC Reference equations ERJ 1993 6 Suppl 16 5 40 Regression equation height in metros A age in yoars From ARTP Handbook in Spirometry 2nd edition Association for Respiratory Technology andlPhysiblogyo re a th ers The variability of normal lung volumes
35. cial adaptor that fits between the syringe and the flow sensor First fill the syringe with air completely then attach it firmly to the flow sensor and empty it smoothly and completely End the maneuver carefully to ensure that a soft click is heard meaning that the syringe was emptied completely Do not bang the syringe while emptying it to avoid damage Disconnect refill with air and then empty the syringe three times each time at a different speed First empty it in less than one second fast next in 2 or 3 seconds medium and the third time take about six seconds slow Count one one thousand two one thousand etc while emptying the syringe to gauge the speed of emptying The resulting FVC for all 3 of these maneuvers should be between 2 91 and 3 09 liters Record all three results on the daily worksheet or quality log 46 etria V5 1 0 justes Espirograma B al T eor Mejor Z B7P Medi Med2 Med3 Med4 Med5 Med6 Med7 Med8 Med9 M 7 3 06 3 03 3 05 2 96 Volume L FYC 418 3 06 FEV1 3 27 3 04 93 0 3 04 241 TSS 0 75 FEVIZF 78 16 99 28 127 0 99 28 79 49 51 02 25 29 3 00 Are aS 3 77 2 21 0 92 0 42 FEV6 2 78 PEF 8 47 4 63 54 6 4 63 3 25 9 17 1 92 MMEF 3 00 af 1259 rtd 2 21 0 92 0 42 FEF 50 3 81 3 81 2 20 1 25 0 34 FIF 50 FEZFIF 64 59 36 22 34 83 1299 PIF MVV Flujo volumen W it St Se 2 we VBEex 0 07 0 07 0 03 0 04 O0l Flow L s volume L 5 0 6 0 de la espirometria forzada oe
36. contraindications Spirometry can provide useful diagnostic and screening information but has some limitations ERS Indications To confirm or disprove lung disease suggested by symptoms signs or other abnormal laboratory findings Symptoms a Dyspnea wheezing b Cough phlegm production c Chest discomfort orthopnea Signs a Abnormal breath sounds b Decreased breath sounds c Chest wall abnormalities d Cyanosis finger clubbing Abnormal laboratory findings a Chest x ray CT scan b Arterial blood gases pulse oximetry ERS Indications To quantify the impact of known disease on lung function Pulmonary diseases a Chronic obstructive pulmonary disease b Asthma c Cystic fibrosis d Interstitial diseases Cardiac diseases a Congestive heart failure b Congenital heart disease c Pulmonary hypertension Neuromuscular diseases a Guillain Barr syndrome b Amyotrophic lateral sclerosis c Multiple sclerosis d Mystenia ERS Indications To measure the effects of noxious exposures Smoking Environmental pollutants Occupational agents To determine changes in lung function over time or following treatments Decline of lung function in disease Effects of respiratory drugs Effects of cardiac drugs Lung resection or transplant Respiratory rehabilitation ERS Indications To assess the risk for surgical procedures known to affect lung function Lung resection Thoracotomy Cardiac surge
37. ction assessment Unstead M Stearn MD Cramer D Chadwick MV Wilson R Aust N Z J Med 1999 Feb 29 1 9 14 A cost analysis of two approaches to infection control in a lung function laboratory Side EA Harrington G Thien F Walters EH Johns DP Aust N Z J Med 1999 Feb 29 1 3 4 Infection control in the respiratory laboratory risk costs expediency Pierce RJ J Hosp Infect 1995 Nov 31 3 205 10 The efficacy of filters used in respiratory function apparatus Leeming JP Pryce Roberts DM Kendrick AH Smith EC J Hosp Infect 1993 Mar 23 3 245 6 Use of filters for the control of cross infection during pulmonary function testing Leeming JP Kendrick AH Pryce Roberts D Smith D Smith EC Relevant Standards for Breathing System Filters BSF for Anaesthetic and Respiratory Use ISO 23328 1 200 Applicable to BSF used with a clinical breathing system It is not applicable to other types of filter e g those designed to protect vacuum sources or gas sample lines to filter compressed gases or to protect test equipment for physiological respiratory measurements Recommended reading l Pere tS ESDL Module 5 presentation Spirometry workbook example prepared for ESDL User manual for NDD EasyOne spirometer User manual for Micromedical spirometer 101 The use of placebo inhaler devices peak flow meters and inspiratory flow meters in clinical practice Practical Recommendations Each trust and health care o
38. cumstances such as 1 during industrial surveys or other studies in which a large number of subject manoeuvres are carried out the equipment s calibration should be checked more frequently than daily 8 and 2 when the ambient temperature is changing e g field studies volume accuracy must be checked more frequently than daily and the BTPS correction factor appropriately updated The accuracy of the syringe volume must be considered in determining whether the measured volume is within accep table limits For example if the syringe has an accuracy of 0 5 a reading of 3 5 is appropriate The calibration syringe should be stored and used in such a way as to maintain the same temperature and humidity of the testing site This is best accomplished by keeping the syringe in close proximity to the spirometer but out of direct sunlight and away from heat sources Quality control for flow measuring devices With regards to volume accuracy calibration checks must be undertaken at least daily using a 3 L syringe discharged at least three times to give a range of flows varying between 0 5 and 12 L s with 3 L injection times of 6 s and lt 0 5 s The volume at each flow should meet the accuracy requirement of 3 5 For devices using disposable flow sensors a new sensor from the supply used for patient tests should be tested each day For linearity a volume calibration check should be per formed weekly with a 3 L syringe to deliver
39. e largest sum of FEV1 and FVC Errors There are a number of problems you are likely to encounter when conducting spirometry Problems in performance of the test can be subject related for example graphs to illustrate those examples are presented in the ppt file Effort that is not maximal throughout Leaks Hesitation at the start of expiration Cough particularly during the first second of exhalation Glottis closure or tongue in mouthpiece etc For optimal quality control both flow volume and volume time displays are useful and operators should visually inspect the performance of each manoeuvre for quality assurance In particular for the assessment of acceptability the volume time curve allows to 1 evaluate any delay in the start of forced expiration and the amount of extrapolated volume 2 the fulfilment of end of test criteria plateau in change of volume expiratory time and 3 abrupt termination of expiration glottis closure mouthpiece obstruction The flow volume graph allows estimating 1 the magnitude of effort 2 the variability in effort and 3 the effect of coughing bouts during manoeuvre Reversibility testing 104 In some patients who may have airflow obstruction at baseline spirometry can be used to measure the response before and at various time intervals after the administration of inhaled bronchodilators either when given as a single dose or following a given trial period There is no general cons
40. e detect fewer abnormal lung functions In the US different prediction equations are used Hankinson s equations AJRCCM1999 159 179 187 An initiative is presently taken to collect multi ethnic reference values for the 3 95 year age range These are based on non linear analysis that dininishes the RSD and will be better for prediction of lung function abnormality very breath 36 Indications and contraindications of spirometry testing Prof Dr Jorg Daniel Leuppi Department of Internal Medicine University Hospital Basel Petersgraben 4 403 1Basel Switzerland jleuppi uhbs ch Summary As for any clinical test spirometry has specific reasons why it may be necessary These indications are many and form the basis of this teaching module Spirometry is generally well tolerated though it has few contraindications mainly pertaining to intercurrent illness An important respiratory condition where spirometry is contraindicated is pneumothorax as the maneuver could worsen this acutely Spirometry can provide useful diagnostic and screening information but has some limitations particularly its insensitivity to detect early stage restrictive disease 37 ESDL PART 1 MODULE 4 INDICATIONS AND CONTRAINDICATIONS OF SPIROMETRY ERS General considerations As any clinical test spirometry has specific reasons why it may be necessary These are called indications Spirometry is generally well tolerated though it has few
41. e filter as their resistance changes measured spirometric values see module 5 presentation The disinfection should be documented using a spirometer cleaning log An example of such a log is shown below Spirometer Cleaning Log The spirometer must be disassembled and cleaned as per the cleaning protocol By signing this log you are indicating that you have undertaken this in accordance with the protocol Date Name Signed Also other measures for safety can be undertaken this is usually defined at the level of hospital laboratory for example control bacterial swabs can be taken from spirometer equipment parts that are exposed to contact and or possible contamination As the workstation is to be equipped with two types of spirometers NDD and Micromedical MicroLab the presentation will include the use of disposable mouthpieces for NDD spirometer and also disassembling the turbine measuring head for cleaning References 100 MR Miller R Crapo J Hankinson et al General considerations for lung function testing Eur Respir J 2005 26 153 161 Respir Med 2003 Nov 97 11 1163 79 Infection control of lung function equipment a practical approach Kendrick AH Johns DP Leeming JP Respir Med 2006 May 100 5 946 50 Epub 2005 Oct 19 An audit into the efficacy of single use bacterial viral filters for the prevention of equipment contamination during lung fun
42. e point of maximal lung deflation expressed in Etsi Other definitions ERV Expiratory reserve volume volume change recorded at the mouth when taking a slow full expiration with no hesitation from a position of passive end tidal expiration i e FRC to a position of maximum expiration expressed in litres at BTPS Other definitions IC Inspiratory Capacity volume change recorded at the mouth when taking a slow full inspiration with no hesitation from a position of passive end tidal expiration i e FRC to a position of maximum inspiration expressed in litres at BTPS ERS Other definitions F E F 25 75 Forced Expiratory Flow 25 75 The mean forced expiratory flow between 25 and 75 of the FVC Expressed in litres at BTPS This index is taken from the blow with the largest sum of FEV and FVC It should be noted that it is highly dependent on the validity of the FVC measurement and the level of expiratory effort l Sia Spirogram Inspiratory Reserve Volume Inspiration Tidal volume Expiratory f Reserve Vol Functional Expiration Total Lung Capacit 6 liter Functional Residual Capacit 3 liter Residual Volume 1 8 liter Tidal Volume 0 5 liter Inspiratory Capacit 3 liter Inspiratory Residual Volume 2 5 liter Expiratory Reserve Volume 1 2 liter Vital Capacit 4 2 liter 23
43. e range 3 95 years The equations for caucasians are calculated using gt 57 000 spirometries gathered from healthy long life non smoking people ERS TASK FORCE Multi ethnic reference values for spirometry for the 3 95 yr age range the global lung function 2012 equations 75 FIXED VALUES VS LLN INTERPRETATION VENTILATORY DISORDERS An obstructive ventilatory defect is a disproportionate reduction of maximal airflow from the lun in relation to the maximal volume It implies airway narrowing during exhalation and is defined by reduced FEVI VC ratio below 5 percentile of a predicted value A restrictive ventilatory defect is characterised by a reduction in TLC below the 5 percentile of a predicted value and a normal FEV1 VC A mixed ventilatory defect is characterised by the coexistence of obstruction and restriction ERJ 2005 26 955 ERS INTERPRETATION RECITES iors vrs ete nd ter cngroes ERJ 2005 26 956 76 INTERPRETATION OBSTRUCTION is determined by spirometry when FEV1 F VC is below 5t percentile RESTRICTION cannot be determined by spirometry as it requires that TLC is below 5t percentile however it is very likely when FEV1 F VC is normal or elevated and F VC is decreased NORMAL SPIROMETRY Bez leku OBSTRUCTIVE PATTERN Bez beku 77 OBSTRUCTIVE PATTERN 2 RESTRICTIVE PATTERN Actual Pred ePred LLY SSD VIFV 9 26 79 06 RS TeS K 2 2
44. e test should explain the goal of the test and also demonstrate the manoeuvres and later during the actual measurement should stimulate the patient with the voice and gestures to obtain the best possible values Actual measurement There are three important steps FFF the subject has to follow in spirometry a Full inspiration b Forceful expiration c Full expiration Quality control of spirometry includes the assessment of acceptability within manoeuvre evaluation and repeatability between manoeuvre evaluation of the tests Recommended acceptability criteria on performing the test of forced expiration are the following 1 There is a good start of the test 103 2 Spirogram is free from artefacts continuous blow as fast and as hard as possible without cough variable effort and early termination etc 3 There is a satisfactory exhalation The rapid start is defined as a back extrapolated volume of lt 5 of the FVC or less than 0 15 1 whichever is greater Most devices offer a rapid computerised feedback to the technician if the start criteria are not met Inspection of the flow volume curve may be added to that PEF should be achieved with a sharp rise and occur close to the start of exhalation The end of test criteria are The subject cannot or should not continue further exhalation or The volume time curve shows an obvious plateau no change in volume 0 025 for gt 1 second or The subject has tried to exhale fo
45. early stages but it may not be sensitive to restrictive abnormalities before extensive damage has occurred ERS References 1 T J BARREIRO PERILLO An Approach to Interpreting Spirometry Am Fam Physician 2004 69 5 1107 1115 http www aafp org afp 2004 0301 p1107 html 2 AARC clinical practice guideline http www rcjournal com cpgs spirupdatecpg html 3 Gregg L Ruppel Manual of Pulmonary Function Testing 9th Edition 2009 4 General considerations for lung function testing ERS ATS Task Force Report on Standardisation of Lung Function Testing Eur Respir J 2005 26 153 161 5 Standardisation of spirometry ERS ATS Task Force Report on Standardisation of Lung Function Testing Eur Respir J 2005 26 319 338 6 NIOSH SPIROMETRY TRAINING GUIDE http www cdc gov niosh docs 2004 154c pdfs 2004 154c ch2 pdf 41 42 Quality Assurance Theory Felip Burgos Servicio de Pneumologia Hospital Clinic Villarroel 170 8036 Barcelona Spain fburgos ub edu Summary Definitions Calibration Set of operations that establishes under specified conditions the relationship between values of quantities indicated by a measuring instrument or measuring system or values represented by a material measure or a reference material and the corresponding values realized by standards Quality control OC Is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to
46. el 1984 S Zass usNvaL ERS Collapse of the left lung hest wall is springing aside ERS Muscles of respiration inspiratory muscles y i expiratory muscles neck musculature external intercostal internal intercostal diaphragm abdominal musculature breath counts ERS Maximal deep inspiration sternocleidomastoideus scalenis ERS f f Mechanics during spirometry volume eldsticity nedk musq amp abdominal muscles elasticity NV cliaphragin time Ee Airflow AP V R Poiseuille s law DS AP8nl TI alveolar pressure muscular strength elasticity airflow is dependent on resistance airway collapse airway obstruction obs Trumpet of funnel model sum of the transverse areas of each branching generation generation amount cross total section area a a a trachea o 1 3 cm 3 cm convection Lh x a segmental bronchi 3 20 0 15 cm 6 cm respiratory bronchiol 18 2 105 0 00195 cm 390 cm diffusion flow spee ERS Alveolar and intrathoracic pressure P PaP Pint th s Pow r P musc alv musc Piung 10 ERS Expiratory airway collapse pressure alveolus airway ERS ISO volume flow pressure 50 VC OEE flow expiration effect collapse pressure inspiration
47. ensus about the drug exact dose or mode of administering a bronchodilator but suggestions can be found in Miller et al 3 In summary there is a need to perform an adequate baseline spirometry as explained above then administer the drug using the method and dose agreed in your lung function lab and finally after a specific time interval record the post bronchodilator spirometry The first step in interpreting any bronchodilator test is to determine if any change greater than random variation has occurred There is no clear consensus about what constitutes reversibility in subjects with airflow obstruction In part this is because there is no consensus on how a bronchodilator response should be expressed the three most common methods of expressing bronchodilator response are per cent of the initial spirometric value per cent of the predicted value and absolute change Interpretation of bronchodilator test results is discussed more in ESDL Module 7 evaluation of spirometric results but the members of the ATS ERS taskforce recommend using the per cent change from baseline and absolute changes in FEV1 and or FVC in an individual subject to identify a positive bronchodilator response An increase in FEV1 and or FVC for more than 12 of the baseline value and more than 200 ml is considered a significant bronchodilator response 4 However expressing the change as a percentage of the baseline FEV1 exaggerates the response in those with the poo
48. ent prior to test performance is essential to obtain reliable data The following areas should be addressed e calibration and gathering equipment and supplies e selection of reference values 43 e complete required equipment checks as appropriate Proper equipment preparation is essential to obtain accurate and reliable test results Manufacturers instructions for use and ATS ERS statements need to be followed Reference values should be validated for the specific population Calibration vs Quality Control v Calibration adjusts the output of an instrument spirometer to match a known input v Quality control tests an instrument to verify that the output is accurate and or precise What Quality Control Is Quality control QC is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer QC is similar to but not identical with quality assurance QA Calibration of Spirometers yY Enter ambient temperature pressure and humidity for BTPS Correction if this isn t already done automatically by the spirometer Y The calibration pump should have a volume 3 liters bigger is better Volume 3to5 complete strokes in and out of a calibration pump v If the volume of the pump is measured after the calibration the result should lie between 97 and 103 of the declared volume This applie
49. es and example of how to log information J Lloyd Staffordshire United Kingdom W Tomalak Rabka Poland Workstation 3 Spirometry how to perform a spirometic test implement safety measures and select the best values J Kivastik Tartu Estonia J D Leuppi Basel Switzerland Workstation 4 Calibration and quality control how to calibrate different devices and perform biological control procedures F Burgos Barcelona Spain C Gistau Barcelona Spain Faculty disclosures Faculty contact information Answers to evaluation questions PAGE 93 99 103 107 121 123 125 Anatomy physiology and pathophysiology required for spirometry short summary Prof Dr Jorg Daniel Leuppi Department of Internal Medicine University Hospital Basel Petersgraben 4 403 1Basel Switzerland jleuppi uhbs ch Summary This module addresses the mechanics of tidal and maximal forced breathing the limits of deep in and expiration the different types of airway obstruction and the structure of airways and lung parenchyma Spirographic examples will be used to introduce the differences between obstructive lung diseases asthma and COPD and restrictive lung diseases A solid basic knowledge of respiratory anatomy will allow a deeper understanding of normal respiratory physiology and the situations where this is perturbed i e respiratory pathology ESDL PART 1 ERS All you need to know is in SERIES ATS ERS T
50. facturer instructions 5 Ensure the calibration results are within the required limits 3 5 or 2 895 liters to 3 105 liters 6 Maintain a copy of the calibration or calibration check in the log book ERS Calibration with 3 Liters Syringe v Objective Establishing a correspondence between standard measures syringe and measurement v Material 3 liter syringe standardized If not available 3L syringe better use syringe 2L than 1L v For flow measuring devices the calibration volume must be injected at different rates between 2 and12 L s v Volume accuracy should be within 3 5 at all flows y Calibration syringes must be kept at the same temperature and humidity as the spirometer Example Air from a 3 liter syringe was injected into the spirometer volume time curve producing the tracing below To meet the criterion of 3 of 3 liters a volume must fall between 2 91 3 09L The volume reads 2 93 liters so it is within the acceptable range If the baseline does not start at zero remember to adjust accordingly S o gt o i g lt gt Q D I no 2 e 3 p e O i Q 7 Y o o p 7 Hitt Sd Se See des tele Pls eee hs Se ee peer ees sees Pere aaa SS eele 2 3 A N _ Volume liters o 4 5 6 7 8 9 10 Time seconds N oe 45 Flow check at least three different flows range Calibracion de 07 0
51. for at least 30 minutes before calibration checks If an unheated permanent flow sensor is used and it was recently cleaned be sure that it is completely dry and at room temperature before the calibration check If the spirometer uses disposable flow sensors use a new flow sensor from each box of flow sensors for the calibration checks For calibration checks some flow spirometers require a special adaptor that fits between the syringe and the flow sensor First fill the syringe with air completely then attach it firmly to the flow sensor and empty it smoothly and completely End the maneuver carefully to ensure that a soft click is heard meaning that the syringe was emptied completely Do not bang the syringe while emptying it to avoid damage Disconnect refill with air and then empty the syringe three times each time at a different speed First empty it in less than one second fast next in 2 or 3 seconds medium and the third time take about six seconds slow Count one one thousand two one thousand etc while emptying the syringe to gauge the speed of emptying The resulting FVC for all 3 of these maneuvers should be between 2 91 and 3 09 liters Record all three results on the daily worksheet or quality log 112 etria V5 1 0 justes D Pre ER lt enter medication gt Espirograma gt Teor Mejor B P Medi Med2 Med3 Med4 Med5 Med6 Med Med8 MedS M 209 Vojurpe L FYC 418 306 733 306 303 3 05 2 96 FEV 1 3 27 30
52. he criterion for FEV1 and or FVC for positive bronchodilator response is a Increase gt 200 ml b Increase gt 12 from baseline c Increase gt 200 ml or gt 12 from baseline d Increase 200 ml and gt 12 from baseline 3 Obstruction in spirometric evaluation occurs when a FEV1 lt 80 pred b FEVI FVC lt 0 7 c FEV1 FVC lt lower limit of normal d Both FEV1 and FEV1 FVC lt lower limit of normal Please find all answers at the back of your handout materials 61 ESDL PART 1 MODULE 7 EVALUATION OF SPIROMETRY W TOMALAK ESDL TEAM MEMBER RABKA POLAND ERS PRESENTATION PLAN Acceptability and repeatabiltiy criteria Reversibility criteria Test result selection Best curve Reference values Advantages of LLN over predicted Normal pattern Obstructive pattern Restrictive pattern LITERATURE MR Miller et al General consideration for lung function testing ERJ 2005 26 153 161 MR Miller et al Standardisation of spirometry ERJ 2005 26 319 338 R Pellegrino et al Interpretative strategies for lung function tests ERJ 2005 26 948 968 62 BEFORE MEASUREMENT Check spirometer calibration ambient conditions Prepare the subject ask for important information smoking diseases medication used etc get patient s data including sex height age ethnicity describe the procedure in details if necessary demonstrate it to the patient inform the patient on commands del
53. icates and calculates two standard deviations SD which constitutes the normal range for this subject e Fill in the values generated by the BioQC subjects The average standard deviation SD and coefficient of variation CV will automatically be calculated e There should be a maximum of 10 between the highest and lowest FVC and FEV1 values e The calculated coefficient of variation CV should be 3 or less Subsequent spirometry testing on each BioQC subject should fall within the 2 ranges for that subject The facility should perform troubleshooting if BioQC values fall outside of their acceptable ranges 114 Weekly BioQC Testing 1 The BioQC subjects should perform spirometry procedures in the same way as a patient 2 For consistency BioQC subjects should ideally be tested a on the same spirometer b at the same day of month c at the same time of day 3 An adequate test requires a minimum of three acceptable FVC maneuvers and adherence to repeatability criteria e Repeatability is achieved when the difference between the largest and the next largest acceptable FVC and FEV is less than or equal to 150 mL The results for FVC and FEV1 do not need to come from the same maneuver e The best trial is chosen based on the largest sum of FVC plus FEV1 from acceptable maneuvers 4 It is recommend that the BioQC subjects be tested weekly and should be recorded on the Spirometry Quality Control Progra
54. ill change the outcomes 93 3 Ultrasonic Transducers located on either side of the spirette cavity emit and receive sound in alternating directions When gas flow is present in the tube a pulse that travels against the flow traveling upstream is slowed down and takes a longer time to reach the opposite transducer Conversely a pulse traveling with the slow traveling downstream is sped up and takes a shorter time to reach the opposite transducer eg NDD Easy One Strengths Very stable In addition the ultrasonic flow measurement is inherently independent of temperature humidity pressure and gas compositio Weaknesses When buying a spirometer make sure that the manufacturer or dealer guarantees that the equipment meets the specifications issued by the ATS American Thoracic Society and or the ECCS and ERS European Respiratory Society There also exist other types of spirometers eg hot wire anemometer and water seal spirometer these systems will not be discussed in this workshop as they re not often used outside the hospital laboratory Literature http www spirxpert com technical3 htm http www ersbuyersguide org respiratory actors distributors index pulmonary function category spirometry 94 Quanjer PhH Tammeling GJ Cotes JE Pedersen OF Peslin R Yernault JC Lung volumes and forced ventilatory flows Official Statement of the European Respiratory Society Eur Respir J 1993 6 suppl 16
55. ion testing it is instead advised to adapt the terminology agreed upon by ISO The International Organisation of Standardization in the International vocabulary of basic and general terms in metrology Calibration is defined as Set of operations that establish under specified conditions the relationship between values of quantities indicated by a measuring system or values represented by a material or a reference material and the corresponding values realized by standards Calibration is therefore not restricted to procedures where adjustments mechanical or electronic are performed Verification and validation is not defined by ISO and is therefore not used Verification Also called calibration check is often used to describe a measurement where no adjustments are performed Validation Is the same as verification eERS References ATS ERS Standard on spirometry and General considerations 2 World Meteorological Organisation 3 International vocabulary of metrology 1 Miller M R J Hankinson V Brusasco F Burgos R Casaburi A Coates R Crapo P Enright C P van der Grinten P Gustafsson et al 2005 Standardisation of spirometry Eur Respir J 26 319 338 2 Miller M R R Crapo J Hankinson V Brusasco F Burgos R Casaburi A Coates P Enright C P M Grinten P Gustafsson et al 2005 General considerations for lung function testing Eur Resp J 26 153 161 3 World Meteorological Organis
56. iration lt 25 ml and forced expiratory time greater than 6 seconds Those quality criteria are illustrated by examples showing bad performance Good spirometry implies that at least three acceptable manoeuvers should be recorded and reproducibility criteria should be met which are defined as the difference between the best and the second best value of FEV1 and FVC less than 150 ml Only technically acceptable spirometries can be interpreted When doing a bronchodilator test one should be aware that both spirometries pre and post should be technically acceptable and the bronchodilating agent should be properly delivered Then pre and 59 post values of FEV1 and FVC are analysed A positive response is achieved when the increase in postbronchodilator values is greater than 200 ml and 12 of prebronchodilator value Recorded best values are compared with reference values that are created using results obtained from the examination of a healthy subpopulation and have the form of equations relating respective parameters to sex age height and ethnic origin Application of reference values equation for a given patient yield to a predicted value the value expressed as predicted and also allows to calculate limits i e upper and lower limits of normal A recommended way of interpreting the results is to compare the measured value with the lower limit of normal LLN which is set at the level of 5 percentile and corresponds to a value of z
57. ivered during manoeuver ERS MEASUREMENTS OF THE FLOW VOLUME CURVE there are three distinct phases of FVC manoeuvre as follows 1 maximal inspiration 2 a blast of exhalation 3 continued complete exhalation to the end of test EOT ERJ 2005 26 p 323 ERS MEASUREMENTS OF THE FLOW VOLUME CURVE A good test is free of artefacts such as Cough during the first second of exhalation Glottis closure that influences the measurement early termination or cut off effort that is not maximal throughout leak obstructed mouthpiece A good acceptable test meets the start of test criteria SOT and end of test criteria EOT 63 START OF TEST CRITERIA A start of the manouver is determined by back extrapolation method Thus back extrapolated volume EV BEV should be less than 150 ml or 5 FVC whichever is greater PEF should be achieved with sharp rise and occur close to the point of maximal inflation i e the start of exhalation BACKEXTRAPOLATION s BEV values are usually calculated by spirometer s software ERS FAST RISE OF PEF PEF n Starto me exhalation 64 START OF TEST If the start of test is not maximal from the beginning of exhalation BEV increases PEF is shifted to the right on flow volume trace END OF TEST CRITERIA The subject cannot or should not continue further exhalation The volume time curve shows no change in volume lt 0 025 I
58. kku Po beku AFEV1 750 ml and 37 from the baseline 24 pred AFVC 320 ml and 10 from the baseline 11 pred Significant response 71 REFERENCE VALUES Spirometric data of a patient subject are evaluated by comparison with reference predicted values based on healthy subjects Firstly to check whether there is disturbance Secondly what is the degree of disturbance 40 Age years ry SAD gde Cvahte dite aan Retwerce Fewer Y um maun Precictan tih Poanende iea FET SC Denied bue Bates Teri Gender mate tensie c Inder eviye crv Oveptar C Predios ous W RE 455 ua 0 DOR wy Does net ment pane coy sinda NA met araid REFERENCE VALUES in Europe the combined reference equations published in the 1993 ERS Statement are often used for people aged 18 70 yrs with height range of 155 195 cm in males and 145 180 cm in females and those from Quanjer et al ERJ 1989 Supl 4 in pediatric ages ERJ 2005 26 950 REFERENCE VALUES The equations give expected values of spirometric indices in a healthy individual of the same sex age height and ethnic origin as tested patient Spirometric reference data follow normal gaussian distribution thus half of the healthy population is expected to have higher and half is expected to have lower values The lower limit of normal is set at 5th percentile which corresponds to a value of 1 645 SD standard de
59. known respiratory disease Record your own spirometry every day or that of a colleague if you have a respiratory condition at the same time of day on the same spirometer for 14 days You will need a minimum of 10 recordings Calculate the mean average for each spirometry parameter i e add up all the readings for that parameter and divide by the number of recordings e g mean 3 60 L Now calculate 2 5 of the mean i e 3 6 x 0 025 0 09 L Finally obtain the normal range for repeated measurements b Lump and subtracting this 2 5 value to the mean value i e 3 6 0 09 3 51 L and 3 6 0 09 3 69 L so the acceptable range for the person tested would be 3 51 L to 3 69 L You can now use this person to check that the spirometer readings fall within this range to verify the accuracy of your spirometer on a weekly _ basis SUMMARY Components of the spirometry QA program y Well chosen enthusiastic technologists v Trained and certified technologists v Happy technologists v Excellent spirometer used by everyone v Test session quality checks and messages v Daily 3 00 liter calibration checks v Central review and reporting of tech quality 48 SUMMARY Quality control programme Manual of procedures Logbook v Calibration and check data v Cleaning procedures v Test performance procedures x Calculations x Criteria of acceptability and repeatability v Reference values source y Action to be taken in case of
60. m worksheets e Fill in the values generated by the BioQC subjects The average standard deviation SD and coefficient of variation CV will automatically be calculated e The CVs for FVC and FEV1 should be less than or equal to 3 e Confirm that the results fall within the acceptable ranges for this BioQC subject 115 ERS ea SLUNG Determining the normal range for a biological control The person used as a biological control must be healthy and free of known respiratory disease Record your own spirometry every day or that of a colleague if you have a respiratory condition at the same time of day on the same spirometer for 14 days You will need a minimum of 10 recordings Calculate the mean average for each spirometry parameter i e add up all the readings for that parameter and divide by the number of recordings e g mean 3 60 L Now calculate 2 5 of the mean i e 3 6 x 0 025 0 09 L Finally obtain the normal range for repeated measurements by adding and subtracting this 2 5 value to the mean value i e 3 6 0 09 3 51 L and 3 6 0 09 3 69 L so the acceptable range for the person tested would be 3 51 L to 3 69 L You can now use this person to check that the spirometer readings fall within this range to verify the accuracy of your spirometer on a weekly basis european respiratory society every breath counts ERS SUMMARY Components of the spirometry QA program v Well chosen enthusiastic
61. me curve The features of these two presentations of spirometric data will be highlighted as well as the measurements which can be derived from them Methods for correction of spirometric data for patient factors such as slow starting or environmental factors such as ambient temperature will also be taught ESDL PART 1 MODULE 2 DEFINITIONS AND CALCULATIONS OF SPIROMETRIC INDICES Aim of presentation is e Overall to improve your knowledge of definitions used routinely when carrying out spirometry testing and to be able to identify where these measures are made Aim of presentation is Also to be able to know the differences between terms and to apply these terms when analysing test results 18 Background Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time The primary signal measured in spirometry may be volume or flow The test effort can be presented as a FLOW VOLUME LOOP or as a VOLUME TIME CURVE ERS Volume time curve NORMAL VOLUME TIME CURVE 8 5 D Sa as 5 32 gt 1 o C y a e 19 Time seconds ERS Flow volume loop Flow LiS vs Volume L 19 Volume Time Curve Flow Volume Curve ERS Expiratory limb of flow volume curve ERS Toa The main definitions e VC Vital Capacity the maximal volume of air exhaled steadily from full inspiration to maximal ex
62. mpletion of the test participants can generate an online certificate to confirm that they have passed the knowledge test and have been awarded Part 1 theory only certificate of the ERS spirometry driving licence ERS SPIROMETRY WORKBOOK All participants must fully complete the ERS spirometry workbook before attending Part 2 of the European Spirometry training programme PART 2 PRACTICAL TRAINING AND ASSESSMENT Participants will be required to attend Part 2 of the training programme which will be held in Barcelona 7 March 2014 This one course will cover modules in knowledge and competence in spirometry measurement Details on how to register will be distributed in October Those who successfully pass the practical assessment and ERS workbook will be awarded Part 2 of the ERS Spirometry Driving Licence knowledge and competence in spirometry measurement Postgraduate Course and Educational Skills Workshop Spirometry knowledge and basic skills European spirometry training programme Aims The aim of Part I Spirometry Knowledge and Skills is to ensure that participants acquire the knowledge and basic skills in spirometry best practice The training programme is designed to cover the theory required to pass the Level I knowledge test and equip participants with the skills needed to perform spirometric tests and successfully complete a Spirometry workbook including spirometry assignments calibration logs and a portfolio of spirometry tests
63. n respiratory society every breath counts EXAMPLE Air from a 3 liter syringe was injected into the spirometer volume time curve producing the tracing below To meet the criterion of 3 of 3 liters a volume must fall 110 between 2 91 3 09L The volume reads 2 93 liters so it is within the acceptable range If the baseline does not start at zero remember to adjust accordingly 6 5 Volume liters o 0 1 2 3 4 5 6 7 8 9 10 Time seconds ERS Flow check at least three different flows range seam Calibraci n de 07 05 2013 8 06 01 r p Volumen ty Cabina A a HeCO fp Presi n F CALVOLV5 20 1 Comil 0 996 0 998 1081 Conex 0 962 0970 1008 30 ON 0904 0588 sass a5 ox iais waf 29 T 15 0 Poet tt 08 Beet im o pa 100 9 108 6 9969 Expiration 0 0 00 L Inspiration 0 0 00 L ATS Pneumo g Bomba 3 00 L Cero 0m OEB Spiro Gy cal Validar m ea oO 2 ere european respiratory society every breath counts How to check the accuracy of a flow spirometer 111 Check the volume accuracy using a 3 00 liter calibration syringe every day before using the spirometer Select calibration check from the menu of the spirometer so that the software does not apply a BTPS correction factor to the results If the flow sensor is permanent and heated as in some older models check the manual to see if the heater should be turned off
64. ns de ter pia respiratoria ERS SPIROMETRY WORKBOOK SECTION B The following sections should contain evidence gathered by you during your working practice It must consist of traces witness accounts and logs of verification and cleaning 8 Calibration or verification of your spirometer 9 Quality assurance of your spirometry service 10 Cleaning of your spirometer 11 Patient tests 12 Problems encountered during testing ERS Calibration or Verification This section consists of TWO parts A short piece of written work must be submitted explaining why your spirometer must be calibrated or verified regularly and a description of how you would do this Produce a calibration verification record for your spirometer i If your spirometer produces a hard copy provide evidence of at least 20 calibrations or verifications performed by you These should be performed over a minimum of a one month period If your spirometer does not produce a hard copy design a system for recording your calibrations or verifications and record at least 20 results These should be performed over a minimum of a one month period 89 ERS il i R ERS Calibration or Verification e This section consists of TWO parts a Briefly explain the purpose of Quality Control in the context of a Spirometry service b Create a Quality Control record using either yourself or a member of your team The person used for your
65. o submitted MCQs Please find all correct answers in bold below POSTGRADUATE COURSE Quality assurance theory Dr Felip Burgos 1 a aes ae os ae 8 ae os Calibration is After introducing environmental conditions then calibrating the spirometer with a 3 L syringe the device corrects the deviation automatically Checking if temperature and pressure are measured Check if the spirometer is linear in all flows Verify if barometer is in a clean room Validation Checking is Verify spirometer linearity deviation and correcting the errors manually Recommended to do in all spirometer Checking the humidity of spirometer b and c Some devices cannot be calibrated Just once a week False all devices need to be calibrated True some devices are calibrated and don t need it Some devices only need to be calibrated once a year Quality control is Calibrating with a 3L syringe at all flows in the spirometer Review spirometer Assess spirometer verify all flows and periodically perform biological controls Perform biological controls Evaluation of spirometric results Prof Waldemar Tomalak 1 aoe aoc aoc TS Properly performed spirometry should include At least one acceptable manoeuver At least three acceptable manoeuvers At least five acceptable manoeuvers At least eight acceptable manoeuvers The criterion for FEV1 and or FVC for positive bronchodilator response is Increase gt 200 ml Inc
66. orded with a patient wearing indoor clothes and being without shoes There is no need to measure height of an adult patient if it was measured within 3 years For patients with a deformity of the thoracic cage the arm span can be used as an estimate of height Height and or weight are used in the calculation of reference values 6 Which of the statements about documenting relevant events that occurred during the spirometric assessment is INCORRECT a b c d It should be documented if the patient seemed not to properly understand the instructions given to him her It should be documented if the patient got so tired of testing that he she could not proceed with forced spirometry It should be clearly stated how long were the intervals between acceptable tests It should be stated in which position standing or sitting testing was undertaken 7 Which of the statements about the choice of bronchodilator is INCORRECT a b The choice of bronchodilator is a clinical decision depending on what the clinician wishes to learn from the test Reversibility testing can only be done using the bronchodilator which has not been used by that patient within 24 hours A lower dose of bronchodilator can be used if there is concern about any effect on the patient s heart rate or tremor You have to wait longer for the post bronchodilator spirometry when using the short acting anticholinergic agents than when using the short acting beta
67. ossibility of transmission of upper respiratory diseases enteric infections and blood borne infections through direct contact The most likely surfaces for contact are mouthpieces and the immediate proximal parts of valves or tubing There is also a possibility of transmission by indirect contact through aerosol droplets The hospital laboratory should define its own procedures on preventing and minimalizing the risks related to eventual transmission of infection Prevention of infection transmission to technicians 1 exposed to contaminated spirometer surfaces can be accomplished through proper hand washing and use of barrier devices such as disposable gloves To avoid technician exposure and cross contamination hands should be washed immediately after direct handling of mouthpieces tubing breathing valves or interior spirometer surfaces To avoid cross contamination reusable mouthpieces breathing tubes should be disinfected or sterilised regularly What concerns different types of spirometers manufacturers define the list of disinfecting agents to be used for disinfection Usually this is described in user s manual 99 Another way to minimize risks is to use disposable mouthpieces as in case of NDD EasyOne spirometer or anti bacterial filters as in case of MicroLab spirometers For detailed information see user s manual of the spirometer When using in line filters one should remember that the spirometer should be calibrated with th
68. ossible Ave 360 189 revit 309 247 FEVIVFV 0 792 0684 FEF2S 7S Ws 336 197 PEF L S 706 558 FET is 58 Evaluation of spirometric results Waldemar Tomalak Institute for TBC amp Lung Diseases Rabka Branch Poland wtomalak igrabka edu pl Aims The presentation presents information contained in module 7 of ESDL Part I Based on the spirometric standard published jointly by ERS and ATS 1 3 this presentation includes information on evaluating spirometric results during the measurements of forced manoeuver e acceptability and repeatability criteria e reversibility criteria for bronchodilator test e information on reference values and comparing the results with normal values e normal obstructive and restrictive patterns of spirometry e changes of spirometric indices over time Summary Spirometric results evaluation may be considered as a two step process The first part is concentrated on the analysis of performance and evaluating with respect to quality criteria defined by the standard 1 2 A good trial has to fulfil start of test criteria SOT and end of test criteria EOT Start of test criteria include fast rise of the flow to reach the value of peak expiratory flow fast with short time tPEF and the value of back extrapolated value being within defined limits less than 150 ml or 5 FVC End of test criteria include reaching the plateau on volume time curve defined as the change of volume in the last second of exp
69. piration not time dependent The air in the lung between residual volume and total lung capacity This is expressed in litres at BTPS body temperature and ambient pressure saturated with water vapour 20 The main definitions e FVC FORCED VITAL CAPACITY the maximal volume of air exhaled with maximally forced effort from a maximal inspiration expressed in litres at BTPS A slow or unforced VC or inspiratory vital capacity IVC manoeuvre may provide a larger and more appropriate denominator for calculation of the 0 1 O The main definitions FEV1 FORCED EXPIRATORY VOLUME IN ONE SECOND the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration expressed in litres at BTPS The main definitions FEV1 FVC Forced Expiratory Volume in 1 second divided by the Forced Vital Capacity or FEV1 ratio The percentage of the FVC that the patient can forcefully exhale in the first second of the FVC manoeuvre 21 The main definitions e P E F Peak Expiratory Flow the highest flow achieved from a maximum forced expiratory manoeuvre started without hesitation from a position of maximal inspiration Can be expressed in litres per second or litres per minute Other definitions P I F Peak Inspiratory Flow is the maximum inspiratory flow achieved from a maximum forced inspiration starting without hesitation from th
70. r In routine use of the electronic model and calibrate it against reference instruments ERS Stadiometer rH You can use an electronic device measuring temperature relative humidity and barometric pressure but then you have to calibrate it against a measurement traceable to a international standard e Measurement of stature Do it correct why not Harpenden Hightronic ERS Reference values The subject is instructed to relax the shoulders and the subject s head is placed in the Frankfurt plane which is the position where the line passing through the inferior margin of the left orbit and the upper margin of the left external auditory meatus is horizontal Use stadiometers with digital counters rapid and accurate Position measurands head in Frankfurt plane not Frankfort plane When we cannot compare a pulmonary function test with previous results we have to compare the results to a reference to estimate whether its normal or abnormal We are in a process where we are moving from the use of percent of predicted towards the use of standardized residuals or T scores when evaluating a lung function test Choose the best reference material which is not easy and use standardized residuals to decide whether a test is normal or not 33 ERS Metrology A note on calibration terminology Although it seems practical to use a descriptive terminology adapted to suit pulmonary funct
71. r 3 4031 Rabka POLAND wtomalak zpigichp edu pl Dr Jana Kivastik University of Tartu Department of Physiology Ravila 19 50411 Tartu ESTONIA jana kivastik ut ce EDUCATIONAL WORKSHOP Dr Brendan G Cooper Lung Function amp Sleep Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston B15 2WB Birmingham UNITED KINGDOM brendan cooper uhb nhs uk Mrs Jellien Makonga Braaksma Ekris 16A 3931 PW Woudenberg NETHERLANDS J Makonga meanderme nl Dr Jana Kivastik University of Tartu Department of Physiology Ravila 19 50411 Tartu ESTONIA jana kivastik ut ee Prof Waldemar Tomolak Institute for TBC and Lung Dis Dept Physiopathology of Respiratory System J Rudnik Str 3 34 700 RABKA POLAND wtomalak zpigichp edu pl Ms Concepcion Gistau Hospital Clinic CDR Villarroel 170 08036 Barcelona SPAIN cgistau clinic ub es 124 Dr Irene Steenbruggen Pulmonary Laboratory Isala klinieken loc W1 C2 PO box 10500 8000 GM Zwolle NETHERLANDS i steenbruggen isala nl Mrs Julie K Lloyd 118 Upper Way Upper Longdon Rugely WS15 1QD Staffordshire UNITED KINGDOM julie lloyd heartofengland nhs uk Mr Felip Burgos Servicio de Pneumologia Hospital Clinic Villarroel 170 08036 BARCELONA SPAIN fburgos ub edu Prof Dr Jorg Daniel Leuppi Department of Internal Medicine University Hospital Basel Petersgraben 4 4031 Basel SWITZERLAND jleuppi uhbs ch Answers t
72. r at least 6 seconds for at least 3 seconds in children lt 10 yrs The acceptability criteria must be applied before the reproducibility criteria Unacceptable manoeuvres should be discarded before applying the reproducibility criteria However failure to meet acceptability criteria does not mean that the manoeuvre is useless In these cases just reporting values of FVC and FEV 1 that the subject achieved could also be useful information The repeatability criteria are used as a guide to whether more than three acceptable FVC manoeuvres are needed The following reproducibility criteria are applied after three acceptable spirograms have been obtained 1 The two largest values of FVC must be within 0 150 1 of each other 2 The two largest values of FEV1 must be within 0 150 of each other 3 If criteria 1 and 2 are not met testing should be continued Eight manoeuvres are considered a practical upper limit for most subjects No spirogram should be rejected only because of its poor reproducibility provided three acceptable manoeuvres are obtained In these cases reproducibility of the test should be considered at the time of interpretation e g the FVC manoeuvre triggered a bronchospasm that prevented reproducibility Selecting the best values The largest FVC and the largest FEV1 should be recorded after examining the data from all the usable curves even if they do not come from the same curve FEF25 75 is taken from the blow with th
73. rease gt 12 from baseline Increase gt 200 ml or gt 12 from baseline Increase 200 ml and gt 12 from baseline Obstruction in spirometric evaluation occurs when FEV1 lt 80 pred FEV1 FVC lt 0 7 FEV1 FVC lt lower limit of normal Both FEV1 and FEV1 FVC lt lower limit of normal 125 EDUCATIONAL SKILLS WORKSHOP Workstation 1 Spirometers demonstration of how different types of spirometers work and how they are cleaned and maintained Mrs Jillian Makonga Braaksma amp Dr Brendan Cooper 1 What is the most important advantage of disposable consumables in spirometers a Accuracy b Price c Infection prevention 2 When there is no 3L calibration syringe available what is another way to control the quality of your spirometer a biological controls b checking the repeatability of the patients tests c Auto zeroing before each test 3 What are the most important features for your choice of spirometer a Stability hygiene and software version b Accuracy hygiene and stability c Price display and portability Workstation 3 Spirometry performing the test safety measures selecting the best values simulating errors Dr Jana Kivastik amp Prof Dr Jorg Daniel Leuppi 1 Which of the statements about the repeatability criteria and selecting the best values is CORRECT a Repeatability criteria are applied after four acceptable spirograms have been obtained b The two largest values of FVC and FEV1 m
74. rest FEV1 therefore some authors suggest to use a percentage of the predicted value instead as this adjusts for differences in lung size 5 References 1 Steenbruggen I et al Spirometry HERMES A European training programme and qualification in spirometry practice Breathe 2011 7 259 275 2 Miller MR et al General considerations for lung function testing Eur Respir J 2005 26 153 61 Indications and contraindications for spirometry equipment personnel and subject preparation are discussed in this paper Miller MR et al Standardisation of spirometry Eur Respir J 2005 26 319 38 This paper summarizes all the aspects of spirometric measurements Pellegrino R et al Interpretative strategies for lung function tests Eur Respir J 2005 26 948 68 Levy ML et al Diagnostic spirometry in primary care Proposed standards for general practice compliant with American Thoracic Society and European Respiratory Society recommendations Prim Care Respir J 2009 18 130 47 7 ERS spirometry video http www ers education org e learning procedure videos aspx ON Ov ASS e Evaluation 1 Which of the statements about the repeatability criteria and selecting the best values is CORRECT a Repeatability criteria are applied after four acceptable spirograms have been obtained b The two largest values of FVC and FEV1 must be within 0 15 L of each other c The largest FVC and the largest FEV1 from the same curve should be recorded after
75. rganisation in primary and secondary care must assess the potential risk of infection if placebo and spacer devices peak flow and inspiratory flow meters are used for multiple patients Infection risks may differ between primary and secondary care There needs to be a considered balance of the implications of the potential risks and the requirements of clinical practice with ownership of the risks accepted by the healthcare organisations The risks must be re assessed at appropriate intervals 1 The consequences of not teaching or checking inhaler technique or using a peak flow meter must be considered in light of national clinical guideline recommendations 2 Patients should be reminded to bring all their inhaler devices with them to each review appointment Handing a reminder slip to patients each time may be helpful 3 Standard principles of infection control should be applied This includes hand hygiene between patients 4 Placebo devices spacer devices peak flow meters or inspiratory flow meters should never be used for different patients if there is a known infection risk 5 As far as reasonably practicable all devices should be single patient use 6 If placebo devices are used for more than one patient they must be decontaminated each time they are used e Inhaler canisters and other devices that can be washed must be o Disassembled where possible o Washed thoroughly ideally in an ultrasound bath or according to guidelines NICE
76. rometry workbook ERS Disclosure Felip Burgos Stocks of Linkcare Health Solutions SL ERS European Spirometry Training Programme Part Il Knowledge and Competence in Spirometry Measurement Part Il of the training is a 7 10 hours training course which will focus on competency based training and will require participants to complete exercises and submit portfolios of spirometry tests Examination and the award of the European Spirometry Driving Licence Part Il will be dependent on a competency assessment 84 ERS Aims Aim of Part II Training The aim of Part of the training programme is to ensure that participants have acquired the skills and competencies to perform high quality spirometry tests The training programme will help participants complete a Spirometry workbook discussing common errors and how to problem solve issues relating to spirometry testing Part Il of the training programme will assist participants with the final preparations to carry out the practical assessment to be awarded the Level II European Spirometry Driving Licence ERS Participant Goals Participants will gain the specific knowledge skills and competencies required to perform high quality spirometry tests and cover the key areas of Spirometry practice Part Il Knowledge and Competence in Spirometry Measurement will ensure participants practice spirometry according to current international standards Following
77. ry Upper abdominal surgery To evaluate disability or impairment Social Security or other compensation programs Legal insurance or military evaluations Cardiopulmonary rehabilitation assessment Epidemiological or clinical research on lung health or disease ERS General considerations Performing lung function tests can be physically demanding for a minority of patients The requesting physician should be made aware that some circumstances could affect the reliability of spirometry measurements Forced expiratory maneuvers may aggravate some medical conditions contraindications therefore it might be advisable to delay lung function testing until they resolve ERS Contraindications Absolute Myocardial infarction within the previous month Relative Hemoptysis of unknown origin Pneumothorax Unstable cardiovascular status recent myocardial infarction or pulmonary embolus Thoracic abdominal or cerebral aneurysms Recent eye surgery Presence of any acute disease process that might interfere with test performance Recent thoracic or abdominal surgery dementia or confusional state ERS Limitations Test results can show abnormalities of lung function but these are not disease specific A reduction of vital capacity is regarded as a sign of respiratory disease but it cannot allow differentiation between restriction and obstruction Spirometry can detect obstructive abnormalities at relatively
78. s only if the BTPS correction is switched of All volumes are measured in liter BTPS That means the real volume inside the lung counts BTPS stands for Body Temperature ambient Pressure Saturated with water vapor ERS 3 Liter syringe The ATS ERS standard e A 3 litre syringe with an accuracy of 15 mL or 0 5 of the full scale e Syringes must be calibrated annually The syringe should be stored in the same room where calibration is performed and should not be exposed to sources of heat or cold You should check with a certified 3 L syringe the accuracy cold measuring volume is kept within the recommended range 3 Calibration syringes should be accurate to 15 ml or 0 5 of full scale and need checked periodically for leaks and check its stability Perform Calibration or Calibration Check 1 Set spirometer to Calibration mode or Calibration Check mode 2 If filters designed specifically for spirometry testing are used calibration or calibration checks should be done through the filter 3 Perform a calibration or calibration check using the validated 3 L calibration syringe according to the 2005 ATS ERS statement Standardization of spirometry see 44 references Pull the syringe handle out completely and push the 3 liter volume into the spirometer at the correct flow 4 Repeat the calibration or calibration check at least three separate times at three different flow rates as per manu
79. spiratory society every breath counts 109 Perform Calibration or Calibration Check 1 Set spirometer to Calibration mode or Calibration Check mode 2 If filters designed specifically for spirometry testing are used calibration or calibration checks should be done through the filter 3 Perform a calibration or calibration check using the validated 3 L calibration syringe according to the 2005 ATS ERS statement Standardization of spirometry see references Pull the syringe handle out completely and push the 3 liter volume into the spirometer at the correct flow 4 Repeat the calibration or calibration check at least three separate times at three different flow rates as per manufacturer instructions 5 Ensure the calibration results are within the required limits 3 5 or 2 895 liters to 3 105 liters 6 Maintain a copy of the calibration or calibration check in the log book ERS Calibration with 3 Liters Syringe v Objective Establishing a correspondence between standard measures syringe and measurement v Material 3 liter syringe standardized If not available 3L syringe better use syringe 2L than 1L v For flow measuring devices the calibration volume must be injected at different rates between 2 and12 L s y Volume accuracy should be within 3 5 at all flows vy Calibration syringes must be kept at the same temperature and humidity as the spirometer iik PG europea
80. t in order to make a decision on this comparison Verification confirmation through the provision of objective evidence that specified requirements have been fulfilled NOTE Example verification of commercial information systems instruments and methods and calibration verification of results obtained on automated equipment 107 Equipment Preparation Preparation of pulmonary function equipment prior to test performance is essential to obtain reliable data The following areas should be addressed e calibration and gathering equipment and supplies e selection of reference values e complete required equipment checks as appropriate Proper equipment preparation is essential to obtain accurate and reliable test results Manufacturers instructions for use and ATS ERS statements need to be followed Reference values should be validated for the specific population Reference Application of a Quality Management System Model for Respiratory Services Approved Guideline Second Edition Clinical and Laboratory Standards Institute NCCLS HS4 A2 Vol 26 No 15 Vol 2 No23 Calibration vs Quality Control v Calibration adjusts the output of an instrument spirometer to match a known input Y Quality control tests an instrument to verify that the output is accurate and or precise What Quality Control Is Quality control QC is a procedure or set of procedures intended to ensure that a manufactured product or performed ser
81. t that may be assessed during the practical test prior to the exam Step 3 During the assessment Participants will be assigned an examination time of 30 minutes during the Part 2 training day During the assessment examiners will use the completed ERS spriometry workbook as a reference as well as conducting a practical on spirometry technique Participants should be familiar with all of the modules covered in Part 2 of the European Spirometry training programme as all elements may be included within the practical assessment Participants will have the possibility to resit the examination onsite with a different examiner if they fail on their first attempt Step 4 Providing feedback Following the practical exam all participants will receive the ERS spirometry practical_examination and feedback form This document will be shared with the participant no longer than 1 month following the practical assessment Step 5 Awarding of the European Spirometry Driving Licence Part 2 Those who successfully pass the practical assessment and ERS workbook will be awarded Part 2 of the ERS Spirometry Driving Licence knowledge and competence in spirometry measurement All certificates will be sent from the ERS headquarters in Lausanne Switzerland A register of successful participants will be available on the ERS HERMES website W hermes ersnet org 83 ESDL Posgraduate Course PG 16 Overview of Part Il completion and submission of the ERS spi
82. technologists v Trained and certified technologists v Happy technologists v Excellent spirometer used by everyone v Test session quality checks and messages v Daily 3 00 liter calibration checks v Central review and reporting of tech quality aft european respiratory society every breath counts SLUNG 116 ERS SUMMARY Quality control programme Logbook y Calibration and check data v Cleaning procedures v Test performance procedures y Calculations y Criteria of acceptability and repeatability v Reference values source v Action to be taken in case of panic values v Hardware and software upgrades version and data of change v Preventive maintenance service v Internal audit BUNG european respiratory society every breath counts References Eur Respir J 2005 26 319 338 DOI 10 1183 09031936 05 00034805 CopyrightOERS Journals Ltd 2005 SERIES ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Number 2 in this Series Standardisation of spirometry M R Miller J Hankinson V Brusasco F Burgos R Casaburi A Coates R Crapo P Enright C P M van der Grinten P Gustafsson R Jensen D C Johnson N Macintyre R McKay D Navajas O F Pedersen R Pellegrino G Viegi and J Wanger 117 i ih ha F Calibration is the procedure for establishing the relationship between sensor determined values of flow or volume and
83. the actual flow or volume A calibration check is different from calibration and is the procedure used to validate that the device is within calibration limits e g 3 of true If a device fails its calibration check then a new calibration procedure or equipment maintenance is required Calibration checks must be undertaken daily or more frequently if specified by the manufacturer The syringe used to check the volume calibration of spiro meters must have an accuracy of 15 mL or 0 5 of the full scale 15 mL for a 3 L svringe and the manufacturer must provide recommendations concerning appropriate intervals between syringe calibration checks Users should be aware that a syringe with an adjustable or variable stop may be out of calibration if the stop is reset or accidentally moved Calibration syringes should be periodically e g monthly leak tested at more than one volume up to their maximum this can be done by attempting to empty them with the outlet corked A dropped or damaged syringe should be considered out of calibration until it is checked Quality control for volume measuring devices The volume accuracy of the spirometer must be checked at least daily with a single discharge of a 3 L calibrated syringe Daily calibration checking is highly recommended so that the onset of a problem can be determined within 1 day and also to help define day to day laboratory variability More frequent checks may be required in special cir
84. three relatively constant flows at a low flow then three at a mid range flow and finally three at a high flow The volumes achieved at each of these flows should each meet the accuracy requirement of 3 5 118 Pulmonary Function Testing Jack Wanger Pulmonary Function Testing A Practical Approach Third Edition Jones amp Bartlett Learning 2012 Copyrighted Material CHAPTER 1 Forced Spirometry and Related Tests Introduction 1 Physiology 2 Spirometry Instrumentation 7 Spirometry Testing Techniques 24 Calculations and Reporting Results 36 Reversibility Testing 50 Basic Elements of Interpretation 52 Special Considerations 55 Maximum Voluntary Ventilation 56 Peak Expiratory Flow Rate Monitoring 57 Infection Control 58 Case Presentations 59 vyvvvvvyvvvvvvyvy Self Assessment Questions 66 Introduction Forced spirometry often referred to as spirometry is an essential component in the medical evaluation of patients complaining of shortness of breath It is also widely used to evaluate the beneficial effects and adverse reactions of therapeutic interventions and to monitor the effects of environmental and occupational exposures In addition forced spirometry is used in disability impairment evaluations in preoperative assessments and to monitor lung function over time Spirometry has shown considerable growth in the past 30 years for several reasons a published standards and testing guidelines b impro
85. tient if it was measured within 3 years For patients with a deformity of the thoracic cage the arm span can be used as an estimate of height Height and or weight are used in the calculation of reference values Which of the statements about documenting relevant events that occurred during the spirometric assessment is INCORRECT a b c d It should be documented if the patient seemed not to properly understand the instructions given to him her It should be documented if the patient got so tired of testing that he she could not proceed with forced spirometry It should be clearly stated how long were the intervals between acceptable tests It should be stated in which position standing or sitting testing was undertaken Which of the statements about the choice of bronchodilator is INCORRECT a b The choice of bronchodilator is a clinical decision depending on what the clinician wishes to learn from the test Reversibility testing can only be done using the bronchodilator which has not been used by that patient within 24 hours A lower dose of bronchodilator can be used if there is concern about any effect on the patient s heart rate or tremor You have to wait longer for the post bronchodilator spirometry when using the short acting anticholinergic agents than when using the short acting beta 2 agonists Please find all answers at the back of your handout materials 106 EUROPEAN RESPIRATORY SOCIETY WORKSTATI
86. trasound flow sensor Pitot tube Hot wire anemometer Spirometers Pocket spiro Opening membrane pneumotach i w Fleisch pneumotach E 32 Rotating vane Lilly pneumotach ERS ery breath counts Metrology Measurement terminology Precision 29 ERS ATS ERS specifications for spirometers 2005 France 6 ieee ea ye ESE Test Range secwracy TPS Pew range Tees Rewstarce ae us ae preasa ERS Spirometer requirements summary Spirometers must be able to accumulate volume 2 15 s Measuring volume 2 8 liter BTPS Accuracy of reading at least 3 or 0 05 liter with flows from 0 14 liter s Total resistance of airflow at 14 l sec should be less than 1 5 cm H O Ls 0 15 kPa Lt s With all filters tubing etc in place filters may change in resistivity due to moisture Up to 8 FVC measurements in 10 min with above criteria ERS ATS ERS Specifications for scale factors 2005 uy 8 3 Recommended minimum scale factors for time volume and flow on graphical output Parameter Instrument display Hardcopy graphical output Resolution Scale Resolution Scale required factor required factor Volume 0 050 L 5 mnt 0 025 L 10 mml Flow 0 200 L s 2 5mm L s 0 100 Ls 5 mm L7 s Time 02s 10 mm s 02 s 20 mm s the corect aspect ratio for a flow versus volume display is two units of flow per one unit of volume 30 Use fixed 2 1 scale flow l s i
87. ts have failed the workbook they may be allowed to attend Part 2 and have the opportunity to take part in the practical assessment All participants workbooks must be submitted and graded within 6 weeks after Part 2 Participants will fail to receive their Part 2 certificate if they have not successfully completed the workbook Step 5 ERS support ERS will provide support to participants with this process and all questions may be directed to hermes ersnet org 82 PART 2 PRACTICAL TRAINING AND ASSESSMENT Step 1 Attending the Part 2 training day Participants will be required to attend Part 2 of the training programme which will cover modules in knowledge and competence in spirometry measurement Step 2 Preparing for the practical assessment The practical assessment will be organised during Part 2 of the spirometry training day The ERS workbook is intended to assist participants to prepare for the practical assessment This process will take no more than 30 minutes and participants will receive immediate feedback from their examiner Participants are assessed on the practical procedure of spirometry as well as communication and professionalism All performance criteria are listed on the marking sheet which is available on the ERS HERMES website W hermes ersnet org Participants will be fully informed on what to expect during the practical assessment and will receive all necessary information on the test process and the modules and conten
88. tween the results of successive measurements of the same item carried out subject to all of the following conditions same method same observer same instrument same location same condition of use and repeated over a short space of time In previous documents the term reproducibility was used in this context and this represents a change towards bringing this document in line with the ISO ERJ 2005 26 154 REPEATABILITY CRITERIA The difference between best and the second best value of FEV1 lt 150 ml and The difference between best and the second best value of FVC lt 150 ml ERS MEASUREMENT OF FLOW VOLUME CURVE PROCEDURE PERFORM MANOEUVER w IS THE MANOEUVER ACCEPTABLE Y Vv HAVE WE 3 ACCEPTABLE MANOEUVERS OR 8 IN TOTAL Y NZ N STORE ARE THE RESULTS INTERPRET _ REPEATABLE ERS 5 i En I a a es oC EA EE M OE T m SA n aia a a a a i Se Tee Three acceptable i manoeuvers Please note values of BEV FET and tPEF in the SELECTION OF THE BEST CURVE After having three acceptable manouevers Check repeatability for FVC and FEV1 Calculate FEV1 FVC from the highest values obtained Select the manoeuver with the highest sum of FEV1 and FVC all other indices i e flows are taken from that manouever Print result 69 ERS Se Sas Sa SE rst p ji ji ne Tc eC ce T a es ec M Check repeatability
89. ust be within 0 15 L of each other c The largest FVC and the largest FEV1 from the same curve should be recorded after examining the data from all the suitable curves d Eleven manoeuvres are considered a practical upper limit for most subjects 2 The flow volume graph allows assessment of all of the following EXCEPT a The variability in effort b The magnitude of effort c The effect of coughing bouts during manoeuvre d Mouthpiece leaks 3 Which of the statements about preparation of subject is INCORRECT a Itis preferable to avoid smoking within at least one hour of testing b Itis preferable to avoid performing vigorous exercise within 4 hours of testing c It is preferable to avoid wearing clothing that substantially restricts full chest and abdominal expansion d The decision to avoid bronchodilators depends on the reasons why the spirometry was ordered 4 Which of the statements about the correct position to perform spirometry is INCORRECT a Testing should be done in the standing position b Correct posture is with chin slightly elevated and neck extended c Mouth should be put firmly around the mouthpiece the tongue should be out of the mouthpiece d Dentures should be left in place if they are not loose 126 e A nose clip should be used or the subject can pinch his her nostrils with fingers 5 Which ofthe statements about height and weight measurement is INCORRECT a b c d Height and weight are rec
90. ved spirometers and software c evi dence that both patients and physicians have inaccurate perceptions of the severity of airflow obstruction d evidence that history taking and physical examination by themselves are not Copyrighted Material 119 120 Faculty Disclosures Mr Felip Burgos owns stocks of Linkcare Health Solutions SL 121 122 Faculty POSTGRADUATE COURSE Dr Brendan G Cooper Lung Function amp Sleep Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston B15 2WB Birmingham UNITED KINGDOM brendan cooper uhb nhs uk Mr Felip Burgos Servicio de Pneumologia Hospital Clinic Villarroel 170 8036 Barcelona SPAIN fburgos ub edu Mrs Julie K Lloyd 118 Upper Way Upper Longdon Rugely WS15 1QD Staffordshire UNITED KINGDOM julie lloyd heartofengland nhs uk Mrs Jellien Makonga Braaksma Ekris 16A 3931 PW Woudenberg NETHERLANDS J Makonga meanderme nl Ms Concepcion Gistau Hospital Clinic CDR Villarroel 170 8036 Barcelona SPAIN cgistau clinic ub es Dr Irene Steenbruggen Pulmonary Laboratory Isala klinieken loc WI C2 PO box 10500 8000 GM Zwolle NETHERLANDS Lsteenbruggen isala nl Prof Dr Jorg Daniel Leuppi Department of Internal Medicine University Hospital Basel Petersgraben 4 34 700 Basel SWITZERLAND jleuppi uhbs ch Prof Waldemar Tomalak Institute for TBC and Lung Dis Dept Physiopathology of Respiratory J Rudnik St
91. ver time are more likely to signal a real change in lung function than two measurements When too many indices of lung function are tracked simultaneously the risk of false positive indications of change increases Clinical interpretation of serial tests should not be based solely on the coefficient of repeatability but also on the clinical findings ERJ 2005 26 962 ACKNOWLEDGMENTS J Leuppi ESDL TEAM MEMBER for sharing examples used in this presentation 80 Overview of part II completion and submission of the ERS spirometry workbook Felip Burgos Servicio de Pneumologia Hospital Clinic Villarroel 170 8036 Barcelona Spain fburgos ub edu ERS Spirometry Training Programme Information Handbook BACKGROUND INFORMATION This document provides a step by step guide for those who wish to fully complete the European Spirometry training programme Part and Part 2 Training is divided into two parts and all participants must complete and be assessed on Part 1 Knowledge assessment of modules 8 of the training programme via an online knowledge test Workbook Assignments and portfolio of spirometry tests to assess participants understanding and application of spirometry in practice assess Module 8 Part 2 Practical assessment to assess competence in spirometry measurement including modules 1 8 of the training programme Spirometry HERMES Training Process Part Spirometry Kno
92. viation If the distribution is skewed the lower limit should be estimated with nonparametric technique ERJ 2005 26 949 95th percentile N 50th percentile 5th percentile reference value 1 645 SD 1 645 SD 73 REFERENCE VALUES So using reference values one can calculate the predicted value and the value of lower limit of normal LLN Assumption that a decrease in major spirometric parameters such as FEV1 VC FEV1 VC and TLC below their relevant 5th percentiles is consistent with pulmonary defect is a useful simple approach in clinical practice n contrast with a fixed value of 0 7 for FEV1 FVC the use of 5th percentile does not lead to overestimation of the ventilatory defect in older people ERJ 2005 26 955 ECCS REFERENCE VALUES 6 60H 1 81H 0 016A 2 00 1 05H Ph Quanjer et al ERS REFERENCE VALUES EXAMPLE OF CALCULATION e Caucasian males 30 yrs 180 cm 70 yrs 180 cm FEV1 LLN 4 38 3 54 80 8 3 22 2 38 73 9 FVC LLN 5 25 4 25 80 9 4 21 3 21 76 2 FEV1 FVC LLN 81 8 70 0 74 6 62 8 74 LIMITATIONS Reference equations are valid for a given age and height range Lower limits of normal for spirometric indices decrease with age so using a fixed value may lead to errors GLI2012 Recently a report from the ERS Task Force Global Lung Initiative has been published presenting new multi ethnic reference values for the ag
93. vice adheres to a defined set of quality criteria or meets the 108 requirements of the client or customer QC is similar to but not identical with quality assurance QA Calibration of Spirometers yY Enter ambient temperature pressure and humidity for BTPS Correction if this isn t already done automatically by the spirometer v The calibration pump should have a volume 3 liters bigger is better v Volume calibration 3 to 5 complete strokes in and _ out of a calibration pump v If the volume of the pump is measured after the calibration the result should lie between 97 and 103 of the declared volume This applies only if the BTPS correction is switched of all volumes are measured in liter BTPS That means the real volume inside the lung counts BTPS stands for Body Temperature ambient Pressure Saturated with water vapor ERS 3 Liter syringe The ATS ERS standard e A 3 litre syringe with an accuracy of lt 15 mL or 0 5 of the full scale Syringes must be calibrated annually The syringe should be stored in the same room where calibration is performed and should not be exposed to sources of heat or cold You should check with a certified 3 L syringe the accuracy cold measuring volume is kept within the recommended range 3 Calibration syringes should be accurate to 15 ml or 0 5 of full scale and need checked periodically for leaks and check its stability re STUNG european re
94. view of the patient issues around spirometry This should include the following a A brief discussion of the contraindications to performing spirometry This should state the absolute contraindications e g current chest infection and the relative contraindications b A brief description of the instructions that the patient should receive PRIOR to having spirometry performed e g withholding bronchodilators smoking etc 7 With the aid of a diagram describe the way in which your spirometer measures spirometry values You should state the measurement principle of your device e g is it flow measuring or volume measuring device ERS 5 A copy of your local protocol for performing spirometry including the guidelines that you use Normativa SEPAR Espirometria Francisco Garcia Rio Myriam Calle Felip Burgos Pere Casan F lix del Campo Juan B Galdiz Jordi Ginert Nicol s Gonzalez Mangado Francisco Ortega y Luis Puente Maestu 6 An overview of the patient issues around spirometry As the patients are referred to the lab by doctors they use comtraindicatons Isted an the standard Prior to the testing the patients are imstructed according to the protocol used in the lab This includes the demonstration of speroenetre Indications and comtraindica 6 INDICACIONES CONTRAINDICACIONES Y COMPLICACIONES 6 1 Indicaciones Evaluar la ad respwatona arte ta res ci ERS 7 With the aid of a diagr
95. volume I AE 1 2 Correct ratio flow volume 2 units of flow versus 1 unit of volume ERS ATS ERS Specifications for quality control 2005 a y 8 3 Summary of equipment quality contro Test Minimum interval Action Volume Daily Calibration check with a 3 L syringe Leak Daily 3 cmH 0 0 3 kPa constant pressure for 1 min Volume linearity Quarterly 1 L increments with a calibrating syringe measured over entire volume range Flow linearity Weekly Test at least three different flow range Time Quarterly Mechanical recorder check with stopwatch Software New versions Log installation date and perform test using known subjec ERS Spirometers summary Type Advantages Disadvantages Rolling seal Accurate and precise reliable Size price cleaning Not affected by gas composition Wedge bellows Accurate and precise reliable Size cleaning BTPS conversion of Not affected by gas composition volumes is problematic Inspiratory tests are impractical Pneumotachograph Accurate and precise reliable Only linear over defined range portable Affected by gas composition Calibrated with gas at ATPD and measures expiration at BTPS and inspiration at ATPD Rotating vane Accurate and precise reliable Not affected by gas composition Ultrasound Accurate and precise reliable Needs to be zero flow Not affected by gas composition internal thermometer needed to calculate gas volume at BT
96. w a x u O r 0 1 2 Expired volume litre Quanjer Ph et al ERJ 1993 78 ERS Causes of obstructive lung disorders Chronic or reversible airway obstruction Examples chronic obstructive bronchitis emphysema bronchial asthma Causes of restrictive lung disorders Intrapulmonary disorders Examples lung fibrosis pneumectomy lobectomy atelectasis Extrapulmonary disorders Examples cooperation failure diaphragm paralysis kyphoscoliosis ERS CHANGES IN LUNG FUNCTION OVER TIME THE FLETCHER DIAGRAM Never smoked or not susceptible to smoke Stopped at age 45 Smoked regularly and susceptible p gt to its effects Disability Stopped at age 65 a N G o 2 amp bd 5 gt ir Age years ERS CHANGES IN LUNG FUNCTION OVER TIME by 8 8 b3e Reported significant changes in forced vital capacity FVC forced expiratory volume in one second FEV1 mid expiratory flow MEF 25 75 and carbon monoxide diffusing capacity DL CO over time FVC FEV MEF25 75 DLCO Within a day Normal subjects COPD patients Week to week Normal subjects COPO patients Year to year ERJ 2005 26 961 ERS CONSIDERATIONS FOR INTERPRETATION IEEE Summary of the considerations for the interpretation of change in lung function Be aware of possible significant changes in lung function parameters over time table 12 Multiple measurements o
97. wledge and Skills Part Il Knowledge and competence in Spirometry Measurement Prerequisites A spirometry tests online modules y V Knowledge Practical based test Assessment 4 4 European European Spirometry Driving Spirometry Driving Licence Level Licence Level I 81 PART 1 and the ONLINE KNOWLEDGE TEST Step 1 Access to the ERS spirometry website Each participant will be provided with an individual access code for 12 months to the ERS spirometry website Participants must have access to this website at least 1 month before they attend Part 1 of the training programme On this website participants will have access to module content for each of the 8 modules as well as access to an online knowledge test in English These codes provide individual access for each participant All questions on access codes can be directed to hermes ersnet org Step 2 Online test Participants will be expected to complete an online MCQ test within 4 weeks of attending the course and will have a total of 3 attempts to complete the test Each participant will receive a link to this online knowledge test after completion of Part 1 of the European Spirometry training programme Step 3 Awarded ERS certificate Part 1 of the ERS spirometry driving licence On successful completion of the test participants can generate an online certificate to prove that they have passed the knowledge test and have been awarded
98. y mail link ccccccccesscccssseceesseecssecceessecesseeeeeseecees Start the instrument and study the program what do you see Disassemble the instruments how would you clean the different parts What do you expect to be the price of this instrument Approximately euro What are the possibilities of downloading results by maillik A ees i eae tires Start the instrument and study the program what do you see Disassemble the instruments how would you clean the different parts What do you expect to be the price of this instrument Approximately 97 98 Infection and control Waldemar TOMALAK Institute for TBC amp Lung Diseases Rabka Branch Polands wtomalak igrabka edu pl Mrs Julie K Lloyd 118 Upper Way Upper Longdon Rugely WS15 1QD Staffordshire United Kingdom julie lloyd heartofengland nhs uk Aims Aim of the presentation on Workstation 2 is to present information on possible hazards related to infection control procedures including General information on the risks Some information on how to perform and document cleaning and disinfection Demonstration of disassemble spirometer parts to cleaning and disinfection Summary The goal of infection control is to prevent the transmission of infection to patients subjects and staff during pulmonary function testing 1 Although there are not too many documented cases of infection transmission the risk is quite real There exist p
99. zation of lung function methodology He is co organier of an annual S Postgraduate Course Pulmonary Function Testing sponsored by the Department of Medicine University of Barcelona atso supported with by the European School of Respiratory Medicine of the European Respiratory Society He was a Research Fellow at Harbor UCLA in Torrance He has been involved in the Spanish Project for Standardization of Lung Function Tests He is aiso a reguiar 3 Your Spirometry Training Course ERS 4 Background information about your work environment The lab is located in a separate building within the institute It performs spirometric exams for the Clinics of the institute and for outpatient department Patents for lung function are referred by physicians working in different cinics of the institute other hospitals and primary care centers The Respiratory Diagnostic Center CDR is performing spirometry lung volumes by pietimography and also He dilution DLCO compliance trans ckaphragmatic pressures PO FOT RINT Mathacholine Manitol cardio pulmonary exercise test CEPT 6 MWD multiple inert gas exchange technique MIGET and arterial blood gases Our Respiratory Diagnostic Center is performing 2800 86 ERS SPIROMETRY WORKBOOK SECTION A 5 A copy of your local protocol for performing spirometry including the guidelines that you use This should be a document that you or your team use and not a photocopy of guidelines 6 An over
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