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ARIC Manual 4 - CSCC - The University of North Carolina at Chapel

1. 10 TEMPERATURE 23 Centigrade or the last entered value will appear Change by typing in the new value DO NOT PRESS DELETE OR BACKSPACE Before leaving INF the technician should verify that the name and the I D number entered match those on the participant s folder 7 2 Editing Information If a mistake was made when entering the above information use the arrows on the right side of the keyboard cursor pad to move the cursor to the ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 30 Patient Information New Data Date Name Technician Age Sex Height 01 29 87 SMITH JOHN 031 56 M 160 Time 09 40 ID Number W101234 Ethnic Group O White l Black 2 Amer Ind Alaskan 3 Asian 0 Temperature C or F 25 Enter DATA Use up arrow to edit Figure 8 INF Screen ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 31 position which needs correcting To correct the error begin typing the information The balance of the line will disappear after the first character is typed Press ENTER to complete the typed line Press the space bar to return to the pulmonary MENU To change participant information values after patient testing has been completed send a copy of the report to the Pulmonary Function Reading Center indicating the changes that need to be made A new report will be generated at the Pulmonary Function Reading Cen
2. 2 Race Option 2 will ask for race in the information INF program White Black American Indian Alaskan Native Asian Pacific Islander and will reduce predicted spirometry values by 12 for non whites ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 A 91 4 COLOR 1 Monochrome 2 Color Option 2 requires user to have color graphics board with composite monitor for graphic displays Option 2 displays graphics on a color monitor 5 INSPIRED EXPIRED LOOP l Inspired Expired Loop 2 Expired Only Option 2 only allows plotting of expired curve of FVL 6 NORMAL INF 8 PARTICIPANT STORAGE ON DRIVE C For dual drive system configure for storage on drive B and insert STORAGE disks in drive B For XT system configure for storage on disk C or D 9 PRINTER 1 IBM or Oki 92 2 C ITOH B W black ribbon only 3 C ITOH Color four color ribbon 4 C ITOH Color Blue DS four color ribbon printing data sheet in blue only Epson JX B W black ribbon only Epson JX Color four color ribbon IBM or C ITOH EP B W black ribbon only IBM or C ITOH EP Color four color ribbon only IBM or C ITOH EP Color Blue DS four color ribbon printing data sheet in blue only XO 00 410 Un 8 o o 12 INSPIRED to EXPIRED LOOP MUST BY 80Z 1 Inspired to Expired Loop must be 80Z 2 Inspired to Expired Loop must be 85Z 3 Inspired to Expired Loop must be 90 4 Inspired to Expired Loop must be 95Z
3. Print record identifier and compare with transmittal forms Backup files received from Field Centers Store original and standardized curve data Calculate and store indices of flow and volume from individual spirogram records Format indices of standardized flow and volume for transmittal to Coordinating Center Make copies of files sent to Coordinating Center Statistical quality control of grouped field center data Compare sex and race specific regressions on age and height of healthy non smoking participants between centers with the same center on previous occasions and with predicted values Reports Prepare weekly report for Field Centers see Appendix I page 84 regarding a Status of data received 1 number of records on disk 2 number of paper tracings received 3 number of acceptable records and percent of total ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 73 ARIC Pulmonary Reading Center Pulmonary Function Procedures cont acceptability and quality 1 number of unacceptable tracings for each acceptability criteria 2 percent of quality code agreement 3 identify tracings that disagree on quality code sample tracings sent see pages 86 89 identify tracing date technician participant 2 comments on technician s measurements and quality of test 3 compare pulmonary reading center s measurements with field centers measurements 4 compare pulmonary reading center s mea
4. Ratio of FIVC FEVC must be a minimum of 80Z for inspiratory flows to be calculated Less than 80 constitutes submaximal effort 13 FVL VT on DATA SHEET 1 No graph on Data Sheet FVL HiRes on Data Sheet FVL Color on Data Sheet FVL VT on Data Sheet VT HiRes on Data Sheet VT Color on Data Sheet VL VT Color on Data Sheet Norm WM ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 A 92 Note Color selection will also display on color monitor if screen display only is selected Do NOT select option 7 for Epson or C ITOH EP Color graphs selection for final report will print in graphics mode on black ribbon printers 14 A D ADDRESS Do not change A D address without consulting S amp M Instrument Company pre set to 640 18 EXTRAPOLATE FEF 25 75 ENTERING FIELD CENTER NAME 1 The field center name which appears on the final Participant Data Sheet is entered only once during the configure CON program 2 After all of the CON options are selected and entered press ENTER The screen will show the last entered name and will prompt for changes Enter the name of the field center and respond Y when asked OK TO SAVE DATA Y N The program then loads and displays the main MENU or INDEX 3 Entering INI initialize if the configure has been performed it is necessary to lock in the field center name which has just been entered To do this wait for the main Pulmonary Menu to display on the
5. Trial 6 Actual Flow L S B FVC 3 93 ET FEV 1 1 3 53 FEV 1 FVC X 90 FEV 3 1 3 93 FEV 3 FVC X 100 FEV 6 1 3 93 6 FEV 3 FEV 6 X 100 FEF25 75 l s 4 63 4 PEFR Ms 9 39 i FEF25 Is 6 94 FEF50 Ms 5 01 FEV75 Ws 2 17 4 2 3 4 Vol Questionable END EXPIRATORY time Trial 6 not accepted FVC FEV1 less than best 3 Press SPACE BAR or ESC Figure 21 FVL Screen for Questionable END ESPIRATORY Time ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 46 Error Acceptability Code asking the participant to maximally inspire and then to immediately begin forced expiration without letting air leak out first See Figure 15 Note The ATS has revised this criterion to 5 and the software now checks for a 5Z leak although the screen message still shows 10Z 3 Error Response Interrupted 5 Participant failed to complete a smooth forced expiration maneuver Repeat the study instructing the participant to continue the maneuver without removing the mouthpiece from the mouth or without coughing 4 Questionable END EXPIRATORY TIME 6 The end of test criteria as recommended by the A T S were not met The vital capacity may be underestimated and flow rates may be overestimated and or incorrect for that participant See Figure 21 8 6 2 Reproducibility A spirogram is considered reproducible if the second best FVC is within 5 of the best FVC and
6. 10 2 Cleaning the Internal Parts The Survey II spirometer should be cleaned weekly You will need a small screwdriver in order to remove the spirometer bell 1 Unplug the spirometer power cord and disconnect the cable leading from the base of the spirometer to the rear of the computer Remove the kymograph drum by simply lifting it off of its base Detach the breathing tube 2 There are two vertical guide rods located on either side of the spirometer At the top of the rod holding the linear potentiometer is a small plastic stop which prevents the spirometer bell from being raised to a position which could prove damaging to the potentiometer rod Unscrew and remove this stop Note POSITION OF THE BELL STOP When in place the bell stop should be located on the same side as the potentiometer It should also be positioned so that the bell stops when the recording pen reaches the 8 liter mark on the kymograph 3 Loosen the potentiometer clamping set screw at the side of the potentiometer clamp to allow the potentiometer rod to slide freely out of the clamp Do not remove the rod from the body of the potentiometer 4 At the top of the spirometer bell across from the potentiometer clamping piece is the recording pen holder screw Loosen and remove this screw At this point you should be able to raise the spirometer bell free of the guide rods 5 Remove the spirometer bell from the rest of the apparatus being careful not to squeeze t
7. Expected Actual Deviation 57 57 526 533 995 996 1464 1467 1934 1937 2403 2410 2872 2879 3341 3347 3810 3810 Position Position Position Position Position Position Position Position Position io C0 7 1 O0 Q1 4 WP ee OA WWE 0 Intercept 2 77 Slope 1 0006 STD DEV 3 28 Mean 1937 Range 3753 Zero 57 Linearity 0 087 W C Lin 0 197 Press SPACE BAR to continue Figure 3b Linearity Results ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 MO IS Page 21 Figure 4a Opening 3 liter syringe past the l liter mark Figure 4b Move silver collar to the l liter position and tighten Figure 4c Close up of placing the collar at the l liter position ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 22 SPROKETER Figure 4d Attach Rudolph valve to the short tubing and the spirometer breathing tube SPiRO HETER Figure 4e Attach the 3 liter syringe to the short tubing ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 23 6 Press SPACE BAR 7 OPEN the Rudolph valve turn clockwise then OPEN the syringe fully draw ONE LITER of air into the syringe 8 CLOSE the valve turn counterclockwise then CLOSE the syringe push this volume into the spirometer 9 Press SPACE Bar 10 Repeat steps 7 through 9 until eight 8 liters have been pushed into the spirometer The screen shown in Figure 3b wil
8. Failure of printer card 7 Fault light on printer on ARIC PROTOCOL 4 Pulmonary Function Assessment a No paper in printer b Printer internal failure Version 1 7 7 10 87 B Troubleshooting Guide Software Problem Program disk does not load Screen displays the C gt character No disk will load S amp M or other source Read error on video screen No volume and or flow when spirometry is performed 1 3 A 89 Cause Solution System is in IBM DOS system Type Go press ENTER Use back up disk may be disk media failure poor copy or electrical interference destroyed some or all of disk Hardware failure have IBM serviced IBM turned on with disk drive open Close drive door and re start the system Check to see if cable from PSII interface to spirometer is connected Spirometer output functional electric spirometers must be on and in operate mode A D interface requires service C Troubleshooting Guide Calibration and Testing Problem Low water level Faint pen line Failure of pen to rest on baseline Time check outside acceptable range Leak Alinearity Volume calibration error Error entering participant information Unacceptable Spirometry Technique Illustrations Reading Center criteria ARIC PROTOCOL 4 See See See See See See See See See See See Pulmonary Function Assessment Cause Solution Section 6 2 Sectio
9. 436 437 438 445 446 447 454 455 456 463 464 465 472 473 474 481 482 483 490 491 492 496 497 498 499 500 504 505 ARIC PROTOCOL 4 Pulmonary Function Assessment FVC liters Status Code FEV liters Stat s Code FEV liters Status Code FEV liters Status Code FEV liters Status Code FEV FEVC Status Code FEV 5 FVC Stalis Code FEV FVC Status Code FEV FVC Status Code Date of last calibration Status Code PEFR Status Code FEF Stat s Code FEF Status Code FEF Statis Code FEF Staf s Code Time of last calibration Status Code Acceptability Code acceptable l not acceptable 9 unable to assess acceptability Status Code Time to best FVC seconds Status Code Page 68 Version 1 7 7 10 87 506 507 508 509 510 Page 69 Technician s Quality Code 1 5 l spirograms last at least 6 seconds tracings reproducible smooth with continuous transition of slope 2 spirograms last at least 6 seconds tracings reproducible but irregular 3 spirograms last less than 6 seconds tracings reproducible smooth with continuous transition of slope spirograms last less than 6 seconds tracings reproducible but irregular 5 spirograms not reproducible Status Code Reading Center Quality Code computer generated l spirograms last at least 6 seconds tracings reproducible smooth with continuous transition of slope 2 spirograms last at least 6 second
10. ARIC protocol requires five trials for each subject Coach the participant through both maximal inspiration and smooth continuous forced expiration Place an identifying number near the kymograph tracing of each trial Testing will be stopped after five trials At least two reproducible maneuvers out of three acceptable maneuvers should have been performed Attach labels containing ID number name and date to the tracing Also record time temperature and quality code on the tracing ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 12 The technician enters an overall quality code for the acceptable tracings at the completion of testing Print the pulmonary function report At a later date this report will be reviewed by the ARIC clinic physician and then filed in the participant s file 5 1 4 Data Management The test results are automatically saved to two files one on the hard disk and the back up on the archive floppy disk Enter ID number name date and time from the printed pulmonary function report onto the inventory file disk of each participant tested This inventory file disk informs the ARIC Coordinating Center that a pulmonary function study has been performed on this participant At the end of the testing day store the floppy disk turn off the computer and detach and clean the spirometer hose 5 2 Weekly Procedures l Print a listing of the contents of the hard disk and the archive f
11. Aste AUS Du ws ate osa secas acer Computer Software eee Wis oid SU STR SUE er e e pir LR IESUS Sy D General Information Before Beginning Procedure e 8 Main Pulmonary Menu Description esee EEEE T 8 Protocol Summary exsue es ete ores IR E T eee Daily ProcedurteS cose o aer rwr rh err rt ah esr Bee 9 ES 11 Weekly Procedures TERTE TEET A E EET ETA 12 Manual Back up Procedures for Recording Raw Pulmonary Function Data PW TEE Tre e rae Ra eaa me sme es abd Instrument Preparation and Calibration eee es evel Power up tbe Computer eee n E E E r Water Level Temperature Paves aan tas ATE TUE ES Spirometer Hose e eeeeeeeeee eee hon PONES Pen Check yas y ly ara race enn eig ep raices Pale se a er oes LO Chart Paper and Baseline Checks DE EEE 6 Time and Leak Checks eee eee eene nnns n nnn 16 Linearity Check oa er RR ee aes hand De te ai ee pP ee Eo Volume Calibration Check ccc cc ccc cee eee eee rer n nn n nn 23 Participant Information eee eee enn nn nn nnn 29 Entering Information on Computer eese eee eee enn nn ead Editing Informati n 2 2 ete dx Il Se oe RR 4e alus 29 Participant Spirometry Testing sia sopa ad zs dA Explanation of the Procedure Date tis a s yahelerelsne fa severas e E EEE d d Post
12. Management Procedures at Pulmonary Function Reading Center eee rng AP gata n 61 11 5 File Format for Pulmonary Function Test Records eee 63 11 6 Coordinating Center s Response to Pulmonary Function Reading Center cece cere reece eer eee ht n n n 68 12 Terms and Symbols cece reece cece hn 12 1 General dr SHS Bee we ee E oa ees PEETER eere 74 12 2 Equations he ca Wess t erg e ee 80 fal ese e sede he a ce ENS 74 13 AppendiceS 0 2 96 E p Ee REIR eVvIr e sues due ies Noe e E EA eus 76 I Sample Reports eec eeeeeee reete ht htnc 76 II Troubleshooting cee ee eee eee n nnn img Via ties e e 87 III Configuration Set up Routine cese ee cee eee cece eens 89 IV Prediction Equations EO ENTE n sedo EE 9 dui ere ora Rc S bra fanis e 92 V Equipment Supplies and Vendors eee eee eee nnn 94 VI References ETERNI ee re i E ELA EON 96 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 1 l INTRODUCTION 1 1 The Importance of Pulmonary Function Testing in ARIC Follow up surveys of community populations in England 1 2 Denmark 2 and the United States 3 5 have shown that impaired ventilation spirometry is associated with increased death rates age specific mortality over periods of 4 to 15 years Impaired pulmonary function has been found to be a risk factor for mortality even afte
13. but not of mucus hypersecretion to mortality from chronic lung disease Am Rev Respir Dis 1983 128 491 500 Cole TJ Gilson JC Olsen HC Bronchitis smoking and obesity in an English and Danish town Male deaths after a 10 year follow up Bull Eur Physiopathol Respir 1974 10 657 667 Higgins MW Keller JB Predictors of mortality in the adult population of Tecumseh Respiratory symptoms chronic respiratory disease and ventilatory lung function Arch Environ Health 1970 21 418 424 Ferris BG Higgins ITT Higgins MW Peters JM Chronic nonspecific respiratory disease in Berlin New Hampshire 1961 1967 A follow up study Am Rev Respir Dis 1973 107 110 122 Petty TL Pierson OJ Dick NP Hudson LD Walker SH Follow up evaluation of a prevalence study for chronic bronchitis and chronic airway obstruction Am Rev Respir Dis 1976 114 881 890 Beaty TH Cohen BH Newill CA Menkes HA Diamond EL Chen CJ Impaired pulmonary function as a risk factor for mortality Am J Epidemiol 1982 116 102 113 Beaty TH Menkes HA Cohen BH Newill CA Risk factors associated with longitudinal change in pulmonary function Am Rev Respir Dis 1984 129 660 667 Tockman MS Khoury MJ Cohen BH The epidemiology of COPD in Chronic Obstructive Pulmonary Disease 2nd ed Petty TL Ed Marcel Dekker New York 1985 pp 43 92 Ostler DV Gardner RM Crapo RO A computer system for analysis and transmission of spirometry waveforms using volume
14. disagree Washington Co MD Date 07 17 1987 Quality codes l ou A not Spirograms last at least 6 seconds tracings reproducible smooth with continuous transition of slope Spirograms last at least 6 seconds tracings reproducible but irregular Spirograms last less than 6 seconds tracings reproducible smooth with continuous transition of slope Spirograms last less than 6 seconds tracings reproducible but irregular Spirograms not reproducible Flow volume loop not stored Calculation of acceptability and quality codes has been done on the following Technician Participant Date Acceptable Reading Field Center Center Quality Quality Code Code 031 PARTICIPANT NAME W139447 07 08 1987 No 5 5 W560 Acceptability code s 3 4 006 PARTICIPANT NAME W139766 07 08 1987 No 1 l W561 Acceptability code s 4 006 PARTICIPANT NAME W139973 07 09 1987 Yes l 1 W562 026 PARTICIPANT NAME W140071 07 09 1987 No 5 2 W563 Acceptability code s 5 031 PARTICIPANT NAME W140005 07 09 1987 Yes 1 1 W564 031 PARTICIPANT NAME W140018 07 09 1987 Yes 1 1 W565 006 PARTICIPANT NAME W140188 07 10 1987 Yes 1 1 W566 031 PARTICIPANT NAME W140170 07 10 1987 Yes 1 l W567 031 PARTICIPANT NAME W140220 07 10 1987 Yes 1 1 W568 ARIC PROTOCOL 4 Pulmonary Function Testing Version 7 7 10 87 A 83 ARIC Quality Control Report for Randomly Selected Spirograms in Washington County Maryland Date of Test 07 08 87 TECHNICIAN 026 PARTICIPAN
15. if the second best FEV is within 5 of the best FEV Note The best FEV and FVC need not come from the same test and need not come from the best test highest sum of FEV FVC 8 6 3 End of Participant Testing Testing will be stopped by the technician after 5 trials when two error free reproducible maneuvers out of three acceptable maneuvers have been performed If after five maneuvers these conditions have not been met testing should continue for up to 8 trials If the subject refuses to continue with the required number of trials this should be noted directly on the chart paper tracing 8 6 4 Quality Codes After the last trial pressing the F9 key will identify the three best Spirograms best sum of FEV and FVC These spirograms should be given an overall quality code by the technician according to the following criteria ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 47 Table 1 Quality Codes for Spirograms Quality Duration of Smooth and Continuous Code of Spirogram Reproducibile Transition of Slope 1 2 6 seconds yes yes 2 2 6 seconds yes no 3 lt 6 seconds yes yes 4 lt 6 seconds yes no 5 any duration no any condition 8 6 5 Labelling the Tracing At the end of a participant test attach labels containing ID number name date time quality code and temperature to the tracings The technician should verify that this information is correctly recorded on the label 8 6 6 End o
16. is not slipping on the kymograph drum or that the kymograph drum is not slipping on its support Repeat test twice If still unacceptable call the W E Collins Co for repair Notify the Pulmonary Function Reading Center and mark tracings that Time axis incorrect Note If any leak is detected the operator will determine whether the leak is in the breathing tube the internal tube or in the spirometer bell a Disconnect the breathing tube from the spirometer b Raise the bell halfway and insert a 7 solid stopper into the metal breathing tube connector at the front of the spirometer Observe the reading on the kymograph drum where the recording pen touches the paper c Place the weight on top of the spirometer bell wait for five minutes 20 rotations then observe the kymograph reading If the reading does not go down in this period then you know that the leak was in the breathing tube If however the reading does go down then the leak is in the internal tube or in the Spirometer bell d Reach underneath and inside the spirometer and disconnect the internal tube from the topmost internal port Raise the bell halfway and insert a 7 solid stopper into this topmost internal metal tube connector e Again place the weight on top of the spirometer bell and run the kymograph at the fast speed Wait for five minutes 20 rotations then observe the kymograph reading If the reading does not go down in this period then you know th
17. liters Equations 1 BTPS Correction Factors Factor to Convert When Gas Temperature Water Vapor Vol to 37C Sat Centigrade Pressure mmHg 1 102 20 17 5 1 096 21 18 7 1 091 22 19 8 1 085 23 21 1 1 080 24 22 4 1 075 25 23 8 1 068 26 25 2 1 063 27 26 7 1 057 28 28 3 1 051 29 30 0 2 Arm Span Factors for Participants with Severe Spinal Deformities Correction for Height Male Ht Arm Span 1 03 Black Males Ht Arm Span 1 06 Female Ht Arm Span 1 01 PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 76 12 2 3 Height 1 From inches to centimeters Multiply by 2 54 2 From centimeters to inches Divide by 2 54 12 2 4 Barometric Pressure 1 From inches of mercury to millimeters of mercury multiply by 25 4 12 2 5 Temperature 1 From Centigrade to Fahrenheit 9 5 X C 32 2 From Fahrenheit to Centigrade 5 9 X F 32 12 2 6 ATPS Ambient Temperature amp Pressure Saturated with Water 12 2 6 1 ATPS to STPD STPD PH20 PB PH20 760 X 273 273 T Water Vapor Pressure at Ambient Temperature C 12 2 6 2 ATPS to BTPS BTPS 273 37 273 T PB PH20 PB 47 T ambient temperature PB Atmospheric pressure mmHg Water Vapor Pressure see 12 3 1 12 2 7 ATPD Ambient Temperature amp Pressure Dry 12 2 7 1 ATPD to STPD PB 760 X 273 2734T 12 2 7 2 ATPD to BTPS PB PB 47 X 310 273 T 12 2 7 3 ATPD to ATPS PB PB PH20 12 2 8 BTPS Body Temperatu
18. must be known in order to run To load any of the programs below simply type in the three letter code as indicated when the Main Pulmonary menu is displayed 9 5 1 BRK Break the Pulmonary Program This command will interrupt the Pulmonary Program and put the operator into the IBM operating system as designated by the character C gt on the screen when BRK is typed When the character is displayed the operator has the following options Type GO and press ENTER to reload the spirometry software from hard disk drive C or Enter a command recognized by the IBM operating system MS DOS ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 58 9 5 2 STO Automatic Participant Data Storage This command will automatically store the participant data from the pulmonary program disk drive C to the data storage disk drive A without running the DIS program This will be helpful if a large number of participants are being screened in a short period of time It is not recommended for routine use as there is no confirmation that the participant was actually stored without checking the directory in the DIS program 9 5 3 CAL Check Calibration Type CAL or press the F4 function key to load the calibration check program This program will allow the operator to verify the calibration accuracy using a 3 liter syringe Note This program does not change or correct calibration It will merely assist the operator to determine wh
19. operator will make a second copy of that week s testing by downloading the hard disk to a second mailer floppy disk One floppy data mailer diskette will be mailed to the Pulmonary Function Reading Center every Friday and the other diskette will be archived at the field center The computer will identify a random 10 sample of the participants tested whose spirograms will be hand measured and sent to the Pulmonary Function Reading Center ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 4 2 PULMONARY EQUIPMENT 2 1 Description The Collins Survey II water seal spirometer is equipped with a device linear motion potentiometer which changes the mechanical motion of the spirometer bell into an electronic output The computer interprets this electronic signal as volume In the computer this volume signal is processed differentiated with a time signal by the A D interface to give a flow signal which is interpreted and stored The Collins Survey II Spirometer has been developed by and is available from the Warren E Collins Company The spirometer consists of two concentric metal cylinders 22 and 24 cms in diameter respectively Between these inner and outer cylinders is a water seal through which a bell may rise and fall The bell consists of a thin plastic cylinder with a domed top of light gauge aluminum A pen is attached to a plastic block projecting from the edge of the dome Vertical rods are mounted on t
20. performance Note Depending upon the participant s level of understanding a repeat demonstration may be required after each spirogram ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 34 8 5 Operation of the Flow Volume Loop Program l Change the mouthpiece Ze Load chart paper on the kymograph for the paper tracing 3 Type FVL or press the F2 key to load the program The screen will display the axes seen in Figure 9 4 Have the participant breathe normally through his mouth while wearing noseclips 5 Tell participant to Take as deep a breath in as you possibly can Ask the participant to raise his hand when he can t take in more air Press SPACE BAR as participant begins this inspiration SPACE BAR MUST BE PRESSED BEFORE PARTICIPANT INHALES FULLY TO TOTAL LUNG CAPACITY TLC at least one second before the participant begins to expire to allow the kymograph to get up to speed Coach the participant to Breathe deeper deeper deeper 6 Tell participant to put the mouthpiece in his mouth 7 At TLC tell the participant to Blow out as hard as fast and as long as possible until no more air can be expired Note Participant must be encouraged to blow as long as possible without re breathing The subject should be able to exhale for a minimum of six seconds and should continue exhaling until the the end of the test The technician should not tell the subject to Hold it since this may lead
21. stored on the hard disk to this second Mailer floppy disk After the copy is done notice that the number in parenthesis will be zero indicating that the files have been erased from the hard disk Note A NEWLY FORMATTED DISK MUST BE AVAILABLE FOR THIS PROCEDURE SEE SECTION 9 2 1 FOR FORMATTING DIRECTIONS IT IS ESPECIALLY IMPORTANT TO REFORMAT DISKS WHICH ARE BEING RECYCLED AND MAY CONTAIN OLD PULMONARY FUNCTION FILES OR OTHER TYPES OF FILES 9 4 5 Print Directory of Mailer Disk Press 7 Print a listing of the contents of the mailer disk by pressing 7 Verify that the listing from the mailer disk contains the same participants as the listing from the archive disk 9 4 6 Select Random 10Z Sample Select the spirograms from a 10 sample of participants tested this sample will include at least one tracing from each technician To select the tracings do the following a Press 9 to return to the Main Pulmonary menu b With the mailer disk for the week in drive A type BRK c The computer will leave the pulmonary program At the DOS prompt C type RANDOM ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 57 The computer will ask how many tests were NOT stored on the computer for the week Every participant should be eligible for selection If none enter 0 The printer will print the random listing of participant names and study numbers Obtain these tracings from the file and measure the three b
22. the volume number as described above At the end of each week two diskettes an archive and a mailer diskette must be formatted Reply Y to the prompt Format another insert another new disk into drive A and press Enter when prompted If no more disks are to be formatted reply N to the prompt Format another Enter volume number of field center Archive Disk and Pulmonary Reading Center Mailer Disk on Daily Spirometer Log Archive disks will be given an odd number mailer disks will receive an even number Type GO to Return to the Pulmonary Menu screen Data Storage Procedures Daily Insert the properly formatted and labelled diskette for the week in drive A before running any tests At the end of each test the current subject s tests are automatically written to a hard disk file and a backup floppy disk file At the end of a participant test attach labels containing ID number name date time quality code and temperature to the tracings ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 54 9 4 Data Storage Procedures Weekly 9 4 1 Operation of the Disk Storage Program 1 Type DIS or F6 from the main Pulmonary program menu to load the DISK STORAGE program a The Disk Storage DIS program will be run at the end of each week to record the data stored on the hard disk onto a second floppy disk for mailing to the Pulmonary Function Reading Center The Disk Storage Program Menu wil
23. 528 Rudolph one way valve with Stopcock Rudolph Cat 2150 Extra spirometry supplies which should be on hand are 1 2 3 4 Large disposable cardboard mouthpieces Dispenser of 90 mouthpieces Collins Cat 22401 Disposable noseclips A M Systems Cat NC 100 Disposable recording pens red Collins Cat 22411 Kymograph chart paper with adhesive strip 100 Sheets 9 x 19 5 8 Collins Cat 22037 2 participant breathing tubes 1 1 2 I D each consisting of l 34 plastic spiral tubing Collins Cat 022263 2 1 3 8 moulded tubing ends Collins Cat 022254 2 internal breathing tubes 1 1 8 I D each consisting of l 13 plastic spiral tubing Collins Cat 022261 2 1 3 8 moulded tubing ends Collins Cat 022253 Tubing cement Collins Cat 022977 Metal leak tester weight Collins Cat 021525 Mercury thermometer Collins Cat 22949 Stead Wells plastic spirometer bell Collins Cat 700322 Stopwatch Pliobond glue flexible contact cement for repairing leaks Other Supplies purchase locally Ko O0 4 OV UI P WN rS e e o Cidex Vinegar Silicon spray lubricant Rubber stoppers size 7 Alcohol wipes Q tips 6 inch Smelling Salts A power strip with grounded outlets circuit breaker pilot lights line voltage suppressor and master switch Allen wrench ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 A 96 Vendors and Te
24. 7 7 10 87 Prediction Equations FEMALE age equal to or greater than 20 Parameter FVG FEV FVC FEV 5 FEV FEV FEV FVC FEF200 1200 PF FEF252 FEF50Z FEF75Z FEF25 75 FEF75 85 Equation 0 0491H 0 0216A 3 590 0 0342H 0 0255A 0 37H 0 019H 0 027H 0 035H 0 11H 0 37H 0 049H 0 043H 0 035H 0 021H 0 06H Height expressed in centimeters ARIC PROTOCOL 4 0 022A 0 014A 0 021A 0 023A 0 109A 0 036A 0 025A 0 025A 0 013A 0 014A 0 244 0 021A 0 0 ig 1 578 1 774 406 794 633 107 38 2 0 0 532 735 132 444 042 171 321 Pulmonary Function Assessment Reference Crapo Crapo Knudson Knudson Knudson Knudson Knudson Morris Knudson Knudson Knudson Knudson Knudson Morris Version 1 7 7 10 87 A 94 A 95 Appendix V Equipment Supplies and Vendors Replacement Equipment and Supplies The maintenance and supply kit provided with the S amp M Pulmo Screen II system includes l 2 IL QC Ww 0 10v Ui PRU S amp M Pulmo Screen II Instruction Manual IBM PC manuals Guide to Operations BASIC Manual DOS Manual and Printer Manual Collins one year warranty Disposable mouthpieces Disposable noseclips Disposable recording pens Kymograph chart paper with adhesive strip Metal leak tester weight Collins Cat 021525 3 liter calibrated syringe Rudolph Cat 5
25. 96 FEV 3 FVC X 91 6 i FEV 6 1 5 44 FEV 3 FEV 6 3 91 FEF25 75 ls 4 83 2 i PEFR s 11 29 FEF25 UA 7 92 FEF s 2 1 23457 6 Of E ls 2 13 2 of 5 spirograms are reproducible Press ESC key to end Figure 10 FVL Screen at end of test showing two reproducible FVCs ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 36 F9 Color graphics display this key will overlay up to three loops in color on the screen This is the best display for comparing reproducibility of initial maximal effort Figure 11 F1 F3 Fl F2 and F3 may then be used to alternately remove and or add selected trials Fl presents the graphics overlay of best flow volume loop F2 the second best and F3 the third best tests as determined by the highest sum of FEV FVC American Thoracic Society ATS criteria F6 Use F6 or V to redraw flow volume loop with volume time axes and alternately use F6 or F to change the volume time spirogram back to flow volume loop display Figure 12 11 WHEN PARTICIPANT TESTING IS COMPLETED PRESS ESC At this point the technician is required to enter an overall quality code Figure 13 8 6 Quality Assessment Every Subject should perform five maneuvers to obtain three that are considered acceptable and two that are reproducible The criteria for acceptability and reproducibility are described below The accuracy of spirometric measurements depends on the quality of the spirog
26. ATHEROSCLEROSIS RISK IN COMMUNITIES STUDY Manual 4 Pulmonary Function Assessment The National Heart Lung and Blood Institute of the National Institutes of Health ARIC PROTOCOL Manual 4 Pulmonary Function Assessment For Copies Please Contact ARIC Coordinating Center Department of Biostatistics CB 8030 Suite 203 NCNB Plaza The University of North Carolina Chapel Hill NC 27514 Version 1 7 July 10 1987 ii FOREWORD This manual entitled Pulmonary Function Assessment is one of a series of protocols and manuals of operation for the Atherosclerosis Risk in Communities ARIC Study The complexity of the ARIC Study requires that a sizeable number of procedures be described thus this rather extensive set of materials has been organized into the set of manuals listed below Manual 1 provides the background organization and general objectives of the ARIC Study Manuals 2 and 3 describe the operation of the Cohort and Surveillance Components of the study Detailed Manuals of Operation for specific procedures including reading centers and central laboratories make up Manuals 4 through 11 Manual 12 on Quality Assurance and Quality Control contains a general description of the study s approach to quality assurance as well as specific protocols for each of the study procedures The version status of each manual is printed on the title sheet The first edition of each manual is Version 1 0 Subsequent modifications of Ver
27. ATpP T MOT 7 10 87 Pulmonary Function Testing Version 7 ARIC PROTOCOL 4 noz 85 ARIC Quality Control Report for Randomly Selected Spirograms in Washington County Maryland Date of Test 07 10 87 TECHNICIAN 031 PARTICIPANT W139088 PARTICIPANT NAME COMMENTS GOOD TESTS WITH MAXIMAL EFFORT WHEN THE BASELINE IS BELOW ZERO THE DISTANCE BELOW ZERO SHOULD BE ADDED TO YOUR MEASUREMENTS Comparison of Measured Results at Pitionaty Reading Center and Field Center PULMONARY CENTER FIELD CENTER DIFFERENCE FVC 3 35 3 35 0 00 OFEV 2 55 0 RS 1 18 5 moe Comparison of Measured Results to Computer Results MEASURED COMPUTER DIFFERENCE FVC 3 35 3 43 2 39 FEV 2 55 2 57 0 78 o Differences 3X4 are acceptable ARIC PROTOCOL 4 Pulmonary Function Testing Version 7 7 10 87 J JFI F UOTSTATP T A 86 0v TTG c v9 9 eE OF 46 Le vr9 0 6iv E 085S c 0274 BB ED BS LY SSS 0 00v E g9ev c 99 4 eb OD 6S ST 997 0 QWNTOA 9 O SMOTJ ead JTP x IAS vA3SS MOT 88d edors aud E erBuv TOA 88d JAS j T A34 f MOTJ Je d adO S 8dd e arbuv TOA 5eagd x JAS T3307 MOT 88d edors aug y erBuv TOA 5eag x 98806 TM 69SM HSVM 3 eee 998 T TuOTStAtp fF MOT J Pulmonary Function Testing Version 7 7 10 87 ARIC PROTOCOL 4 A 87 Weekly Report to Coordinating Center from Pulmonary Readin
28. COL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 11 5 PROTOCOL SUMMARY Participants in the ARIC study are to perform pulmonary function tests as part of the routine cohort clinical examination The following summary gives the operator an overview of the pulmonary testing and data management procedures Each area will be explained in subsequent chapters 5 1 Daily Procedures 5 1 1 Instrument Preparation and Calibration Power up the computer check water level and water temperature in the spirometer attach hose to the spirometer check pen on the kymograph load chart paper on the kymograph for the tracings insert the field center archive diskette for the week in drive A and run the calibration leak and linearity checks before the first participant arrives for testing Log the results of the calibration leak and linearity checks on the Daily Spirometer Log see page 15 which is to be initialled by the responsible technician 5 1 2 Participant Identification For each participant enter the following information into the computer 1 ID number 2 Name 3 Age 4 Height cm 5 Sex 6 Ethnic group 7 Temperature 5 1 3 Participant Spirometry Testing Perform pulmonary function tests on each participant Prior to testing explain the purpose of the test position the subject change the mouthpiece and place chart paper on the kymograph for the paper tracing Following the experience of Ferris et al 16 the
29. Coordinators FROM ARIC Coordinating Center DATE July 1 1988 SUBJECT Replacement pages for ARIC Manual 4 Version 1 8 a a a a ee a a a i a a ae For the above named manual please replace the entire manual or the title page and the page s listed on the Revision Log with the enclosed material The footer of each page in the manual is updated to reflect the date the Steering Committee approved the revision and the manual s new version number Please note that pages are usually printed front and back and you will often have to replace two pages even though only one page of text has been revised Remove the outdated pages in your current manual and file them for future reference The specific changes made to this new version are printed below in capital letters Page 18 Section 6 6 12 line 5 correction barber POLE declining spiral major leak Page 19 Section 6 7 immediately following 3 b addition NOTE The position of the BLACK collar has been calibrated at the factory to allow the delivery of a 3 liter volume when the silver collar is locked into place against it DO NOT ADJUST THE POSITION OF THE BLACK COLLAR Page 29 Section 7 1 10 line 2 correction Change by typing in the new SPIROMETER TEMPERATURE Page 64 Section 11 5 Column 58 60 Correction BLANKS Page 69 Section 11 5 Column 510 Correction then insertion Column Text 510 512 Pulmonary Technician Code 513 Status Code 009 man p
30. ESC for Pulmonary Menu Leakage is over 10 FVL Screen showing leakage over 10 FVC Figure 15 Version 1 7 7 10 87 Pulmonary Function Assessment ARIC PROTOCOL 4 Flow 4 division 4 1 sec p MCC CECE eee PCE BEBENENEENEENN PASSES ACRE tH Figure 16 Submaximal Effort Page 40 Volume 1 division 4 liter ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 41 Flow 4 diviston 1 1 sec Volume 4 division 4 liter VLE Oe 0 0 ie a ESETTESHI Figure 17 Obstruction of Mouthpiece ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 42 MM A i TIN INL COUGHING TURA DTPTREETETTTETTO Cough Figure 18 Version 1 7 7 10 87 Pulmonary Function Assessment ARIC PROTOCOL 4 Page 43 QIIIA all iil TALL LL EEEELELEEFELTT C No M LOW WATER LEVEL IN SPIROMETER 4 LITE RAP EERE TEUER Low Water Level Figure 19 Pulmonary Function Assessment Version 1 7 7 10 87 ARIC PROTOCOL 4 Page 44 ta abt Ele ll TEEEEEETPETHI 5 131 181 1 TIL A III EE II INL ALT my BM E t T ELELEEL H tl FEED UNSUSTAINED EFFORT Premature Termination No Plateau Figure 20 Version 1 7 7 10 87 Pulmonary Function Assessment ARIC PROTOCOL 4 Page 45 Name SMITH JOHN Date 01 29 1987 Study ARIC
31. T W139540 PARTICIPANT NAME COMMENTS BREATH HOLD LEAK gt 5 OF FVC BORDERLINE SUBMAXIMAL EFFORT SEE FVL GRAPH THE LOOPS DO NOT RISE SHARPLY TO A PEAK BUT THE FEVI S ARE REPRODUCIBLE IN YOUR COACHING amp DEMONSTRATIONS BE SURE TO EMPHASIZE THE IMPORTANCE OF THAT FIRST BLAST OF AIR THE PARTICIPANT BLOWS OUT BLASTING THE AIR OUT AS SOON AS SHE PUT THE MOUTHPIECE IN HER MOUTH MAY HAVE PREVENTED BOTH PROBLEMS LEAK amp SUBMAXIMAL FFORT Comparison of Measured Results at Pulmonary Reading Center and Field Center PULMONARY CENTER FIELD CENTER DIFFERENCE FVC 2 98 2 98 0 00 FEV 2 51 ra 0 00 Comparison of Measured Results to Computer Results MEASURED COMPUTER DIFFERENCE FVC 2 98 3 05 29 35 FEV 2 51 2 52 0 40 Differences lt 3 are acceptable ARIC PROTOCOL 4 Pulmonary Function Testing Version 7 7 10 87 J83 T T UOTSTATD T eunt oA A 84 L00 08 c 9E E BL E LL eL i 068 0 6TO E 68r c GE E ev c 68 88 GBE T v0 E 978 2 E v 2 ZEY OE EB 2003 ea SMorj xeed JTP x w agp sedors eJd stp x JAS T A33 MOIT 88d edo s add erBuy TOA 88g x IAS TAJd MOIJ ad edors augd g aTbuy TOA Jead JAS vAas MOT 88d edo sS add y aruy TOA 88d x OvVSGETM 2SSM HSVM 3 PT TTT ttt AN Ie PT TTT TT tT tT Tt LLL LLLL LLL ge LLLI LL LLLL LL NI ENENEHSSENESENSZM iss eee eee BEXENNNENENEZNNENE SERRE ES 288 T FeUOFST
32. THE PULMONARY FUNCTION READING CENTER TO THE FIELD CENTER AT WASHINGTON COUNTY MD Date 7 17 87 For the period 7 8 87 to 7 10 87 we have received 9 records on 1 disk 3 paper tracings from a sample of participants Our reading of the mailer disk has shown 6 acceptable participant records 67 Of the unacceptable records we found 1 Borderline submaximal effort FEVI s reproducible 1 Cough inhalation present 1 Breath hold leak and submaximal effort Of the acceptable tracings we agree with your assigned quality code in 6 participant records 1007 Of the acceptable tracings 6 were found to be reproducible 100 From 7 8 87 to 7 10 87 we have received 3 calibrations of times calibration within range Rate Time Check 29 7 30 3 3 100 Leak Check 10cc 30 sec 3 1007 Linearity Check 0 1 3 100 Volume Check Computer 2 91 3 09 L 3 100 Chart paper 2 91 3 09 L 3 100 ARIC PROTOCOL 4 Pulmonary Function Testing Version 7 7 10 87 Electronic Evaluation of Acceptability and Quality Field Center Acceptability codes ow m ouo wm wg w tt l 2 3 4 5 6 7 9 Reading center and field center quality Spirometer not calibrated correctly Computer started after start of expiration Breath hold leak gt 5 of FVC Submaximal effort rounded peak on FVL loop Cough inhalation present No plateau and tests not carried to 10 sec Low water level in spirometer Flow volume loop not stored codes
33. TS recommendations Amer Rev Respir Dis 123 659 664 1981 Morris JF Koski WA Johnson LC Spirometric standards for healthy non smoking adults Am Rev Resp Dis 1971 103 57 67 Bass H The flow volume loop normal standards and abnormalities in chronic obstructive disease Chest 1973 63 171 176 Boren HG Kory RC Syner JC The Veterans Administration Army cooperative study of pulmonary function II the lung volume and its subdivisions in normal men Am J Med 1966 41 96 114 Kory RC Callagan R Boren HG Syner JC The Veterans Administration Army Cooperative study of pulmonary function I clinical spirometry in normal men Am J Med 1961 30 243 258 Goldman HI Becklake MR Respiratory function tests normal value at median altitude and predictions of normal results Am Rev Resp Dis 1959 76 457 467 Lindall A Medina A Grismer TJ A re evaluation of normal pulmonary function measurements in adult females Am Rev Resp Dis 1967 95 1050 1064 Bates Macklem and Christie Respiratory Function in Disease WB Saunders Philadelphia 1971 Morris JF Koski WA Breese JW Normal values and evaluation of forced end expiratory flow Am Rev Resp Dis 1975 111 755 761 Morris JF Normal values for the ratio of one second forced expiratory volume to forced vital capacity Am Rev Resp Dis 1973 108 1000 1003 Knudson RJ Slatin RC Lebowitz MD Burrows B The maximal expiratory flow volume curve normal standards variability and effec
34. a forced expiration best seen on spirogram paper tracing a Premature termination plateau not achieved 6 See Figures 20 and 21 Note We recognize that the spirograms of a participant with airway obstruction may not be able to reach a plateau due to the participant s narrowed airways and not the technician s early termination of the test Spirograms which do not plateau should be continued for at least 10 seconds 8 6 1 3 Error Messages Displayed by Field Center Computer The following Error Messages identify violations of the spirogram acceptability criteria Error Acceptability Code 1 Error Zero flow not found 2 The technician pressed the space bar late after the participant started to blow out Stop the test and repeat the maneuver 2 Leakage is over 5 of FVC 3 Back extrapolation for time zero indicates that more than 5 of the vital capacity was expired prior to onset of forced expiratory flow Repeat the maneuver ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 39 TEEEEREEELEEEI E me Y s le E DLE ll E xd 7 E lt H amp fa amp E a OF EXPIRATION DUUM TNT a CERED minin i Leakage over 5 of FVC Figure 14 Name SMITH JOHN Date 01 29 1987 Study ARIC Flow L S FVC FEV FEV FEV FEV 3 FVC FEV 6 FEV 3 FEV 6 FEF25 75 10 8 6 4 2 5Vol 4 of FVC Press SPACE BAR for FVL or
35. age mmo 7 1 88 ccp ARTC MANUAL OF OPERATIONS REVISION LOG VOLUME 4 Pulmonary Function Assessment The columns in the Log provide documentation of each version change and its implementation date during the course of the study The Coordinating Center will update columns 1 5 with each distributed update or revision You are responsible for recording the date on which you update your manual in column 6 1 2 3 4 5 6 Description of Revisions RVN New New For Pages to Pages to Effective Revision Version Version Date Section be Removed be Inserted Date Date oe ee NaS Bs es ee aetna ARENE 6 01 88 009 man4rev 1log 7 1 88 ccp ARIC PROTOCOL Manual 4 Pulmonary Function Assessment For Copies Please Contact ARIC Coordinating Center Department of Biostatistics CB 8030 Suite 203 NCNB Plaza The University of North Carolina Chapel Hill NC 27514 Version 1 7 July 10 1987 Version 1 8 June 1 1988 10 11 12 Note Page 18 Start the kymograph at fast speed to record the bell position over two rotations 30 seconds Start the stopwatch when the pen crosses the vertical line Press ENTER Turn the stopwatch off as the pen crosses the line at the end of the second rotation The time for two rotations of the drum should be between 29 7 and 30 3 seconds Enter in Time Check the time recorded from the stopwatch for two rotations on the Daily Spirometer Log The computer will sh
36. aling 2 Explain to the participant that he is not to take in any additional breaths until the forced expiratory maneuver is finished 3 Be sure to tell the subject that you the technician will be forcefully coaching him through the maneuver so that he is not taken by surprise 8 2 Postponement of the Test Pulmonary function testing will only be postponed on the grounds of medical incapacity to perform the test Since spirometry is routinely conducted in the medical intensive care unit it is unlikely that a participant well enough to walk into the ARIC facility will be unable to perform this test Nevertheless should the question of medical incapacity arise request a decision from the ARIC physician at the field center ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 33 8 3 Positioning the Subject l Testing should be conducted in the standing position A chair should be positioned behind the subject for use between maneuvers Smelling salts should also be kept on hand for the rare event of fainting or dizziness Allow sufficient time between trials to avoid exhausting the participant 2 The spirometer hose should be adjusted to the participant s height so that he she stands erect with chin slightly elevated Tight clothing such as a tie or belt which might restrict the subject s maximal breathing efforts should be loosened Dentures if they are loose should be removed since they will prev
37. ard disk Save at Field Centers Participant spirometry report Labelled participant spirogram tracings Archive back up floppy disks Send to Coordinating Center Respiratory inventory record Send to Pulmonary Reading Center every Friday Mailer floppy disk files of pulmonary data Listing of mailer floppy disk directory Spirometer calibration log Listing of 10 random sample of participants Tracings from the random 10 sample send original retain copy for field center files ARIC PROTOCOL 4 Pulmonary FunctionAssessment Version 1 7 7 10 87 Page 72 ARIC Pulmonary Reading Center Pulmonary Function Procedures PULMONARY READING CENTER Calibration checks Within center calibration reproducibility within 2 5 Between center calibration standardization Acceptability and reproducibility checks of electronic tracings Evaluate quality and compare with technician s quality code Acceptability will be evaluated on the following criteria smooth continuous exhalation apparent maximal effort and without the following discredits coughing early termination of expiration forced expiration must continue for at least 6 seconds the end of the FVC maneuver is defined by a volume change that has decreased to less than 0 025 liters over 0 5 seconds a leak obstructed mouthpiece unsatisfactory start excessive variability between the three acceptable curves Hand measure paper tracings of randomly selected 10 sample management
38. as in the breathing tube If however the reading does go down then the leak is in the internal tube or in the spirometer bell d Reach underneath and inside the spirometer and disconnect the internal tube from the topmost internal port Raise the bell halfway and insert a 7 solid stopper into this topmost internal metal tube connector e Again place the weight on top of the spirometer bell and run the kymograph at the fast speed Wait for five minutes 20 rotations then observe the kymograph reading If the reading does not go down in this period then you know that the leak was in the internal tube If however the reading does go down then the leak is in the spirometer bell ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 8 6 01 88 Page 19 f To locate a leak in the spirometer bell remove the bell turn it upside down and fill it with about an inch of water Hold the bell upside down for a while and then roll it over onto the seam Side observing to see where water escapes B When you have located the leak you may make a temporary repair using a substance such as Pliobond which can be purchased at most hardware stores h Prepare and tie a label to the repaired bell which reads DATE OF REPAIR DO NOT USE BEFORE __ To compute the DO NOT USE BEFORE date add two full calendar days to the DATE OF REPAIR Remove label before putting repaired bell back into service i Replace the hoses or the bell
39. at the leak was in the internal tube If however the reading does go down then the leak is in the spirometer bell ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 19 To locate a leak in the spirometer bell remove the bell turn it upside down and fill it with about an inch of water Hold the bell upside down for a while and then roll it over onto the seam side observing to see where water escapes g When you have located the leak you may make a temporary repair using a substance such as Pliobond which can be purchased at most hardware stores h Prepare and tie a label to the repaired bell which reads DATE OF REPAIR DO NOT USE BEFORE __ To compute the DO NOT USE BEFORE date add two full calendar days to the DATE OF REPAIR Remove label before putting repaired bell back into service i Replace the hoses or the bell for 48 hours from the spare parts on hand to continue testing See caution below j Order new spare parts from the equipment list and use the temporarily repaired parts as spares until the new parts arrive Caution Observe all manufacturer s warnings and precautions for whatever flexible plastic cement you choose to use Make sure to let the adhesive substance dry for at least 48 hours after application since breathing in the fumes could be harmful 13 6 7 Press the SPACE BAR to go directly to the Linearity Check To return to the Pulmonary Program Menu pres
40. by comparing ID s from the listing with the pulmonary function diskette files Examine the Daily Spirometer Log sheets Compare volume number on Daiiy Spirometer Log with that of the mailer disk received If a problem is apparent a call to the field center will be made to resolve the situation Process the diskette files to check the quality of the forced expiration a The volume calibration constant recorded on the diskette will be compared with the standard calibration curve generated for each field center A within center calibration correction is calculated and applied to the volume axis of the digitized points Variability within 2 5Z is acceptable If more than a 2 5Z deviation is recorded the field center will be notified and the tracings for that day will be requested b The digitized flow volume curves encoded on the field center diskettes will be independently electronically remeasured as volume time curves and the results compared with the results recorded on the field center diskettes c The digitized volume time curves of the three best tests are electronically evaluated for acceptability and reproducibility criteria A reading center acceptability code and quality code will be added to each participant s record The following criteria are used in evaluating acceptability Spirometer not calibrated correctly if the calibration factor which is stored on each participant s computer record is not within a specified rang
41. ceptability Pulmonary Function Assessment Version 1 7 7 10 87 193 194 195 196 197 198 202 203 204 205 206 212 206 207 208 209 210 ARIC PROTOCOL 4 Pulmonary Function Assessment O maximal effort 1 submaximal effort 2 borderline maximal effort 9 no flow volume loop stored for calculation acceptability O no cough or inhalation 1 cough inhalation present 9 no flow volume loop stored for calculation acceptability 0 plateau 1 no plateau 2 borderline plateau 9 no flow volume loop stored for calculation acceptability O water level is adequate l low water level in spirometer 9 no flow volume loop stored for calculation acceptability Status Code Blanks Number of pulmonary function tests done Status Code of of of of Acceptability code detail for second best test 0000000 acceptable O spirometer calibrated lespirometer not calibrated correctly 9 no flow volume loop stored for calculation acceptability O good start lecomputer started after start of expiration 9 no flow volume loop stored for calculation acceptability 0 no breath hold leak 1 breath hold leak gt 5Z 9 no flow volume loop stored for calculation acceptability O maximal effort l submaximal effort 2 borderline maximal effort no flow volume loop stored for calculation acceptability O no cough or inhalation 1 cough inhalation present 9 no flow volume loop stored for calculation ac
42. ceptability of of of of of Page 66 Version 1 7 7 10 87 211 212 213 214 216 217 220 221 222 227 228 230 231 232 239 240 241 248 249 250 257 258 259 267 268 269 276 277 278 279 286 287 288 295 296 297 304 305 306 313 314 315 322 323 324 332 333 334 344 345 352 ARIC PROTOCOL 4 Page 67 O plateau l no plateau 2 borderline plateau 9 no flow volume loop stored for calculation of acceptability O water level is adequate 1zlow water level in spirometer 9 no flow volume loop stored for calculation of acceptability Status Code Blanks Spirometer Temperature Celsius Status Code Blanks Race O white black 2 American Indian Alaskan 3 Asian Pacific Islander Status Code FVC Predicted liters Status Code FEV 5 Predicted liters Status Code FEV Predicted liters Status Code FEV FVC Predicted liters Status Code FEV FEV Status Code Blank PEFR Predicted Status Code FEF 5 Predicted Status Code FEF 9 Predicted Status Code FEF 5 Predicted States Code FEF 55 75 Predicted Status Code File Name on Pulmonary Function Reading Center system Status Code Blanks FEV FVC Predicted Pulmonary Function Assessment Version 1 7 7 10 87 353 354 356 Status Code Blanks BTPS corrected volumes 357 364 365 366 373 374 375 382 383 384 391 392 393 400 401 402 409 410 411 418 419 420 427 428 429
43. chnical Advice Replacement equipment and supplies may be obtained from the companies listed below l Spirometer spirometry supplies Warren E Collins Inc 220 Wood Road Braintree MA 02184 Phone 1 800 225 5158 A M Systems Inc 917 134th Street Everett WA 98204 2 3 liter calibration syringe metal valves stopcock Hans Rudolph Inc 7200 Wyandotte Kansas City MO 64114 Phone 816 363 5522 The accuracy of each syringe will be verified by returning it to the manufacturer for measurement of its water displacement every year during the study or whenever any evidence of physical damage to the syringe is noticed 3 Pulmo Screen A D pulmonary interface software and spirometry supplies S amp M Instrument Company 202 Airport Blvd Doylestown PA 18901 Phone 215 345 9232 4 Pathophysiology epidemiology methods and procedures of pulmonary function measurement Dr Melvyn Tockman ARIC Pulmonary Function Data Management Michele Donithan The ARIC Pulmonary Function Reading Center Johns Hopkins School of Hygiene and Public Health Room 7517 615 N Wolfe Street Baltimore MD 21211 Phone 301 955 4587 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 VI 10 11 12 13 A 97 References Peto R Speizer FE Cochrane AL Moore F Fletcher CM Tinker CM Higgins ITT Gray RG Richards SM Gilliland J Norman Smith B The relevance in adults of air flow obstruction
44. ction Assessment Version 1 8 6 01 88 Page 69 506 Technician s Quality Code 1 5 l spirograms last at least 6 seconds tracings reproducible smooth with continuous transition of slope 2 spirograms last at least 6 seconds tracings reproducible but irregular 3 spirograms last less than 6 seconds tracings reproducible smooth with continuous transition of slope 4 spirograms last less than 6 seconds tracings reproducible but irregular 5 spirograms not reproducible 507 Status Code 508 Reading Center Quality Code computer generated l spirograms last at least 6 seconds tracings reproducible smooth with continuous transition of slope 2 spirograms last at least 6 seconds tracings reproducible but irregular spirograms last less than 6 seconds tracings reproducible smooth with continuous transition of slope 4 spirograms last less than 6 seconds tracings reproducible but irregular 5 spirograms not reproducible 9 unable to assess quality 509 Status Code 510 512 Pulmonary Technician Code 513 Status Code 11 6 The Coordinating Center will respond to the Pulmonary Function Center by doing the following l Acknowledge receipt of the diskette from the Pulmonary Function Reading Center with a pre printed postcard to which they will add a date and a count of the records received ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 8 6 01 88
45. ction Testing Version 7 7 10 87 Fatient Directery Ordered by Names Nene U ARIC PROTOCOL 4 ID Numbers 138737 Wi 38005 W138694 W137923 W137891 106354 Wi1e8as5o W1898559 W135178 Wi138071 W138o060 W138106 W138119 1379965 W137935 4138480 W138534 W138529 WIiSBS90 W138633 W138495 Pulmonary Function Testing Version 7 in Drive C A 79 07 02 87 06 29 87 Q7 029 87 06 29 87 96 29 87 06 29 87 O7 O1 B7 07 01 87 07 02 87 06 30 87 06 30 87 06 30 B7 06 30 87 96 29 87 06 29 87 O7 O1 87 07 01 87 07 01 87 57 09 87 07 02 87 07 01 87 7 10 87 Tracings to be read for the week ending 02 17 88 A 80 Please read the tracings from the 3 best tests for each of the participants who are listed below the week ending 02 17 88 Ur WN M this listing the daily spirometer log the mailer diskette the directory of the mailer diskette tracings for participants who are not on the comptuer Send the following to the Pulmonary Reading Center for Check that the tracings include ID name date age height sex race technician code and temperature 6 the measured tracings for the participants listed below Date of Test 02 01 1988 02 03 1988 02 03 1988 02 05 1988 ID M120624 M125136 M126785 M131993 Name PARTICIPANT NAME PARTICIPANT NAME PARTICIPANT NAME PARTICIPANT NAME Technician 001 067 036 019 A 81 WEEKLY PROGRESS REPORT FROM
46. d by pressing F9 Name SMITH JOHN W101234 Trial FVC FEV 1 Date 01 29 87 Prebronchodilator 1 5 43 4 70 8 Uo D 2 3 76 3 31 cO wN Re Oo WwW AN 123 45 6 7 8 9 10 11 12 13 1415 16 17 18 19 20 Press SPACE BAR to CONTINUE Figure 12 FVL Screen obtained by pressing F6 Volume time curve Johns Hopkins University Name SMITH JOHN Date 01 29 87 Study ARIC Enter Quality Code for test 1 Figure 13 FVL Screen for entering quality code ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 38 8 6 1 2 Common Location of Typical Errors at the Beginning Middle or End of Forced Expiration Each of these errors has a most common location either at the beginning middle or end of expiration Error Location Acceptability Code 1 BEGINNING of a forced expiration best seen on flow volume loop displayed on screen by pressing F9 after the 3rd and last trials a Leakage over 5 of FVC See Figures 14 and 15 3 b Submaximal effort lack of steep rise to peak 4 flow See Figure 16 c Obstruction of mouthpiece Often seen as 4 reproducible submaximal effort with flattened top of FVL loop See Figure 17 2 MIDDLE of a forced expiration best seen on spirogram paper tracing a Cough or removal of mouthpiece resulting in 5 interruption of the smooth forced expiration See Figure 18 b Low water level resulting in incomplete 7 spirometer excursion See Figure 19 3 END of
47. der is correct 4 ID NUMBER participant identification number 5 TECHNICIAN S CODE the last entered technician code will appear The technician code consists of a unique three digit numeric code assigned to each technician at the four field centers by the Coordinating Center To change type in the new code Delete an entry by pressing ENTER and typing in a new entry DO NOT USE DELETE OR BACKSPACE KEYS TO CHANGE AN ENTRY 6 AGE enter age in years 7 SEX enter M for male and F for female 8 HEIGHT enter participant s measured height in centimeters 9 ETHNIC GROUP enter the number for the appropriate group Non white predicted values are reduced by 127 10 TEMPERATURE 23 Centigrade or the last entered value will appear Change by typing in the new spirometer temperature DO NOT PRESS DELETE OR BACKSPACE Before leaving INF the technician should verify that the name and the I D number entered match those on the participant s folder 7 2 Editing Information If a mistake was made when entering the above information use the arrows on the right side of the keyboard cursor pad to move the cursor to the ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 8 6 01 88 Page 64 2 Electronic evaluation of acceptability and quality 3 Hand measured evaluation of randomly selected spirograms Specific corrections and recommendations are provided if the Pulmonary Function Reading Center disagrees with
48. e of values this condition is flagged The acceptable ranges are determined from the results of the annual standardization visit Computer started after start of expirations if the flow is greater than 10 liter second at the beginning of a flow volume loop this condition is flagged PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 63 Breath hold leak gt 5Z if the volume at the back extrapolated start of the test is greater than 5Z there is a leak Submaximal effort the two best tests are compared on several measures The angle formed at the peak of the flow volume loop the slope of the line from the origin to peak flow and the volume at peak flow are used for determining maximal effort Cough inhalation present if the volume drops 50cc or more from any previous volume before reaching FVC then a cough inhalation is detected No plateau if there is greater than 50cc change in volume in the last two seconds of the test then no plateau has been reached However if the participant continues his her exhalation for gt 10 seconds the tracing will be borderline acceptable even without a plateau d The between center calibration standardization factor will be applied to the reported volume values and the digitized volume time curve An initial between center calibration factor was determined by transporting the Pulmonary Function Reading Center syringe to each of the four field centers in Oc
49. end of testing generates a summary report and interpretation from the printer and automatically stores the subject s record to both hard disk and to back up floppy 4 2 4 CAL Calibration Check This program will verify the calibration of the system and decide if an adjustment ADJ needs to be run 4 2 5 ADJ Calibration Adjustment This program will adjust electronic volume and flow signals to the mechanical displacement from the 3 liter calibration syringe An actual calibration factor is stored on the program disk and is updated each time ADJ is run This program must be run each day before participant testing 4 2 6 DIS Disk Storage This program will allow the operator to conduct the weekly data storage procedures including display and printing of participant directories and transfer of data from hard disk to floppy mailer disk 4 2 7 LIN Linearity Check This program checks to be certain that the injection of one liter of air causes the same volume change in the spirometer both at low and at high volumes When operated at high volumes this program also checks the spirometer water level This check is made daily before participant testing A calibrating syringe and a Rudolph l way valve are required 4 2 8 LEA Spirometer Leakage Check This program prompts the technician through the steps necessary to find air leaks in the system This check is made daily before participant testing A weight is required ARIC PROTO
50. ent a tight seal from being formed around the mouthpiece If they are not loose they should be left in place 3 In order to prevent nasal leakage at full inspiration or nasal inhalation at the end of the forced expiration a noseclip will be used during the maneuver While wearing noseclips the subject should avoid swallowing which blocks the ears and is very uncomfortable Note Disposable noseclips have been more generally accepted by participants However disposable noseclips occasionally slip off certain individuals who therefore require reusable clips 8 4 Demonstration of Procedure 1 With an extra mouthpiece demonstrate that the teeth and lips should go around the mouthpiece The lips should not be pursed like a trumpet player s and the tongue should not block the mouthpiece during the expiration 2 Demonstration by the technician of the completeness of the inspira tion and of the forcefulness completeness and smoothness of the expiration is required for each participant Such a demonstration may prevent time and effort from being wasted on unacceptable forced expiratory efforts which are caused by the subject s failure to understand a verbal explanation of the procedure Note A fainthearted demonstration often results in a submaximal participant performance 3 If after an initial demonstration the participant fails to produce an acceptable spirogram the technician should demonstrate both the error and the correct
51. er than or equal to 61 5 Moderate obstruction the ratio of FEV to FVC is less than 60 and greater than or equal to 452 6 Severe obstruction the ratio of FEV to FVC is less than 452 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 50 Johns Hopkins University ARIC Spirometry Study Patient SMITH JOHN Age 56 B P 760 ID Number W101234 Height 63 in 160 cm ATPS 931 Date 01 29 1987 Time 09 40 Sex M Temp 25 Technician 032 Last Calibration 01 29 87 Time 08 15 Ethnic Group White BTPS Spirometry Actual Pred Pred FVC L 3 77 91 4 14 FEV 1 L 2 88 82 3 51 FEV 3 L 3 74 93 4 02 FEV 6 L 3 77 91 4 14 FEV 1 FVC 77 84 FEV3 FEV6 99 Total Trials 5 Quality Code 1 Comments Computer Impression Spirometry The Ratio FEV 1 FVC is 77 suggesting Mild OBSTRUCTION Short expiratory time may hide mild Obstruction Note Computer Impression is subject to Physicians review and confirmation Physician Figure 22 DAT Spirometry Report ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 51 If the FEV falls between 66 and 80 of predicted the report will identify the type of impairment and note that the value falls into the borderline low range but will not recommend further evaluation If the FEV falls below 66 of predicted the report will identify type of impairment obstruction or restriction and recommend that the
52. est curves curves with best FEV s and best FVC s on each tracing Record the FEV and FVC measurements raw and corrected to BTPS on the tracing Make a photecepy of the tracing for the participant s file To return to the pulmonary program type GO 9 4 7 Prepare Mailing to the Pulmonary Reading Center Mail the following items to the Pulmonary Reading Center on Friday for that week s testing The mailer floppy disk A listing of the contents of the mailer floppy disk A copy of the daily spirometer log for the week The listing of the 10Z random sample of participants for the week A 10 sample of tracings for the week The best three curves from each of these tracings must be measured Ui PB WN Ee 9 4 8 Prepare Diskettes for Next Week s Testing Format and label two floppy disks for the next week The format procedure is described on page 51 Each week two floppy disks will be used for storing pulmonary function test results One will be stored at the field center and the other will be mailed to the Pulmonary Function Reading Center The disks will be stored at the field centers for ten weeks and then the oldest may be recycled Recycled disks must be reformatted before being reused 9 5 Additional Menu Commands In addition to the MENU commands which are visible on the screen INF FVL DIS etc there are other commands which are not used as often but are nevertheless useful These commands are invisible however and
53. ether the ADJ program needs to be run again The calibration should agree with syringe volume within 3 or 90 ml whichever is greater Flow should read 0 00 liter second 90 ml sec The screen will display the following when the CAL program is loaded Volume Liters Flow Liters Second The date of the last calibration adjustment ADJ will be displayed or if not previously adjusted the following will appear Last Calibration was N A This statement indicates that the system is not adjusted ADJ must be run before any more participants are tested To run ADJ directly from the CAL program press the SHIFT and keys 9 5 4 Printing a Screen Any screen with graphics or data may be printed while it is displayed by pressing the Prt Sc key Individual data and graphics should be printed when they are displayed as not all information is transferred to the final report ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 59 10 CLEANING AND MAINTENANCE OF THE SPIROMETER 10 1 Emptying the Spirometer The spirometer is equipped with a petcock drain for convenience in emptying water from the spirometer body Locate the drain at the bottom rear of the spirometer body The top part of the drain consists of a lever which controls the valve through which the water flows The bottom part consists of a nozzle When this lever is at a right angle to the nozzle the valve is closed and water will not empty from the spirometer
54. f the Testing Day At the end of the testing day store the archive floppy disk turn off the computer and detach and clean the spirometer hose Enter a check in the box on the Spirometer Daily Log sheet to indicate that the hose has been cleaned 8 6 7 Definitions of Flow Volume Loop Parameters all Volumes Corrected to BTPS i The Flow Volume Loop Parameters examined by this program include 1 FVC Forced Vital Capacity expiratory is the volume of air forcefully expired following a maximum inspiration The accuracy of the FVC depends on whether the subject s inspiration is maximal and whether his expiration is complete 2 FEV Volume of air forcefully expired in one second from maximum inspiration Its accuracy depends upon whether the subject expels his air as fast as he can with a maximal effort 3 FEV FVC Ratio of volume of air forcefully expired in the first second to the total forced expiratory vital capacity expressed as a percent 4 FEV Volume of air forcefully expired in three seconds from maximum inspiration 5 FEV FVC Ratio of FEV to FVC expressed as a percent 6 FEF 25 75 Mean rate of flow expiratory measured between 25 and 75 of the forced expiratory vital capacity ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 48 7 PEFR Peak expiratory flow rate the topmost point of the flow volume loop 8 FEF25 FEF50 FEF75 Maximum expiratory flow rate measured at a
55. for 48 hours from the spare parts on hand to continue testing See caution below j Order new spare parts from the equipment list and use the temporarily repaired parts as spares until the new parts arrive Caution Observe all manufacturer s warnings and precautions for whatever flexible plastic cement you choose to use Make sure to let the adhesive substance dry for at least 48 hours after application since breathing in the fumes could be harmful 13 Press the SPACE BAR to go directly to the Linearity Check To return to the Pulmonary Program Menu press ESC 6 7 Linearity Check l Having pressed the SPACE BAR after successfully completing the Time and Leak checks the screen in Figure 3a should now appear on the display If you are entering the Linearity Check program from the Pulmonary Program Menu type LIN or press F7 2 The 3 liter calibration syringe the Rudolph 2150 stopcock and tubing normally stored next to the spirometer will be used at this time Flush the 3 liter syringe back and forth with room air several times then flush the spirometer twice with room air and stop at zero volume This ensures that the syringe and spirometer contain air at the same temperature 3 Set the 3 liter syringe to the l liter position by a Opening the syringe past the l liter mark Figure 4a b Using the Allen wrench to loosen the moveable SILVER locking collar and move it to the l liter mark Figures 4b and 4c Note The po
56. from the kymograph chart paper in Volume Check of the Daily Spirometer Log 11 Verify correct volume calibration by injecting full syringe volume Note as to whether the volume increases by the syringe volume i e 3 00 liters 3 or 90 ml as in Figure 7b Note If the volume calibration is not acceptable press the plus key and repeat steps 6 11 12 Advance the kymograph drum slightly by moving the SPEED control to FAST and then re centering the SPEED control 13 Enter the Add 3 liters volume displayed on the screen and the volume from the kymograph chart paper in Volume Check of the Daily Spirometer Log Note The difference between the beginning volume and volume after adding 3 liters must be within 3 2 91 3 09 liters on both the screen and the chart paper If the chart reading is off recheck your measurements 14 Disconnect spirometer hose from the Rudolph valve and allow the spirometer bell to fall to a resting position Flow should read 0 00 t50 ml sec when spirometer is still 15 Enter the Baseline volume displayed on the screen and the volume from the kymograph chart paper in Volume Check of the Daily Spirometer Log Note Possible reasons for the volume calibration check to fail are a Failure to completely fill and or discharge the syringe into the spirometer b Differences in the air temperature in the the spirometer and in the syringe Reflush and repeat the check c Air leak in the calibra
57. g Center Batch number Record in batch l 2 o 0 N A MM A w 11 12 13 14 15 16 17 19 20 21 22 23 Date ARP20015 DAT 07 14 1987 File name E E E F380 DAT m m oe mMm m m m m m m m mM mm mi m mMm m F377 DAT F378 DAT F379 DAT F381 DAT F382 DAT F383 DAT F384 DAT F385 DAT F386 DAT F387 DAT F388 DAT F389 DAT F390 DAT F391 DAT F392 DAT F393 DAT F394 DAT F395 DAT F396 DAT F397 DAT E E ARIC PROTOCOL 4 F398 DAT F399 DAT Participant ID F134774 F131779 F132688 F134668 F134138 F134707 F132739 F132795 F132724 F134341 F132692 F131918 F132518 F134569 F134602 F134550 F134763 F122237 F135051 F134095 F134982 F133126 F131926 Date of test 06 22 87 06 22 87 06 22 87 06 22 87 06 22 87 06 22 87 06 23 87 06 23 87 06 23 87 06 23 87 06 23 87 06 24 87 06 24 87 06 24 87 06 24 87 06 24 87 06 30 87 06 30 87 06 30 87 06 30 87 06 30 87 07 01 87 07 01 87 PF Sequence number 002221 002222 002223 002224 002225 002226 002227 002228 002229 002230 002231 002232 002233 002234 002235 002236 002237 002238 002239 002240 002241 002242 002243 Pulmonary Function Testing Version 7 7 10 87 Appendix II Troubleshooting A 88 Unsuccessful spirometry may be due to operator or equipment malfunction This troubleshooting guide is to help direct the operator to where the problem may be I
58. he outside metal cylinder to serve as guides for the bell preventing rotation as it rises and falls The potentiometer is mounted on one of these guide rods The total weight of the bell is 175 grams The bell is 23 cm in diameter and approximately 26 cm high allowing a working volume of at least 8 liters A large rubber tube is connected to an inlet at the bottom allowing access of expired air to the interior of the bell Increased pressure inside the bell causes an upward displacement A corresponding tracing is drawn on a kymograph which rotates at a fixed speed dependent upon the 60 cycle frequency of wall current This instrument was uniquely designed to measure breathing at great velocities and accelerations of air flow It has been shown that at the frequency of a typical forced expiration 4 cps the frequency response of this Stead Wells type of spirometer is nearly flat and that breathing maneu vers of this type would be recorded with a high degree of accuracy 15 Supplies needed for conducting spirometry include disposable mouthpieces disposable noseclips disposable red recording pens calibrated chart paper a calibrated 3 liter syringe a Rudolph one way valve stopcock connecting tubing a thermometer a metal leak tester weight and a stopwatch Computer supplies should include very high grade double sided double density diskettes TDK Brown IBM Verbatim or Dysan brands are recommended and fan fold perforated printer pa
59. he plastic bell 6 Wash the inside and outside of the spirometer bell with vinegar and rinse it with water Vinegar will remove the film that tends to build up on the bell ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 60 7 If contamination is believed to have occurred drain the water from the spirometer as directed at the beginning of this section Then plug the breathing tube connector with a rubber stopper and fill the internal pipe with a dilute disinfectant solution Cidex Alternatively the internal pipe can be removed by reaching up under the spirometer and detaching the tube ends from the metal collars at the top and front of the spirometer 8 When you have reached the time set for disinfection to have occurred remove the solution from the spirometer by unstopping the breathing tube connector and allowing the solution to pour out from the internal pipe After this has been accomplished rinse the pipe thoroughly 9 Replace the bell by inserting it over the guides and the potentiometer slide rod in the same manner in which you removed it Insert and retighten the pen holder screw the plastic stop and the potentio meter adjusting screw Be sure to not secure the adjusting screw too tightly as this may cause the potentiometer rod to break Simply turn the screw until it is firmly in place thumbnail tight is sufficient 10 When ready to operate the spirometer again fill it with water and at
60. ings from a random 10 sample of the participants The three best curves from these tracings must be measured 6 Format and label two floppy disks for the next week The format procedure is described on page 51 Each week two floppy disks will be used for storing pulmonary function test results One will be stored at the field center and the other will be mailed to the Pulmonary Reading Center 7 Empty and clean the spirometer bell Clean the internal spirometer hose 5 3 Manual Back up Procedures for Recording of Raw Pulmonary Function Data In the event that the computer or the computer programs do not function properly pulmonary function testing will be done manually The steps to be followed are 1 Label the chart paper with the pulmonary function labels containing subject ID number name and date 2 Also record on the chart paper the participant s age height sex ethnic group and spirometer temperature 3 Explain the purpose of the test and position the participant Mount the chart paper on the spirometer drum and start the rotation of the drum at the fast speed 4 Coach the participant through both maximal inspiration and smooth continuous forced expiration Place an identifying number near the tracing of each trial 5 Examine the trials as they are performed Testing should continue for five trials attempting to record at least two out of three acceptable trials with FVC values that are within 5 of each othe
61. ion for each ARIC subject will be entered from the computer keyboard in response to prompts from the participant information program INF INF is accessed from the MENU by typing INF or pressing Fl Enter the information requested on each line ending each entry with ENTER key Every item MUST BE ENTERED in order to calculate predicted values accurately See Figure 8 1l DATE will be read from the computer s internal clock 2 TIME will be read from the computer s internal clock 3 NAME a minimum of three letters must be typed in last and then first name with a maximum of 23 characters USE THE SPACE BAR TO SEPARATE LAST NAME FROM FIRST NAME Do NOT use a comma The technician should verify with the participant that the name listed on the participant s folder is correct 4 ID NUMBER participant identification number 5 TECHNICIAN S CODE the last entered technician code will appear The technician code consists of a unique three digit numeric code assigned to each technician at the four field centers by the Coordinating Center To change type in the new code Delete an entry by pressing ENTER and typing in a new entry DO NOT USE DELETE OR BACKSPACE KEYS TO CHANGE AN ENTRY 6 AGE enter age in years 75 SEX enter M for male and F for female 8 HEIGHT enter participant s measured height in centimeters 9 ETHNIC GROUP enter the number for the appropriate group Non white predicted values are reduced by 122
62. l appear Note During steps 7 through 9 highlighted count and volume numbers are not yet entered and indicate that the operator must press the SPACE BAR If errors are made pressing the minus sign will return you to the previous step 11 Enter Slope and Linearity from the screen into the Linearity Check of the Daily Spirometer Log Note Acceptable linearity will be less than 0 100 If a linearity is greater than this check spirometer bell or guide rods for damage If a linearity problem persists print a copy of the linearity screen and call the Pulmonary Function Reading Center 12 Press SPACE BAR to go directly to the Flow and Volume Calibration Checks To return to the Pulmonary Program Menu press ESC 6 8 Volume Calibration Check 1 Having pressed the SPACE BAR after successfully completing the Linearity check the screen in Figure 5a should now appear on the display If you are entering the Volume Calibration Adjust program from the Pulmonary Program Menu type ADJ or press F5 for the Flow and Volume Calibration Checks This program will calibrate the spirometer to the 3 liter syringe and determine the calibration factor which is then stored on the program disk Note ADJ must be run daily before any participants are tested or any time the system is re booted 2 Return the 3 liter syringe to the 3 liter position by a Opening the syringe fully Figure 3a b Using the Allen wrench to loosen the
63. l be displayed as in Figure 23 b The Name ID and Date of the participant currently on drive C Pulmonary Program disk is displayed at the bottom of the Disk Storage menu Note Participant data is stored both alphabetically and numerically There is no way to differentiate between first and last names therefore it is advisable that when entering Name in the Participant Information program INF the last name be entered first To differentiate between participants with the same name the number and the date of the test are used 2 Press 1 to display on the screen the directory of participants on the data storage disk a The Participant Directory can be displayed by participant name or ID and Date The menu shows the current order of the directory in parentheses after item number 4 To switch from one to the other and back press the key at the far right side of the keyboard or press 4 b Mode selected in storage can be changed at any time by the or 4 key c Select ID mode prior to printing directory 9 4 2 Print the Directory of the Hard Disk Press 2 Press 2 to print the directory of participants stored on the hard disk ranked by ID and Date The prompt will be Prepare Printer then press SPACE BAR Prepare printer as required and press the SPACE BAR The printer will produce the following directory ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 55 Disc Sto
64. loppy disk Verify that these lists contain the same participants 2 Copy download the test results for the week from the hard disk to a second mailer floppy disk which will be mailed to the Pulmonary Reading Center The downloaded copy will be automatically verified and then the hard disk will be erased when this procedure is successfully completed Note If more than 30 participants are tested in a week the download should be done after the 30th participant Failure to do this may result in data being lost when the floppy disk is full 3 Print a listing of the contents of the mailer disk and verify that this list contains the same participants as the archive disk 4 The computer will select the spirograms from a 10Z random sample of the participants tested The technician will measure the tracings of the three best trials Record the FEV and FVC measurements raw and corrected to body conditions BTPS o the tracing See Section 12 1 Make a photocopy of the tracing for the participant s file 5 Mail the following items to the Pulmonary Reading Center on Friday for that week s testing a The mailer floppy disk b A listing of the contents of the mailer disk c The daily spirometer log for the week a copy should be kept at the field center ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 13 d The listing of the 10 random sample of the participants for the week e The actual trac
65. moveable SILVER locking collar and return it to the 3 liter mark Figures 3b and 3c 3 Lower the spirometer bell to approximately 3 liters by loosening the breathing tube at its attachment to the Rudolph valve and releasing air from the spirometer 4 Figure 5a should be on the screen Press SPACE BAR 5 Figure 5b will appear on the screen Press SPACE BAR ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 24 Spirometry Calibration Adjustment Raise bell to at least 3 liters and connect to an open 3 liter syringe Figure 5a Volume Calibration Check Screen 1 Press SPACE BAR then pump syringe 3 times Figure 5b Volume Calibration Check Screen 2 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 25 6 Pump the syringe in and out at least three 3 times Take care not to bang the syringe at the end of travel to avoid flow artifact during calibration Figure 6a will appear on screen After completing the third cycle press the SPACE BAR Note One injection and withdrawal constitutes one cycle 7 If the calibration was correctly done Figure 6b will appear on the screen Press SPACE BAR to continue 8 Leave the syringe connected to the spirometer The screen will show Figure 7a 9 Advance the kymograph drum slightly by moving the SPEED control to FAST and then re centering the SPEED control 10 Ent r the volume displayed on the screen and the volume
66. n 6 4 Section 6 5 Section 6 6 Section 6 6 Section 6 7 Section 6 8 Section 7 2 Sections 8 1 8 6 pages 38 45 Section 11 4 Version 1 7 7 10 87 Appendix III Configuration CON Set up Routine New S amp M program disks should be reviewed for proper configuration This should be done only when the system is first being set up When the MENU is displayed type CON to access the Configuration MENU The following will be displayed on the screen SYSTEM CONFIGURED FOR Volume Output only Auto Scale FVL On Information Enter Race Color Expired Only Normal INF Participant Data Storage on Drive C Printer IBM or Oki 92 Plug n Play 12 Inspired to Expired Loop must be 80 Z 13 No graph on Data Sheet 14 A D Address is 640 Dec 18 Extrapolate FEF 25 75 9000 U1 PF GO B2 S ENTER TO CHANGE ENTER TO END In the following the default selections are indicated by 1 SPIROMETERS 1 Med Science flow and volume output 2 Morgan with Diff 3 Ohio with Diff Ohio 840 842 with Diff 4 Volume Output Only Ohio 827 Collins Survey Stead Wells Jones Breon 5 Jaeger Pneumotach 6 Vitalograph ENTERED DESIRED OPTION PRESS ENTER ENTER key only will select the default option 2 AUTO SCALE FVL On 1l Auto Scale FVL Off 2 Auto Scale FVL On With Auto Scale ON the flow volume loop will be drawn with a smaller volume axis 3 INFORMATION Enter Race 1 No Race
67. n any case it is not designed to serve as a repair guide Any problems of a serious nature should be directed to S amp Instruments or the Pulmonary Function Reading Center as soon as possible The first rule of troubleshooting is There are three things to check before calling for service CONNECTIONS CONNECTIONS and CONNECTIONS A Troubleshooting Guide Hardware Problem Cause Solution When computer is turned 1 Power cable not connected on no display on video to monitor and or CPU monitor disk drive 2 No power to IBM light off 3 No power to monitor green light off 4 Wall outlet power off When computer is turned 1 Monitor not turned on no on no display on video power to monitor monitor disk drive light 2 Video cable not properly comes on attached to graphics board 3 Bad graphics board or loose fit in CPU Re insert or repair color graphics 4 No power to CPU unit only 5 Check brightness control Keys pressed on keyboard 1 Keyboard not properly connected are ignored after program or in need of repair is loaded Printer fails to print 1 Execute printer command when command is given 2 Check that printer is on line Funny characters printed If not re boot with CTRL instead of graphic or data ALT and DEL keys after turning display printer on Must be on before turning on IBM 3 Blown fuse on printer 4 Cable from printer to printer card not connected 5 Failure of internal board on printer 6
68. nds BRK press ENTER Leaves Pulmonary Program FORMAT A V press ENTER The screen will respond with the following Insert new diskette in drive A and strike any key when ready 9 2 2 Insert a new or blank disk in drive A and press any key Note Be certain that the disk in drive A is new blank or can be overwritten Once the format procedure has begun the information on the disk is permanently erased l The floppy disks will be labelled with the batch volume number ARabnnnn where AR is the two character study code for ARIC a is a one character ARIC agency code for the sending agency b is a one character ARIC agency code for the receiving agency nnnn is a sequential batch number counting all batches shipped from a to b since the beginning of the project ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Note Page 53 ARIC Agency Codes CODE SENDING AGENCY Field Centers F Forsyth County NC J Jackson MS M Minneapolis Suburbs MN W Washington County MD CODE RECEIVING AGENCY P Pulmonary Function Reading Center A paper label should be attached to the floppy disk This label should include the volume number described above and the date Be certain to label disks properly so as not to erase disks that contain stored participant data 3 9 2 3 9 3 1 25 When the format is complete there will be a prompt for entering a volume number for the diskette Enter
69. of Record Creation HH MM 24 hour clock 58 60 Pulmonary technician code ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 61 68 69 73 74 75 77 78 83 84 98 99 138 139 140 141 142 156 157 161 162 163 164 165 166 171 172 176 177 178 182 183 184 188 189 190 196 190 191 192 ARIC PROTOCOL 4 Page 65 Date of update MM DD YY Time of update HH MM Transaction type A Add a new record Change the record Delete the record Add the record because key fields were changed Erase the record because change was made to key fields AAO Volume ID and Workstation ID 00A Sequence number A six digit numeric field incremented each time a record is formatted for transmission to the Coordinating Center Blanks Participant Name last first initial Status Code Sex M F Status Code Blanks Height inches Status Code Age years Status Code Blanks Volume Calibration Status Code Flow Offset Status Code Flow Calibration Status Code Acceptability code detail for best test 0000000 acceptable O spirometer calibrated l spirometer not calibrated correctly 9 no flow volume loop stored for calculation of acceptability O good start 1 computer started after start of expiration no flow volume loop stored for calculation of acceptability 0 no breath hold leak l breath hold leak gt 5 9 no flow volume loop stored for calculation of ac
70. ograms Specific corrections and recommendations are provided if the Pulmonary Function Reading Center disagrees with the hand measured results from the field center see Appendix I 4 Flow volume plot of randomly selected spirograms B Weekly Report to Coordinating Center from Pulmonary Function Reading Center 1 Listing of participants whose processed records were included on floppy disk 2 Copy of field center report as noted above except 2 7 Based upon race and sex specific regressions generated from healthy non smoker pulmonary function measurements a Statistical quality control will be performed on the grouped data of each field center b Normal pulmonary function regressions will be calculated for each field center 11 5 File Format for Pulmonary Function Test Records The files will then be reformatted into fixed length ASCII records with the following format Columns Contents 1 7 Participant ID 8 12 Blanks 13 15 Form Code PFT 16 Version A 17 Record Type D 18 19 ARIC Study Code 30 20 21 Record type numeric code 13 22 Record type version number 0 A 0 B 1 etc 23 24 Contact Year 25 42 Blanks 43 44 Update level A two digit numeric field which identi fies which revision of the record this is Every record begins as update level 00 when created Each time changes are made to a record the update level is incremented by 1 45 52 Date of Record Creation MM DD YY 53 57 Time
71. ollins Spirometer 6 2 Water Level Temperature The spirometer water level should be visible through the water level gauge window Note If the level is not visible water must be added Also if the computer detects more than a 10 difference in linearity between the seventh and eighth liters the operator will be prompted to add water Before adding water disconnect the power cord Raise the bell several inches and pour water from the pitcher against the side of the bell to prevent spillage Ordinary tap water is usually quite satisfactory but if the water in your area is hard distilled water is preferable Enter Water Level check on Daily Spirometer Log Enter if additional water is required Enter the spirometer temperature on Daily Spirometer Log 6 3 Spirometer Hose dry clean spirometer hose should be attached to the spirometer each morning Attach the hose firmly to avoid leaks ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 15 DAILY SPIROMETER LOG Instructions Complete this form every day Keep this form in your spirometry notebook and send a good photocopy to the Pulmonary Reading Center and to the Coordinating Center weekly aily Checks Date Technician Code Water Level Temperature Pen Line width intensity Check if acceptable star if pen replaced Baseline Check if acceptable star if correction needed Time Check Seconds pe
72. or leakage test def 5 min Figure 2a Time and Leakage Check Spirometer Leakage Test Initial Volume 7 66 Liters Current Volume 7 60 Liters T me 0 30 Minutes Total Leakage 6 cc Leakage Rate 13 cc min Press SPACE BAR to Return to Menu Figure 2b End of Leakage Check ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 18 6 Start the kymograph at fast speed to record the bell position over two rotations 30 seconds 7 Start the stopwatch when the pen crosses the vertical line 8 Press ENTER 9 Turn the stopwatch off as the pen crosses the line at the end of the second rotation 10 The time for two rotations of the drum should be between 29 7 and 30 3 seconds Enter in Time Check the time recorded from the stopwatch for two rotations on the Daily Spirometer Log 11 The computer will show the display in Figure 2b 12 If there are no leaks in the system the kymograph tracing should remain horizontal and total leakage should be 10 cc or less A leak may be recognized on the kymograph tracing by the appearance of progressive thickening of the horizontal pen line small leak or a barber poole declining spiral major leak Enter in Leak Check the fall in volume in ml recorded from the screen over two rotations on the Daily Spirometer Log Note If time check falls outside acceptable range check connection to power source and check that the chart paper
73. ort generation Weekly Transmittal to FC Data receipt confirmation Quality control feedback Weekly Transmittal to CC Floppy disk of processed pulmonary data Copy of field center quality control feedback COORDINATING CENTER Data management Report Transmittal to PRC Data receipt confirmation Age sex standing amp sitting height weight and selected smoking and respiratory questionnaire responses Transmittal to FC Data receipt confirm Return of floppy disk ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Rage 71 ARIC Field Center Pulmonary Function Procedures FIELD CENTER Subject Enrollment Participant identifying data Generate 2 labels for spirometry tracings Respiratory and smoking questionnaire Anthropometry Measure standing height without shoes Measure sitting height Measure weight Spirometer Preparation and Calibration Mechanical and electronic preparation of instrument Daily log of calibrations maintained by technicians Participant Identification Participant Spirometry Testing Data Participant instruction Attach identifying label to paper tracing Spirometry testing Real time monitoring of quality by computer software Technician quality evaluation Management Raw pulmonary records are stored on hard disk and on archive floppy disk for the week Files downloaded from hard disk to second mailer floppy weekly and then erased from h
74. ow the display in Figure 2b If there are no leaks in the system the kymograph tracing should remain horizontal and total leakage should be 10 cc or less A leak may be recognized on the kymograph tracing by the appearance of progressive thickening of the horizontal pen line small leak or a barber pole declining spiral major leak Enter in Leak Check the fall in volume in ml recorded from the screen over two rotations on the Daily Spirometer Log If time check falls outside acceptable range check connection to power source and check that the chart paper is not slipping on the kymograph drum or that the kymograph drum is not slipping on its support Repeat test twice If still unacceptable call the W E Collins Co for repair Notify the Pulmonary Function Reading Center and mark tracings that Time axis incorrect Note If any leak is detected the operator will determine whether the leak is in the breathing tube the internal tube or in the spirometer bell a Disconnect the breathing tube from the spirometer b Raise the bell halfway and insert a 7 solid stopper into the metal breathing tube connector at the front of the spirometer Observe the reading on the kymograph drum where the recording pen touches the paper c Place the weight on top of the spirometer bell wait for five minutes 20 rotations then observe the kymograph reading If the reading does not go down in this period then you know that the leak w
75. p 8 liter lines should match where the ends of the chart paper overlap Replace the kymograph drum The pen should rest on the baseline when the spirometer is at rest Note If the pen does not rest on the baseline loosen the kymograph drum support set screw on shaft of drum support with an Allen wrench Raise or lower drum support by tightening or loosening drum adjusting screw on top of drum support with the Allen wrench When pen falls on baseline retighten set screw Enter Baseline check on Daily Spirometer Log Enter if adjustment required 6 6 Time and Leak Check A time calibration should be done to insure that two rotations of the drum take 30 seconds 1 29 7 30 3 seconds 1 Draw a vertical line on the chart paper by raising the bell up and down drawing the line with the pen connected to the bell 2 Type LEA or press F8 to select the Spirometer Leakage Test The computer will prompt Lift spirometer and cork then place weight on bell Press SPACE BAR 3 Raise the spirometer bell to approximately 4 liters and cork the mouthpiece with the 7 rubber stopper 4 Place the weight on top of the spirometer bell to provide a constant pressure within the spirometer 5 Press SPACE BAR The computer will prompt See Figure 2a Enter total time for leakage test default 5 min ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 17 Spirometer Leakage Test Enter total time f
76. participant be referred for further evaluation 8 7 4 Data Storage After the print function is complete the computer will automatically store the test results to two files one on the hard disk and the back up on the archive disk If an unformatted disk is inserted in drive A the computer automatically will go to the formatting procedure See page 51 for a description of formatting and disk labelling After formatting the computer will resume storing the files to the floppy disk The screen will then return to the main Pulmonary Menu 8 7 5 Calibration Date Check Be certain that the date of last calibration printed on the report is correct ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 52 9 DATA MANAGEMENT 9 1 Description A fail safe file management system is provided for quick and easy back up of all data and will prevent accidental erasures The computer will digitize and store the three best flow volume curves and will calculate spirometry results in the file generated for each participant on both the hard disk and a back up floppy disk as soon as the testing is completed If errors occur or power is accidentally lost the data will not be lost However before a floppy disk can be written upon it must be formatted 9 2 Data Disk Formatting Procedure The storage program of the S amp Instruments Pulmo Screen II system requires formatted floppy disks 9 2 1 To format a disk type the comma
77. per Lists of replacement equipment supplies and vendors are in Appendix V 2 1 1 Hardware 1 Collins Survey II spirometer with potentiometer 2 speed kymograph and water drain Collins Cat 006038 2 IBM PC XT with a minimum of 256K of memory a 10MB hard disk and one 360K double sided 5 1 4 floppy disk drive ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 5 3 IBM Color video display monitor with color graphics adapter board including clock calendar 4 IBM Proprinter parallel printer interface card and cable 2 1 2 A D Pulmonary Interface and Software 1 S amp M Instrument Company Pulmo Screen II Pulmonary 12 bit 8 channel A D interface mounted in an expansion slot inside the PC XT 2 S amp M Instrument Company Pulmonary Software a Master disk and backup installed on hard disk drive C b Storage disk drive A ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 3 Page 6 INSTALLATION Before installing the computer read the IBM manual Guide to Operations Sections 1 and 2 Then proceed as outlined below 1 2 Note Remove shipping cardboards from disk drive unit Find the four power switches and turn them off a rear right side of IBM PC XT b top knob on right of IBM color video display monitor screen c front of Collins Survey II spirometer d rear right side of IBM Proprinter Connect keyboard cable to rear of IBM PC XT system uni
78. percent of the forced expiratory vital capacity i e FEF25 is forced expiratory flow rate when 25 of the forced vital capacity has been expired expressed in liters per second 9 Predicted FEV and FVC Based on the equations developed by Crapo 17 with a 12 adjustment for Blacks and Orientals 8 6 8 Data Defaults All FVL data selections are based on current American Thoracic Society recommendations The criteria are 1 FVC FEV 5 Highest value is selected regardless of FEV FE 3 trial in which it occurred PEFR 2 FEV FVC Highest values of FEV FEV and FVC are FEV FVC selected regardless of that 3 FEF25 75 75 85 From curve with highest sum of FVC and FEV FEF25 FEF50 FEF75 4 FVL graph Graph selected from curve with highest sum of FVC and FEV 8 7 Report Generation 8 7 1 Prepare the printer 1 lt A pulmonary function report is to be printed for review by the ARIC clinic physician The report is then filed in the participant s file along with the kymograph tracing 2 Type the letters DAT or press the F3 function key to load the program The screen will display the prompt Prepare PRINTER then Press the SPACE BAR 3 Set the paper in the printer so the first printed line will be just below the perforation for the top of the page This can be done manually or with the top of form set key on your printer consult the User s Manual for your particular printer 8 7 2 Comments After the printer i
79. ponement of the Test eeeeeeeeeeeeeeeeenn ntn JA Positioning the Subject ccc ccc cc eee eee eee ee ee cence eens ree E Demonstration of Procedure cee rere cece ener reece sere nnn 33 Operation of the Flow Volume Loop Program Vite ade a pei 4 34 Quality Assessment eee eee 53s Sat Ses Oi es CSAS Ws 5 Report Generation iesu e ea etu us T Qied sue e iUe eee aUe a 4 aa tg 48 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 iv 9 Data Management eee eee eret ht tn 51 Ol Descriptionoisv4 9 wer veepev vire hb soi rhra ER S beh E Ue a dre are rei 51 9 2 Data Disk Formatting Procedure eee eee eee eee eee rtt 51 9 3 Data Storage Procedures Daily WEISE MP Xe dod as aed i eg 52 9 4 Data Storage Procedures Weekly eee eee eer 53 9 5 Additional Menu Commands ccce eese hh nt 56 10 Cleaning and Maintenance of the Spirometer e 58 10 1 Emptying the Spirometer e cece eee eee nnn n n n n n 58 10 2 Cleaning the Internal Parts cce eee eee eee hern rnt 58 10 3 Cleaning the Breathing Tubes eccellenti 59 11 Data Transfer and Quality Control Procedures eese 60 11 1 Pulmonary Function Data Flow Chart ccc cece ceca eere 60 11 2 Quality Assurance Procedures at the Field Center e 60 11 3 Information Received from the Field Centers eee eee 60 11 4 Data
80. r 6 Measure the tracings of the three best trials Record the FEV and FVC measurements raw and corrected to body conditions BTPS on the tracing See Section 12 1 7 Add a quality code to the tracing 8 Photocopy the tracings and mail the originals to the Pulmonary Reading Center where the curves will be digitized and added to the database Reports of test results will be generated at the Pulmonary Reading Center and sent to the field center for review by the field center physician and for inclusion in the participant s file ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 14 6 INSTRUMENT PREPARATION AND CALIBRATION Each morning prior to participant testing your spirometer system must be checked and calibrated The LEA Spirometer Leakage Check LIN Linearity Check and ADJ Calibration programs will assist you The operator must keep a log of these procedures A 3 0 liter calibration syringe and one way Rudolph valve stopcock are used for the calibration and linearity checks 6 1 Power up the Computer 1 Each morning enter Date Technician Code on Daily Spirometer Log Example on page 15 2 Turn on the master switch on the power strip 3 When all devices are on the monitor should show the Pulmonary Program Menu Figure 1 the power lights on the monitor the printer and the spirometer should be on and the printer on line light should be on 4 Center the speed control on the C
81. r 2 rotations Accept 29 7 30 3 seconds Leak Check ml drop per 2 rotations Accept leak up to 10 cc Linearity Check Accept linearity Record slope up to 0 100 Record linearity Volume Check After connecting open 3 liter syringe Record volume From scrcen From chart paper Add 3 liters and record new volume From screen From chart paper Accept difference of 3 00 L 09 L Record baseline volume From screen From chart paper Weekly Checks Date Volume Number Field Center Empty and clean spirometer Archive Disk Pulmonary Reading Ctr gt Version 7 7 87 Mailer Disk ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 16 6 4 Pen Check The pen line should be easily visible not faint and should be thin Note If it is not change the pen Because of the variable quality of felt tip pens several extras should always be kept on hand If the pens are changed fairly often the reserve pens will remain moist and will make clear lines The cap should always be replaced on the pen at the end of each testing day Enter Pen Line check on Daily Log Sheet Enter if pen required replacement 6 5 Chart Paper and Baseline Checks To load the chart paper remove kymograph drum and carefully align the chart paper around bottom lip of drum Remove and save adhesive backing strip Place right edge of chart paper over the left and smooth adhesive into place The baseline and to
82. r adjustment for age race and smoking 6 Importantly the mortality excess among those with impaired ventilation is due to a variety of causes especially cardiovascular and cancer and not to respiratory causes alone The risk of mortality increases with the degree of spirometry impairment 7 Although the reasons for the association of impaired ventilation with cardiovascular mortality are not known the repeatability of this association and the demonstration of a dose response suggest that the relationship is real and important 8 Spirometry is the simplest most effective and least expensive test for assessment of pulmonary function 9 It is for these reasons that a measure of ventilation spirometry has been included in ARIC Spirometry records the relationship between time and the volume of air that can be exhaled from the lungs The total volume of air which can be exhaled is called the forced vital capacity FVC A measure of how quickly that volume can be expelled is called the one second forced expiratory volume or FEV The volume expired late in the forced expiration three and six second forced expiratory volumes FEV and FEV and flow rates during the course of the expiration peak flow and forced expiratory flows at 25 50 and 75 of the total volume provide additional information about deviations from normal empyting of the lung Most of our information regarding normal pulmonary function comes from cross sectional s
83. rage Programs Patient Directory Review Patient Data Print Patient Directory Print Patient Directory from floppy 6 7 Story Patient Data 8 Copy data from floppy to hard disk 9 Switch Names Id Names Exit to Pulmonary Program Copy stored data to floppy 14 Enter your Selection _ Patient Name SMITH JOHN ID W101234 Date 01 29 1987 Figure 23 DIS Disk Storage Program Menu ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 56 Participant Directory Ordered by ID Numbers ID Numbers Names Date 00 12 12 HEYER ROB 12 17 85 060724 GLAZE DONNA 12 17 85 060724 GLAZE DONNA 12 18 85 12 09 65 FARIS HELEN 12 17 85 275 20 0929 ARNOLD GEORGE 12 18 85 3464545547 CLAIRE 10 03 85 456456456 ADDIE 12 13 85 666 555 444 HART JOHN 12 13 85 9 4 3 Print Directory of Archive Disk Press 7 Print a listing of the contents of the archive disk by pressing 7 Verify that the listing from the archive disk contains the same participants as the listing from the hard disk Then remove the archive disk from drive A and store for 10 weeks 9 4 4 Download Hard Disk to Mailer Change disks press 5 Insert a new diskette formatted with the appropriate batch code label in drive A The number in parentheses which appears after the procedure on the Disk Storage Program menu is the number of participant files which are on the hard disk and which will be copied to the floppy disk Press 5 to copy data
84. rams 8 6 1 Acceptability Acceptable spirograms are defined by the performance of a maximal inspiration which completely fills the lungs followed by a subsequent forceful complete and smooth expiration which reaches a plateau To be acceptable two of the three best spirograms highest sum of FEV FVC see F9 above must have none of the following errors 8 6 1 1 Acceptability Codes These errors in test performance are identified and labelled with the following codes at the Pulmonary Function Reading Center from two of the three best spirograms These acceptability codes appear on hard copy reports to the field centers and the Coordinating Center See Acceptability code detail pp 64 66 Spirometer not calibrated correctly Computer started after start of expiration Breath hold leak gt 5 of FVC Submaximal effort rounded peak on FVL loop Cough inhalation present No plateau and tests not carried to 10 seconds Low water level in spirometer Flow volume loop not stored either a manual entry or test started too long after space bar was pressed ONAU EWN I ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 37 Trial 1 Actual FVC 1 5 43 FEV 1 4 70 FEF25 75 1 S 5 70 PEFR 1 s 11 15 Trial 2 Actual FVC 1 3 76 FEV 1 0 3 31 FEF25 75 1 S 4 48 PEFR s 8 67 1l 2 3 4 Bye Press SPACE BAR for FVL or ESC for Pulmonary Menu Figure 11 FVL Screen obtaine
85. re and Atmospheric Pressure Completely Saturated with Water Vapor at Body Temperature 12 2 8 1 BTPS to STPD PB 47 760 X 273 310 12 2 8 2 BTPS to ATPS PB 47 PB PH20 X 273 T 310 12 2 8 3 BTPS to ATPD PB 47 PB X 273 T 310 12 2 9 STPD Standard Temperature and Pressure Dry 12 2 9 1 STPD to BTPS 760 PB 47 X 310 273 12 2 9 2 STPD to ATPS 760 PB PH20 X 2734T 273 12 2 9 3 STPD to ATPD 760 PB X 273 T 273 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Appendix I Sample Reports A Weekly Report from field center to Pulmonary Function Reading Center 1 Log sheet 2 Listing of mailer disk 3 10 sample of spirograms B Weekly Progess Report to the field center from the Pulmonary Function Reading Center 1 Summary page which includes a Confirmation of records and tracings received b Proportion of acceptable records and tabulation of problems among the unacceptable records c Proportion of agreement between field center and Pulmonary Function Reading Center quality codes d Proportion of acceptable calibrations 2 Electronic evaluation of acceptability and quality 3 Hand measured evaluation of randomly selected spirograms 4 Flow volume plot of randomly selected spirograms C Weekly Report to Coordinating Center from Pulmonary Function Reading Center 1 Listing of participants whose processed records were included on floppy disk 2 Copy of field center report as noted abo
86. reen will flash some messages very quickly before bringing up the S amp M logo and the Main Pulmonary Menu screen ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 8 4 COMPUTER SOFTWARE 4 1 General Information Before Beginning Procedure 1 All boards should be properly installed and cables connected before turning on power to any component 2 Familiarization with keyboard will help locate keys used often in the operation of the program a Space bar this key is used to begin and end on line tests as requested throughout the program b ESC ESCAPE is used to exit from any program and to return to the MENU The Escape key should not be used to end spirometry data collection flow volume loop or to exit from the middle of a Screen entry i e participant information as ESC will interrupt the program and these entries will not be stored c ENTER is used to end data entry from the keyboard A good rule to follow is to press ENTER whenever the cursor is blinking and the information in the field is completely entered d Y N this option would require a Yes or No answer The letter Y or N is all that is required e Function Keys Function keys are located across the top of the keyboard and are labelled Fl through F12 The specific use of these keys will be described later in this manual f PrtSc The Print Screen key will print the displayed screen to the printer 3 To format disks for data
87. s tracings reproducible but irregular 3 spirograms last less than 6 seconds tracings reproducible smooth with continuous transition of slope 4 spirograms last less than 6 seconds tracings reproducible but irregular 5 spirograms not reproducible 9 unable to assess quality Status Code Blank 11 6 The Coordinating Center will respond to the Pulmonary Function Center by doing the following 1 Acknowledge receipt of the diskette from the Pulmonary Function Reading Center with a pre printed postcard to which they will add a date and a count of the records received ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 70 FIELD CENTERS Subject Enrollment Respiratory and smoking questionnaire Anthropometry Spirometer preparation and calibration Participant identification Spirometry Data Management Weekly Transmittal to CC Archive weekly copy of pulmonary data disk Weekly transmittal to PRC Mailer disk of pulmonary data Listing of mailer disk contents Spirometer calibration log Listing of 10 random sample Spirogram tracings from 10 sample Inventory record for each participant Calibration log PULMONARY READING CENTER Calibration and standardization checks Acceptability and reproducibility checks of electronic tracing Hand measure 10 sample of spirogram tracings Data management Statistical quality control of group field center data Rep
88. s ESC Linearity Check Having pressed the SPACE BAR after successfully completing the Time and Leak checks the screen in Figure 3a should now appear on the display If you are entering the Linearity Check program from the Pulmonary Program Menu type LIN or press F7 The 3 liter calibration syringe the Rudolph 2150 stopcock and tubing normally stored next to the spirometer will be used at this time Flush the 3 liter syringe back and forth with room air several times then flush the spirometer twice with room air and stop at zero volume This ensures that the syringe and spirometer contain air at the same temperature Set the 3 liter syringe to the l liter position by a Opening the syringe past the l liter mark Figure 4a b Using the Allen wrench to loosen the moveable SILVER locking collar and move it to the l liter mark Figures 4b and 4c Turn the arrow on the Rudolph valve counterclockwise until it stops Attach the SHORT LENGTH OF TUBING to Rudolph VALVE PORT POINTED AT BY THE ARROW Attach the OPPOSITE VALVE PORT to the breathing tube of the spirometer Figure 4d Attach the 3 liter syringe to the SHORT LENGTH OF TUBING Figure 4e ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 20 Linearity Check Count Volume Spirometer Position 1 53 0 11 Connect 2 way valve and open syringe per instructions press SPACE BAR Figure 3a Linearity Check Linearity Results
89. s prepared for final report press ENTER or use above options to enter comments The prompt will be ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 49 Enter Comments for Line 1 Enter your comments on the keyboard up to 80 characters screen width and press ENTER A second line of comments can be entered with the prompt being Enter Comments for Line 2 Again you may enter up to 80 characters and then press ENTER If no comments are to be entered then press ENTER only for each prompt above The final prompt before printing report will be How many copies Enter the number of copies of the printed report and interpretation See Figure 22 you wish to print then press ENTER or press the ENTER key to print the default of one 1 copy 8 7 3 Computer Impression The computer will compare the observed values to those predicted by the Crapo regression 2 The following are the criteria for restriction and obstruction Ly Mild restriction FVCZ of predicted is less than 80 and greater than or equal to 66 in the presence of a normal FEV FVC ratio 2 70 2 Moderate restriction FVCZ of predicted is less than 66 and greater than or equal to 51 in the presence of a normal FEV FVC ratio 2 70 3 Severe restriction FVCZ of predicted is less than 51 of predicted in the presence of a normal FEV FVC ratio 2 70 4 Mild obstruction the ratio of FEV to FVC is less than 70 and great
90. sampling Computers Biomed Res 1984 17 229 240 Ferris BG The Epidemiology Standardization Project Report No HR 53028 F National Heart Lung and Blood Institute Division of Lung Diseases 1978 Gardner RM et al ATS statement Snowbird workshop on standardization of spirometry Amer Rev Respir Dis 1979 119 831 Gardner RM Hankinson JL West BJ Evaluating commercially available spirometers Am Rev Respir Dis 1980 121 73 Gardner RM Crapo RO Billings JW Shigeoka JW Hankinson JC Spirometry what paper speed Chest 1983 84 161 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 A 98 Tockman MS Results of pulmonary function tests exercise tests and blood gas analyses performed at IPPB study centers site visits May June 1981 Report to IPPB Advisory Board National Heart Lung and Blood Institute Division of Lung Diseases October 1981 Stead WW Wells HS Gault NL and Ognanovich J Inaccuracy of the conventional water filled spirometer for recording rapid breathing J Appl Physiol 14 448 450 1959 Ferris BG Jr Speizer FE Bishop Y Prang G Weener J Spirometry for an epidemiologic study Deriving optimum summary statistics for each subject Bull Europ Physiopath Resp 14 146 166 1978 Crapo RO Morris AH Gardner RM Reference spirometric values using techniques and equipment that meet A
91. screen and then type INI The screen displays the message INITIALIZING PARTICIPANT FILES followed by the MENU display again The field center name will now appear throughout the program and on the final data sheet CAUTION If initialize INI is run on a previously used i e reconfigured disk ALL STORED PARTICIPANT DATA AND CALIBRATION ADJUSTMENT FACTORS ARE REMOVED PERMANENTLY It is therefore suggested that any INI command be followed immediately by the ADJ CALIBRATE VOLUME and FLOW procedure to assure accurate spirometry results After a new disk is initialized run ADJ before beginning any participant testing ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 A 93 Appendix IV Prediction Equations Prediction Equations MALE age equal to or greater than 25 Parameter Equation Reference FVC 0 0600H 0 0214A 4 650 Crapo FEV 0 0414H 0 0244A 2 190 Crapo FVC 0 065H 0 29A 5 459 Knudson FEV 5 0 037H 0 017A 2 746 Knudson FEV 0 052H 0 027A 4 203 Knudson FEV 0 063H 0 031A 5 245 Knudson FEV FVC 0 087H 0 14A 103 64 Knudson FEF200 1200 0 28H 0 47A 2 01 Morr s PF 0 094H 0 035A 5 99 Knudson FEF25Z 0 088H 0 035A 5 618 Knudson FEF50Z 0 069H 0 015A 5 4 Knudson FEF75Z 0 044H 0 012A 4 143 Knudson FEF25 75 0 045H 0 031A 1 864 Knudson FEF75 85 0 03H 0 023A 1 21 Morr s Height expressed in centimeters ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1
92. sion 1 pages updated pages added or pages deleted are indicated as Versions 1 1 1 2 and so on and are described in detail in the Revision Log located immediately after the title page When revisions are substan tial enough to require a new printing of the manual the version number will be updated e g Version 2 0 on the title page ARIC Study Protocols and Manuals of Operation MANUAL TITLE 1 General Description and Study Management 2 Cohort Component Procedures 3 Surveillance Component Procedures 4 Pulmonary Function Assessment 5 Electrocardiography 6 Ultrasound Assessment 7 Blood Collection and Processing 8 Lipid and Lipoprotein Determinations 9 Hemostasis Determinations 10 Clinical Chemistry Determinations 11 Sitting Blood Pressure and Postural Changes in Blood Pressure and Heart Rate 12 Quality Assurance ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 wu mif Ne Un Ui ui WN a DAAAAAAA OnNaAUNLPWNH I MM Ne eo NOONE WHF o OO OO OO OO OO CO iii Pulmonary Function Assessment Introduction eene Re eR e E gr P aw S ex ui tes roa ie oral The Importance of Pulmonary Function Testing in ARIC 1 Description of the Pulmonary Function System eive 9S iate 2 Pulmonary Equipment ee eee Us v ES Va epe wisis ie Sues es red Description eee eee eene ntt Nd Pm VU eT ede sue dd Installation leere eee nnn nn
93. sition of the BLACK COLLAR has been calibrated at the factory to allow the delivery of a 3 liter volume when the silver collar is locked into place against it DO NOT ADJUST THE POSITION OF THE BLACK COLLAR 4 Turn the arrow on the Rudolph valve counterclockwise until it stops Attach the SHORT LENGTH OF TUBING to Rudolph VALVE PORT POINTED AT BY THE ARROW Attach the OPPOSITE VALVE PORT to the breathing tube of the spirometer Figure Ad 5 Attach the 3 liter syringe to the SHORT LENGTH OF TUBING Figure 4e ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 8 6 01 88 Page 29 7 PARTICIPANT INFORMATION 7 1 Entering Information on Computer Identifying information for each ARIC subject will be entered from the computer keyboard in response to prompts from the participant information program INF INF is accessed from the MENU by typing INF or pressing Fl Enter the information requested on each line ending each entry with ENTER key Every item MUST BE ENTERED in order to calculate predicted values accurately See Figure 8 1 DATE will be read from the computer s internal clock 2 TIME will be read from the computer s internal clock 3 NAME a minimum of three letters must be typed in last and then first name with a maximum of 23 characters USE THE SPACE BAR TO SEPARATE LAST NAME FROM FIRST NAME Do NOT use a comma The technician should verify with the participant that the name listed on the participant s fol
94. storage see page 51 4 2 Pulmonary Program Menu Description When the computer is started the main Pulmonary menu will be displayed See Figure 1 The programs are started by typing in the 3 letter program name or by pressing a function key The function key for each of the programs is Fl INF F2 FVL F3 DAT FA CAL F5 ADJ F6 DIS F7 LIN F8 LEA description of each program follows ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 9 Johns Hopkins University Pulmonary Program Menu Enter Patient Information FVL Flow Volume Loop Patient Data Sheet CAL Check Calibration Calibrate Flow amp Volume DIS Disc Storage Program Linearity Check LEA Spirometer Leakage Check Enter PROGRAM you wish to Run Figure 1 Pulmonary Program Menu ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 10 4 2 1 INF Participant Information This program is for entering participant anthropometrics which are used to calculate predicted values It is essential that this program be run before performing any on line tests on a participant 4 2 2 EVL Flow Volume Loop This program runs the on line participant spirometry testing Flow volume loops are displayed on the video screen in real time for quality control Volume time spirograms are generated in real time on the Collins spirometer 4 2 3 DAT Participant Data Sheet Selection of this program at the
95. surements with computer s measurements Prepare report for Coordinating Center on data being transmitted and on status of quality codes reproducibility and calibration for each Field Center see page 93 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 74 ARIC Coordinating Center Pulmonary Function Procedures COORDINATING CENTER Data Management Add formatted files of individual spirometric flow and volume received from Pulmonary Reading Center to database Backup files Erase files from floppy disks and return to Field Centers for future data transfers Reports Prepare report to Pulmonary Reading Center on files received from the Field Centers Prepare report to Field Centers on files received from Pulmonary Reading Center ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 12 12 1 1 12 2 12 2 12 2 ARIC Page 75 TERMS AND SYMBOLS General STPD Standard conditions temperature at 24C barometric pressure 760 mmHg 760 torr and dry 0 torr water vapor BTPS Body conditions Body temperature usually 37C ambient barometric pressure and saturated with water vapor usually 47 torr water vapor at these conditions ATPD Ambient temperature pressure and dry ATPS Ambient temperature pressure and saturated with water vapor BP Barometric pressure usually in mmHg or torr C Degrees Centigrade F Degrees Fahrenheit 1
96. t back panel round socket insert plug with notch up Connect power cable 3 hole sockets into plugs on back panels of a IBM PC XT system unit b IBM video display monitor and c IBM Proprinter Connect data cables to rear of a IBM Proprinter back panel right side b Collins Survey II Spirometer Connect free ends of data cables to rear of IBM PC XT system unit in the following slots numbered from the RIGHT side a Slot 1 Spirometer Cable b Slot 2 free c Slot 3 Printer Cable d Slot 4 Video Monitor Connect all power lines to the grounded AC power strip or other grounded outlets A minimum of four outlets are needed for the system if a power strip is not used Install paper in printer as directed in printer user s manual pp 3 13 At this point all components of the system should be connected and can be turned on The following step has been performed for you Do not repeat unless instructed to do so ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 7 10 To install the S amp software on the hard disk do the following a Insert S amp M disk in drive A b Type A UPLOAD The screen will show names of the programs being copied from the floppy disk to the hard disk When the UPLOAD is complete a message about the number of files that were copied will appear on the screen c Remove disk from drive A d Press Ctrl Alt Del keys simultaneously The sc
97. tach a clean breathing tube to the breathing tube connector 10 3 Cleaning the Breathing Tubes Clean the breathing tubes after each day s testing Cleaning the breathing tube involves soaking it in a disinfectant solution After disinfecting rinse the tube thoroughly and allow it to dry completely overnight before reusing ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 61 2 11 DATA TRANSFER AND QUALITY CONTROL PROCEDURES 11 1 Pulmonary Function Data Flow Chart A flow chart summary of data items transferred between the field centers the Pulmonary Function Reading Center and the Data Coordinating Center may be found on page 69 Sample reports may be found in Appendix I page A 76 11 2 Quality Assurance Procedures at the Field Center 11 2 1 Technician Training Each technician has completed an intensive two day training course in spirometric testing which meets the criteria for National Institute of Occupational Safety and Health NIOSH certification In addition each ARIC pulmonary function technician has received training in the ARIC Pulmonary Function Testing Protocol using ARIC pulmonary function calibration and test equipment computer hardware and software Each ARIC pulmonary function technician has been certified in his her abilities in Familiarity with the ARIC protocol Preparation and calibration of spirometry hardware and software Participant instruction Spirometry testing techniq
98. tem S amp Instrument Company have been installed on the hard disk of the IBM PC XT computer The computer will assist the operator in calibration spirometric testing and analysis An IBM Proprinter is connected to the computer for report generation The testing of each ARIC study participant will produce the following results 1 A labelled spirogram paper tracing from the Collins spirometer 2 A spirometry summary and interpretation paper report from the IBM Proprinter 3 Hard disk primary storage of the three best spirograms digitized with calibration and identifying variables and calculated spirometry results 4 Floppy disk back up storage of the record described in number 3 No knowledge of programming or computers is required to operate this system The system is driven by MENU screens from which the technician selects the desired activity The operator will begin a calibration check program every time the system is restarted each morning The calibration check program will include a test for leaks in the system a volume calibration with a 3 liter syringe a time calibration with a stopwatch and a linearity check The results of the calibration checks the date the time and technician s code will be stored on the hard disk The calibration check program is described in detail in Chapter 6 A log of the calibration results will also be maintained by the technician at each field center As the subject blows in
99. ter and the predicted values will be changed on the computer file ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 32 8 PARTICIPANT SPIROMETRY TESTING The technician is the critical part of the pulmonary function testing system since he she must guide the subject through the forced expiration a maneuver which is highly dependent on subject effort The technician must coach the partcipant both to maximal inspiration as well as to maximal expiration The technician also must judge the acceptability and quality of the subject s effort To make the spirometric testing results as accurate and consistent as possible the testing should be done in a standardized fashion by each technician and every subject 8 1 Explanation of the Procedure Prior to testing instruct the participant on proper performance of forced expiration maneuver Explain to the participant that he is about to do a test to determine how much air he can inhale and how hard and fast he can exhale it Example Like blowing out birthday candles 1l Explain to the participant that he will a attach the noseclip b take in as deep a breath as possible and when full will c place the mouthpiece between his teeth d close his lips tightly around the mouthpiece and e exhale his air through the mouthpiece into the spirometer pushing the air out as hard fast smoothly and completely as possible until told by the technician to stop exh
100. the hand measured results from the field center see Appendix I 4 Flow volume plot of randomly selected spirograms B Weekly Report to Coordinating Center from Pulmonary Function Reading Center 1 Listing of participants whose processed records were included on floppy disk 2 Copy of field center report as noted above except 2 7 Based upon race and sex specific regressions generated from healthy non smoker pulmonary function measurements a Statistical quality control will be performed on the grouped data of each field center b Normal pulmonary function regressions will be calculated for each field center 11 5 File Format for Pulmonary Function Test Records The files will then be reformatted into fixed length ASCII records with the following format Columns 1 7 8 12 13 15 16 17 18 19 20 21 22 23 24 25 42 43 44 45 52 53 57 58 60 ARIC PROTOCOL 4 Contents Participant ID Blanks Form Code PFT Version A Record Type D ARIC Study Code 30 Record type numeric code 13 Record type version number 0 A 0 B 1 etc Contact Year Blanks Update level A two digit numeric field which identi fies which revision of the record this is Every record begins as update level 00 when created Each time changes are made to a record the update level is incremented by 1 Date of Record Creation MM DD YY Time of Record Creation HH MM 24 hour clock BLANKS Pulmonary Fun
101. tion syringe Repair replace the syringe ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 26 Press SPACE BAR after third stroke Figure 6a Volume Calibration Check Screen 3 Adjustment complete Press SPACE BAR to continue Figure 6b Volume Calibration Check Screen 4 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 27 Johns Hopkins University Instrument Calibration Check Last Calibration was 01 29 87 Volume 1 83Lliters Flow 0 01 Liters Second Press SPACE BAR to Return to Menu Figure 7a Volume Calibration Check Screen 5 Johns Hopkins University Instrument Calibration Check Last Calibration was 01 29 87 Volume 4 83 Liters Flow 0 03 Liters Second Press SPACE BAR to Return to Menu Figure 7b Volume Calibration Check Screen 6 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 28 Any abnormally large number less than 20 00 liters sec or greater than 420 00 liters sec may indicate a problem with the flow channel of the S amp M Instrument Pulmo Screen A D interface Contact the S amp M Instrument Company for repair Notify the Pulmonary Function Reading Center and mark the tracings Flow calibration incorrect ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 29 7 PARTICIPANT INFORMATION 7 1 Entering Information on Computer Identifying informat
102. to the subject s tongue being inserted in the mouthpiece or in glottis closure Instead the technician should urge the subject continually to push or squeeze his air out 8 The end of the test is best seen on the spirogram The end of the test is reached when the participant s spirogram on the Collins spirometer reaches a plateau no volume increase after at least six seconds PRESS SPACE BAR AT END OF TEST Computer displays Figure 10 9 Have the participant perform a total of five forced expirations To do another test on the same participant press the SPACE BAR e g Figure 10 To return to the pulmonary MENU press the ESC key 10 It is the technician s responsibility to determine that the two best FEV s and two best FVC s are reproducible within 5 The computer can assist this decision in the following ways a The computer screen Figure 10 will indicate when at least two FVC s are within 5 The computer only looks at FVC for reproducibility The technician must examine the two best FVC and the two best FEV for reproducibility b After the 3rd ath and 5th trials F9 should be pressed to display data and graphs for evaluation ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 35 Press SPACE BAR to start FVL test Figure 9 FVL Screen 1 Name SMITH JOHN Flew Ls B Date 01 29 87 Study ARIC nu Trial 5 Actual iz FVC 1 5 47 is FEV 1 1 3 87 FEV 1 FVC X 71 8 FEV 3 1 4
103. to the spirometer the spirogram paper will display a volume time tracing while the computer displays real time flow volume curves for operator assessment of acceptability Simultaneously the computer will make multiple quality measurements of each maneuver A message will be displayed when at least two out of three maneuvers are reproducible FVC s within 52 During the five spirogram trials the technician will attempt to obtain three acceptable spirograms of which the best two are reproducible within 5 The computer will assist this determination by displaying the best three maneuvers graphed as flow volume curves superimposed at maximal inhalation volume TLC Each maneuver will be separately identified on the display The computer will indicate which maneuver it thinks is the best one and will indicate when a sufficient number of acceptable and reproducible maneuvers have been obtained The technician will confirm this selection by observing the volume time spirograms produced directly by the Collins spirometer ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 3 The computer will print a summary of the subject s results from the data file at the end of each session and then store the raw data from each maneuver in the file generated for that subject on both the hard disk and a back up floppy disk The summary report and spirogram paper tracing are stored in the participant s file At the end of the week the
104. tober 1986 This calibration factor will be re established annually at the time of the recertification visit e The volume time curves are standardized to a 3 liter syringe volume common to all the field centers repeated during the annual standardization visit and spirometric indices will be calculated and stored 4 A file containing the reformatted standardized pulmonary function data will be copied to a diskette with an internal and external ARIC batch number label to be sent to the Coordinating Center each week along with a listing of the disk directory 5 The paper tracings of a 10 sampling of participants will be hand measured and the results compared with those from the field center 6 A report of the quality control check will be sent to the field centers with a copy to the Coordinating Center See sample reports in Appendix I A Weekly Progess Report to the field center from the Pulmonary Function Reading Center 1 Summary page which includes a Confirmation of records and tracings received b Proportion of acceptable records and tabulation of problems among the unacceptable records c Proportion of agreement between field center and Pulmonary Function Reading Center quality codes d Proportion of acceptable calibrations ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 64 2 Electronic evaluation of acceptability and quality 3 Hand measured evaluation of randomly selected spir
105. ts of age Am Rev Resp Dis 1976 113 587 600 Cotes JE Lung Function 2nd Ed FA Davis Philadelphia 1968 1978 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 A 99 29 Schmidt CD Dickman ML Gardner RM Brough FK Spirometric standards for healthy elderly men and women Am Rev Resp Dis 1973 108 933 939 30 Gaensler EA and Wright GW Arc Envir Hlth 1966 12 146 189 31 Altman PL Dittmer DS eds Respiration and Circulation Biological handbooks Bethesda Maryland Fed of American Societies for Experimental Biology 1971 126 32 Morris AH Kanner RE et al eds Clinical Pulmonary Function Testing lst and 2nd edition Salt Lake City Intermountain Thoracic Society 1975 33 Dickman ML Schmidt CD Gardner RM Spirometric standards for normal children and adolescents age 5 through 18 years Am Rev Resp Dis 1971 104 680 687 34 Gaensler EA Evaluation of respiratory impairment Arch Envirn Hlth 1966 12 146 189 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 ARIC PROTOCOL Manual 4 Pulmonary Function Assessment Version 1 8 Update Provided July 1 1988 THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL Collaborative Studies Coordinating Center CB 8030 Suite 203 NCNB Plaza Department of Biostatistics The University of North Carolina at Chapel Hill School of Public Health Chapel Hill N C 27514 4145 MEMORANDUM TO ARIC Principal Investigators and Study
106. ues Assessment of tracing acceptability and reproducibility Data management and transfer procedures Calculation of spirometric parameters SOUP WN FE Only ARIC certified technicians are to perform pulmonary function testing in this study To retain their certification technicians must be responsible for one full day of testing per week or equivalent one complete calibration plus tests on six participants Annual recertification is to be conducted at each field center 11 3 Information Received from the Field Centers Each week the Pulmonary Function Reading Center will receive the following from each of the field centers l One mailer diskette containing the pulmonary function data files for the previous week s testing 2 A listing of the mailer disk directory for the previous week s testing ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 11 4 Upon Page 62 A copy of the DAILY SPIROMETER LOG for the week The listing of the 10Z random sample of participants for the week The actual tracings for a 10 sample of participants tested during the previous week with the raw and BTPS corrected values see Section 12 for BTPS correction factor for FEV and FVC of the three best spirograms Data Management Procedures at the Pulmonary Function Reading Center receiving the packages the Pulmonary Function Reading Center will do the following l ARIC Verify the contents of the diskettes
107. urveys of normal populations Predicted values based upon height age sex and race may be generated and compared with the observed values of ARIC study participants The Epidemiology Standardization Project 10 the Snowbird workshop on standardization of spirometry 11 and further evaluations of commercially available spirometers 12 have indicated the importance of using a volume displacement spirometer the type of spirometer to be used by ARIC Both the Epidemiology Standardization Project 10 and the American Thoracic Society 11 have issued statements which provide criteria for spirometry test performance and for manual measurement However manual measurements are tedious and prone to error 13 Also deviations in test performance and lack of regular leak checking and calibration can result in loss of study data 14 Microprocessor computer systems are now being extensively used in spirometry to assist the pulmonary technician with quality control of test performance measurement analysis and interpretation 9 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 Page 2 1 2 Description of the Pulmonary Function Measurement System The pulmonary function measurements in the ARIC study are to be made on a Collins Survey II volume displacement spirometer which is connected to an IBM PC XT computer through a 12 bit analog to digital A D interface The calibration and analytic programs of the Pulmo Screen II sys
108. ve except 2 Electronic Evaluation of Acceptability and Quality field center Washington Co MD Date 07 17 1987 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 1 7 7 10 87 DAILY SPIROMETER LOG Instructions Complete this form every day Keep this form in your spirometry notebook and send a good photocopy to the Pulmonary Reading Center and to the Coordinating Center weekly Dally Checks Date Technician Code Cole ee el Torker S t g 3 Pen Line width intensity Check if acceptable star if pen replaced Baseline Check if acceptable Star if correction needed Time Check Seconds per 2 rotations Accept 29 7 30 3 seconds Y X D E 9 32 S QS vs e jo D leis Leak Check ml drop per 2 rotations Accept leak up to 10 cc Linearity Check Accept linearity Record slope up to 0 100 Record linearity Volume Check After connecting open 3 liter syringe Record volume From screen 2 51 From chart paper 3 02 3 43 Add 3 liters and record rid sd 6 26 2 6 58 From chart paper 6 0 Accept New Volume of 2 91 3 09 L Record baseline volume From screen From chart paper Disconnect and clean hose kly Checks Date Volume Number Field Center Archive Disk A C w P 0009 Empty and clean spirometer 1 p 2 ET 4 X Pulmonary Reading Ctr Mailer Disk AR wP 0066 Version 4 6 87 ARIC PROTOCOL 4 Pulmonary Fun

ARIC Manual 4 - CSCC - The University of North Carolina at Chapel

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