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ARIC Manual 4

1. eee Weg iex V dd eyenels NC d PU 35 8 Participant Spirometry Testing eee eee eee ere 38 8 1 Explanation of the Procedure cece eese eese eso ees JB 8 2 Positioning the Subject WUOCR S ub Ce n eR EUR S S ee 38 8 3 Demonstration of Procedure e ue eue e a o erre Re RS EA CI 3 8 4 Operation of the Flow Volume Loop Program eene 39 8 5 Quality Assessment eb n wwe kiss os VE e eio eie o vias 8 6 Operation of the Maximal Respiratory Pressures Program 54 8 7 Report Generation ve 99 s SUR e evs Stale oe VANUS S dcvca P recu e eie Rue n 55 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 11 1 11 2 11 3 11 4 11 5 iv Data Management eee rn en OU Description eshte ined eoe die dete ete e esee tee Gris tans I pec 61 Data Disk Formatting Procedure eee eee eee eee nnn 61 Data Storage Procedures Daily eee eee een nnn nn ns 62 Data Storage Procedures Weekly 3533 58 6 87 Ye PEREAT 63 Additional Menu Commands AUS DR fda RAO OP EK Eia RU RA eee 6 66 Cleaning and Maintenance of the Spirometer D Nein Ria wee A S eS 68 Emptying the Spirometer Sende eru e wear Sa UNE AR SLICE TUUS ie Sie PRU 68 Cleaning the Internal Parts T Ee E Saas 68 Cleaning the Breathing Tubes seb ael s PEOR Data Transfer and Quality Control Procedures
2. wo con on ul 12 INSPIRED to EXPIRED LOOP MUST BY 802 1 Inspired to Expired Loop must be 807 2 Inspired to Expired Loop must be 852 3 Inspired to Expired Loop must be 90Z 4 Inspired to Expired Loop must be 95Z Ratio of FIVC FEVC must be a minimum of 80Z for inspiratory flows to be calculated Less than 80Z 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 NOUS WN ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 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 l The field center name which appears on the final Participant Data Sheet i 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 t
3. cec ee ees 70 Pulmonary Function Data Flow Chart eee eee eene htt 70 Quality Assurance Procedures at the Field Center 70 Information Received from the Field Centers cele 70 Data Management Procedures at Pulmonary Function Reading Center eee eee ee eee eerta pax sw Coordinating Center s Response to Pulmonary Function Reading Center eee eee erri i ooo oto vs 723 Terms and Symbols ccce eee e sooo 79 General VER Vii een OU T Ve e ET wale eS ee Ce ED Sq Equations eceska e hu hh S000 0S Y ac RI Cee S n n e XR eA eile ek nies Wie E 79 Appendices 1s o yes og ko uae IR RUN E e vie ee A 81 Sample Reports cccscccccccscccccccesecccrssssccccsseesescses ce 781 Troubleshooting ee nce Soa EUR ec rr 92 Configuration d Set up Routine i e or v rr s OR OSS A 94 Prediction Equations ce eere ee ea vals v s esr execs ev M UE ea 0 A 97 Equipment Supplies and Vendors eee eee eee eoo AC09 References eee eve te E een aeae eee LEE SE 9 9 9 9 9 9 ee e A 101 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 1 1 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 w
4. Figure 2a Time and Leakage Check Spirometer Leakage Test Initial Volume 7 66 Liters Current Volume 7 60 Liters Time 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 2 0 October 1990 Page 20 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 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 Note If time check falls outside acceptable range check connection to power source and check that the chart paper is not slipping on the kymo
5. 18 19 21 22 23 24 25 42 43 44 45 52 53 57 58 60 61 68 69 73 74 75 77 78 83 84 98 99 138 140 141 A 101 Format for Pulmonary Function Records reformatted into fixed length ASCII records with the Note that these formats may be changed at some point necessarily being revised Please contact the to verify the current layout Contents Participant ID Blanks Form Code PFT Version B Record Type D ARIC Study Code 3 Record type numeric code 086 Record type version number 1 A 0 B 1 etc Contact Year 04 Blanks Update level A two digit numeric field which identifies 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 Date of previous record MM DD YY Blank if no previous record Time of previous record HH MM Blank if no previous record Transaction type A Add a new record C Change the record D Delete the record 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Co
6. Yes 1 1 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 ARIC Quality Control Report for Randomly Selected Spirograms in Washington County Maryland Date of Test 07 08 87 TECHNICIAN 026 PARTICIPANT 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 eect HAVE PREVENTED BOTH PROBLEMS LEAK amp SUBMAXIMAL ORT 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 2 51 0 00 Comparison of Measured Results to Computer Results MEASURED COMPUTER DIFFERENCE FVC 2 98 8 05 2 35 FEV 2 51 2 52 0 40 Differences lt 3 are acceptable ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 oo T lt LART G ar 4200 E LOGS e 9E E 82 E 42 22 068 0 6TO 68F c GE eve 68 88 GBE T EVO E aria c EE E v OE 8 e00 T SMOT J agedo s eud JP X 4 JFT F UOFSFA P 7 WNnT OA eed JTP X JAS tAad MOT 88d edor8s ed etBuy TOA eeg x JAS TAJd i MOT Jead a
7. 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 WEEKLY PROGRESS REPORT FROM 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 FEV1 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 100 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 1 3 100 Chart paper 2 91 3 09 L 3 100 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Electronic evaluation of Acceptability amp Quality Acceptability codes l Spirometer not calibrated correctly 2 Computer started after start of expiration 3 Breat
8. 354 356 A 104 Contents Race O white l 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 Predicted Staf s Code FEF 0 Predicted Status Code FEF 5 Predicted States Code FER 75 Predicted Status Code File Name of Pulmonary Function Reading Center system Status Code Blanks FEV FVC Predicted Status Code Blanks BTPS corrected volumes 357 364 365 366 373 374 375 382 383 384 391 392 ARIC PROTOCOL 4 FVC liters Status code FEV 5 liters Stalag Code FEV liters Status Code FEV liters Status Code Pulmonary Function Assessment Version 2 0 October 1990 Columns 393 400 401 402 409 410 411 418 419 420 427 428 429 436 437 438 445 446 447 454 455 456 463 464 465 472 473 474 481 482 483 490 491 492 496 497 498 499 500 504 505 506 ARIC PROTOCOL 4 A 105 Contents FEV liters Status Code FEV FEV Status Code FEV FVC Stafa Code FEV FVC Status Code FEV FVC Status Code Date of last calibration Status Code PEFR Status Code FEF Status Code FEF Status Code FEF States Code FEF Statas Code Time of last calibration Status Code Acceptability Code a
9. Contact the S amp M Instrument Company for repair Notify the Pulmonary Function Reading Center and mark the tracings Flow calibration incorrect 6 9 Maximal Respiratory Pressure Transducer Calibration Check On the first day of participant testing for the week eg Monday run the MRP calibration after the spirometer calibration procedures Regular MRP calibration is required since the pressure transducer may drift due to changes in temperature and aging of the transducer 1 Press F3 Maximal Respiratory Pressure MRP from the Pulmonary Program Menu 2 Press 3 Calibrate Pressure Transducer from the Maximal Respiratory Pressure Menu The screen will show figure 8a 3 Detach the MRP mouthpiece and tubing from the front of the MRP unit replacing it with the 5 cc calibrating syringe and tubing 4 Adjust the syringe until the aneroid pressure gauge reads 0 then press the spacebar 5 Push in the syringe until the gauge reads 160 cm H0 Press the spacebar when the gauge reads exactly 160 cm H0 6 Pull out on the syringe until the gauge reads 160 cm H40 When the gauge reads exactly 160 cm H50 press the spacebar 7 The MRP calibration results screen Calibrate Pressue Transducer figure 8b will demonstrate the results and the date of the previously saved calibration as well as the new calibration results 8 Record the dates of the previous and current calibrations as well as the positive and negative errors on the Da
10. 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 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 The time of the exhalation will be displayed on the screen Figure 11 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 12 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 12 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 repr
11. 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 Morris Height expressed in centimeters ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Prediction Equations FEMALE age equal to or greater than 20 Parameter Equation Reference FVC 0 0491H 0 0216A 3 590 Crapo FEV 0 0342H 0 0255A 1 578 Crapo FVC 0 37H 0 022A 1 774 Knudson FEV s 0 019H 0 014A 0 406 Knudson FEV 0 027H 0 021A 0 794 Knudson FEV 0 035H 0 023A 1 633 Knudson FEV FVC 0 11H 0 109A 107 38 Knudson FEF200 1200 0 37H 0 036A 2 532 Morris PF 0 049H 0 025A 0 735 Knudson FEF25Z 0 043H 0 025A 0 132 Knudson FEF50Z 0 035H 0 013A 0 444 Knudson FEF75Z 0 014A 3 042 Knudson FEF25 75 0 021H 0 24A 1 171 Knudson FEF75 85 0 06H 0 021A 0 321 Morris Height expressed in centimeters ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Appendix V Equipment Supplies and Vendors Replacement Equipment and Supplies The maintenance and supply kit provided with the S amp Pulmo Screen II system includes 1 S amp M Pulmo Screen II Instruction Manual 2 IBM PC manuals Guide to Operations BASIC Manual DOS Manual and Printer Manual 3 Collins one year warranty 4 Disposable mouthpieces 5 Disposable noseclips 6 Disposable recording pens 7 Kymograph chart paper with adhesive strip
12. 4 Pulmonary Function Assessment Version 2 0 October 1990 A 100 Vendors and Technical Advice Replacement equipment and supplies may be obtained from the companies listed below 1 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 2 0 October 1990 Appendix VI File The files should be formats given below without this manual Coordinating Center Columns 1 7 8 12 13 15 16 17
13. 4e ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 23 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 Expected Actual Deviation Position 1 57 57 0 Position 2 526 33 7 Position 3 995 996 1 Position 4 1464 1467 3 Position 5 1934 1937 3 Position 6 2403 2410 7 Position 7 2872 2879 7 Position 8 3341 3347 6 Position 9 3810 3810 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 S Press SPACE BAR to continue Figure 3b Linearity Results ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 24 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 2 0 October 1990 Page 25 SPIROMETER Figure 4d Attach Rudolph valve to the short tubing and the spirometer breathing tube SPIROMETER Figure 4e Attach the 3 liter syringe to the short tubing ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 26 6 Press SPACE BAR 7 OPEN the Rudolph valve turn clockwise then OPEN the syringe
14. 8 Metal leak tester weight Collins Cat 021525 9 3 liter calibrated syringe Rudolph Cat 5528 10 Rudolph one way valve with Stopcock Rudolph Cat 2150 Extra spirometry supplies which should be on hand are 1 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 o Oo 41 0v Ui LO P9 E o Cidex Vinegar Silicon spray lubricant Rubber stoppers size 7 Alcohol wipes Q tips 6 inch Smelling Salts power strip with grounded outlets circuit breaker pilot lights line voltage suppressor and master switch Allen wrench ARIC PROTOCOL
15. 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 2 0 October 1990 Page 68 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 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 l Unplug the spirometer power cord and disconnect the cable leading from l 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
16. 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 attach 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 2 0 October 199
17. calibration constant recorded on the diskette will be e 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 5 is acceptable If more than a 2 5 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 range 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 72 Br
18. 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 will 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 F6 for the Flow and Volume Calibration Checks This program will calibrate the spirometer to the 3 liter syringe and determine
19. 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 F8 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 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 22 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 4d 5 Attach the 3 liter syringe to the SHORT LENGTH OF TUBING Figure
20. on the MRP on off switch 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 A 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 2 0 October 1990 Page 17 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 weekly Daily Checks 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 nec ml drop per 2 rotations Accept leak up to 1
21. 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 the 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 2 0 October 1990 Page 69 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
22. 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 18 The Maximal Respiratory Pressure MRP transducer is a solid state analog device which converts positive and negative pressure differences into proportional electrical voltages This transducer is assembled by the S amp M Instrument Company with an aneroid pressure gauge which displays the measured pressures to 250 cm H 0 When connected to the modified S amp M A D interface installed for Visit 2 in expansion slot 1 of the PC XT the real time pressure time curves are displayed on the computer screen Supplies needed for conducting spirometry and maximal respiratory pressure include disposable mouthpieces disposable noseclips disposable red recording pens calibrated chart paper a calibrated 3 liter syringe disposable 5 cc syringes a Rudolph one way valve stopcock connecting tubing a thermometer a metal leak tester weight and a stopwatch Computer supplies should in
23. to BTPS PB PB 47 X 310 273 T 12 2 7 3 ATPD to ATPS PB PB PH20 12 2 8 BTPS Body Temperature 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 BIPS 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 273 T 273 12 2 0 3 STPD to ATPD 760 PB X 273 T 273 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 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 participa
24. 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 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 2 0 October 1990 FIELD CENTERS Page 74 Subject Enrollment Respiratory and smok ng 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 o
25. 0 Page 70 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 techniques Assessment of tracing acceptability and reproducibility Data management and transfer procedures Calculation of spirometric parameters NOU EWN 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 te
26. 0 ce Linearity Check Accept linearity Record slope up to 0 100 Record linearity Volume Check After connecting open 3 liter syringe Record volume From screen From chart paper Add 3 liters and record new volume From screen From chart paper Accept New Volume of 2 95 3 05 L Record baseline volume From screen From chart paper Weekly Checks Dates Volume Number MRP Calibration Current Previous Field Center Error Positive Archive Disk Negative Empty and dean spirometer Pulmonary Reading Ct Mailer Disk Version 8 12 89 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 18 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 top 8 liter lines should match wh
27. 1 222 227 ARIC PROTOCOL 4 Contents Status Code Blanks Number of pulmonary function tests done Status Code Acceptability code detail for second best test 0000000 acceptable O spirometer calibrated l spirometer not calibrated correctly 9 no flow volume loop stored for acceptability good start calculation l computer started after start of expiration 9 no flow volume loop stored for acceptability O no breath hold leak l breath hold leak gt 52 9 no flow volume loop stored for acceptability Ozmaximal effort l submaximal effort 2 borderline maximal effort 9 no flow volume loop stored for acceptability O no cough or inhalation l cough inhalation present 9 no flow volume loop stored for acceptability 0 plateau l no plateau 2 borderline plateau 9 no flow volume loop stored for acceptability O water level is adequate l low water level in spirometer 9 no flow volume loop stored for acceptability Status Code Blanks Spirometer Temperature Celsius Status Code Blanks calculation calculation calculation calculation calculation calculation of of of of of of of A 103 Pulmonary Function Assessment Version 2 0 October 1990 Columns 228 230 231 232 239 240 241 248 249 250 257 258 250 267 268 269 276 277 278 279 286 287 288 295 296 297 304 305 306 313 314 315 322 323 324 332 333 334 344 345 352 353
28. ATHEROSCLEROSIS RISK IN COMMUNITIES STUDY Manual 4 Pulmonary Function Assessment The National Heart Lung and Blood Institute of the National Institutes of Health ARIC PROTCOL Manual 4 Pulmonary Function Assessment Visit 2 Version 2 0 October 1990 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 4145 Version 2 0 October 2 1990 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 Ve
29. Function Reading Center ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 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 the 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
30. HER 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 10 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 gt type RANDOM ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 66 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 best 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 photocopy 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
31. OTSTA 6S St JF erBuv erneut ps 99P 0 TOA Jead x 8806 ETM 69SM HSVM lt 3 Pulmonary Function Assessment Version 2 0 October 1990 ARIC PROTOCOL 4 A 91 Weekly Report to Coordinating Center from Pulmonary Reading Center Batch number Date Record in batch 1 O on od wo AA t N 3 n3 n3 d e Lg pot e E n fous 23 File name E F377 DAT E F378 DAT E F379 DAT E F380 DAT E F381 DAT E F382 DAT E F383 DAT E F384 DAT E F385 DAT E F386 DAT E F387 DAT E F388 DAT E F389 DAT E F390 DAT E F391 DAT E F392 DAT E F393 DAT E F394 DAT E F395 DAT E F396 DAT E F397 DAT E F398 DAT E F399 DAT ARPZ0015 DAT 07 14 1987 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 App
32. 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 system S amp M 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 3 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 s
33. 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 2 0 October 1990 Page 61 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 M Instruments Pulmo Screen II system requires formatted floppy disks 9 2 1 To format a disk type the commands 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 1 The floppy disks will be labelled with the batch volume nu
34. alibration 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 4 77 84 FEV3 FEV6 99 Total Trials 5 Quality Code 1 Comments Computer Impression Sp IVoMeeny 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 25 DAT Spirometry Report ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 60 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 662 of predicted the report will identify type of impairment obstruction or restriction and recommend that the 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
35. als to a maximum of five trials recording on the spirometer chart paper the greatest inspiratory pressure observed on the aneroid gauge for each trial 9 Photocopy the tracings and mail the originals to the Pulmonary Reading gt 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 2 0 October 1990 Page 16 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 Collins Spirometer 5 Depress the white dot
36. aper speed Chest 1983 84 161 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 Black LF Hyatt RE Maximal static respiratory pressures Normal values and relationship to age and sex Am Rev Respir Dis 1969 99 696 702 Leech JA Ghezzo H Stevens D Becklake MR Respiratory pressures and function in young adults Am Rev Respir Dis 1983 128 17 23 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 ATS 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 vo
37. ary Function Assessment Version 2 0 October 1990 ARIC PROTOCOL 4 Page 49 BAT TR a LOW WATER LEVEL IN SPIRQE TER N39 0 m8 amp LERS 00 cy Cm L4 LITERG i CN Low Water Level Figure 19 Pulmonary Function Assessment Version 2 0 October 1990 ARIC PROTOCOL 4 Page 50 00 CU Q allel el Ee o E g 2 8 B B S d S s b ss i 9 ist ie sl i 1 e E JAS LW 6 TOT li TUTTI TN LLLA UIT T EELE UNSUSTAINED EFFORT ui Premature Termination No Plateau Figure 20 Pulmonary Function Assessment Version 2 0 October 1990 ARIC PROTOCOL 4 Page 51 Name SMITH JOHN Date 01 29 1987 Study ARIC Trial 6 Actual Fi sty B FVC Q 3 93 ae FEV 1 Q 3 53 FEV 1 FvC X 90 FEV 3 1 3 93 FEV 3 FVC 3 100 P EV 6 Q 3 93 FEV 3 FEV 6 X 100 FEF25 75 l s 4 63 4 PEFR V s 9 39 FEF25 V s 6 94 2 FEF50 Vs 5 01 FEV75 Vs 2 17 j 2 3 4 S Uol 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 2 0 October 1990 Page 52 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 5Z and the so
38. 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 performance Note Depending upon the participant s level of understanding a repeat demonstration may be required after each spirogram 8 4 Operation of the Flow Volume Loop Program l Change the mouthpiece 2 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 11 4 Have the participant breathe normally through his mouth while wearing noseclips ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 40 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
39. cceptable l not acceptable 9 unable to assess acceptability Status Code Time to best FVC seconds Status Code 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 Pulmonary Function Assessment Version 2 0 October 1990 Columns 507 508 509 510 512 213 514 518 514 515 516 517 518 519 520 524 525 526 527 528 529 ARIC PROTOCOL 4 A 106 Contents Status Code Reading Center Quality Code computer generated 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 9 unable to assess quality Status Code Pulmonary Technician Code Status Code Reasons for Test Postponement History of aneurysm or BP gt 200 120 yes 2 no O not asked History of MI or chest abdominal sur
40. centive display for feedback Reinstruct the participant to obtain even better results There is a considerable learning effect so participants need vigorous encouragement Tests lasting less than 1 second will not be saved The MIP is measured at the highest point on the curve after the first second Acceptable tests must last at least 2 seconds A minimum of 3 trials with a maximum of 5 trials should be done to get 2 reproducible curves the second best must be within 90Z or more of the best The best trial is always listed at the top righthand side of the incentive display Figure 24 At the conclusion of testing Press the ESC key to return to the MRP menu Then Press 4 Exit to Main Pulmonary Menu 8 6 1 Quality Criteria for the Maximal Respiratory Pressures Program maximal respiratory pressure is considered reproducible if the second best test is 90 or more of the first best test An acceptable quality is assigned if the tests last at least 2 seconds 8 7 Report Generation 8 7 1 Prepare the printer 1 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 Type the letters DAT or press the F4 function key to load the program The screen will display the prompt Prepare PRINTER then Press the SPACE BAR Set the paper in the printer so the first printed line will be just below the perforati
41. ch 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 l 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 exhaling 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 i 8 2 Positioning the Subject 1 Testing should be conducted in the standing position A chair should be positione
42. 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 calibration syringe Repair replace the syringe ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 29 Press SPACE BAR after third stroke Figure 6a Volume Calibration Check Screen 3 Figure 6b Volume Calibration Check Screen 4 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 30 Johns Hopkins University Instrument Calibration Check Last Calibration was 01 29 87 1 83 Liters 0 01 Liters Second Volume Flow 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 4 83 Liters 0 03 Liters Second Volume Flow Press SPACE BAR to Return to Menu Figure 7b Volume Calibration Check Screen 6 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 31 Any abnormally large number less than 20 00 liters sec or greater than 20 00 liters sec may indicate a problem with the flow channel of the S amp M Instrument Pulmo Screen A D interface
43. chive floppy disk for the week Files downloaded from hard disk to second mailer floppy weekly and then erased from hard 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 Function Assessment Version 2 0 October 1990 Page 76 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 a smooth continuous exhalation b apparent maximal effort c 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
44. cified above is indicated by using the Arrow Keys to select CONTINUE TEST Following selection of this alternative the program will bring up a screen asking whether the participant has had FLU BRONCHITIS OR PNEUMONIA IN 3 WKS 2 Y 1 N Enter CIGARETTE PIPE CIGAR IN LAST HR 2 Y 1 N Enter Enter a 2 for an affirmative response or a 1 for a negative response figure 10d Following selection of this alternative the program will return to the Pulmonary Program Menu Continue with Spirometry Testing Enter FVL or Press F2 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 37 ee ee ee a en ee ee ge UMAREE Select Reason for Test Fastponement i gt HISTORY GF ANEURYSM OR BP 200 120 HIST OF MI CHEST ABDOM OTHER SURG IN amp WES CONTINUE TEST Use Arrow keys to changes Selected gt HISTGRY OF ANEURYSM OR BF gt 200 120 Figure 10a Select reason for test postponement FLU BRONCHITIS PNEUMGNIA IN 3WES 2 Y 1 N Enter 1 CIGARETTE FIFE CIGAR IN LAST HR 2 Y 1 N Enter 1 Figure 10b Flu bronchitis pneumonia smoking ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 38 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 coa
45. clude very high grade double sided double density diskettes TDK Brown IBM Verbatim or Dysan brands are recommended and fan fold perforated printer paper Lists of replacement equipment supplies and vendors are in Appendix V ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 5 2 1 1 Hardware 1 Collins Survey II spirometer with potentiometer 2 speed kymograph and water drain Collins Cat 006038 2 S amp M Instrument Company maximal respiratory pressure transducer with aneroid pressue guage display 250 cm H0 3 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 4 IBM Color video display monitor with color graphics adapter board including clock calendar 5 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 2 0 October 1990 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
46. d 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 39 breathing efforts should be loosened Dentures if they are loose should be removed since they will prevent 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 3 Demonstration of Procedure l 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
47. d quality of test 3 compare pulmonary reading center s measurements with field centers measurements 4 compare pulmonary reading center s measurements 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 2 0 October 1990 Page 78 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 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 2 0 October 1990 Page 79 12 TERMS AND SYMBOLS 12 1 General 1 STPD Standard conditions temperature at 24C barometric pressure 760 mmHg 760 torr and dry 0 torr water vapor 2 BTPS Body conditions Body temperature usually 37C ambient barometric pressure and saturated with water vapor usually 47 torr water vapor at these conditions 3 ATPD Ambient temperature pressure and dry 4 ATPS Ambient temperature pressure and saturated wi
48. disk A listing of the contents of the mailer floppy disk 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 OWN 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 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 f
49. dots aud 2 at6uy OA Jead JAd T TA34J MOT 88d adors aug J ertBuy TOA 8a8d X OPGGETM cSGMNHSVMN 3 288 t peuoistAtp fF MO J Pulmonary Function Assessment Version 2 0 October 1990 ARIC PROTOCOL 4 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 Pulmonary Reading Center and Field Center PULMONARY CENTER FIELD CENTER DIFFERENCE FVC 3 35 3 35 0 00 FEV 2 55 2 52 1 18 Comparison of Measured Results to Computer Results MEASURED COMPUTER DIFFERENCE FVC 3 35 3 43 2 39 FEV 2 55 2 57 0 78 Differences 3 are acceptable ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 493T1 T UOTSTATD T E amp auntoA LLL LLL LLL LLL NE LA 9 0 SMO j xeed JTP X UT TTT TTT TTT TT TT NT A L LL LL LII LL tt NY TIS YA3J vaa nora aea Tt 2E OT aedors aJg wua ceuw 1 tt ion cee 6Ib E OAS one aa see eRe OL L MOTS Jead eszer saorsa Tt BS Z Zg arBuy saso r a aesae ot tt ooren S tL TT 96p 2 TASS woz nots weed ttt 2r St ado s add 208 U
50. eath hold leak gt 5 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 October 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 pu
51. eck that printer is on line If not re boot with CTRL ALT and DEL keys after turning 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 Failure of printer card 7 Fault light on printer on a No paper in printer b Printer internal failure Pulmonary Function Assessment Version 2 0 October 1990 B Troubleshooting Guide Software Problem Program disk does not load Screen displays the C gt character No disk will load S amp or other source Read error on video screen No volume and or flow when spirometry is performed l 3 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 Unacce
52. ed 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 102 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 d The listing of the 10 random sample of the participants for the week e The actual tracings 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 spiromet
53. ed 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 FEV4 to FVC expressed as a percent 6 FEF 25 75 Mean rate of flow expiratory measured between 25 and 75Z of the forced expiratory vital capacity ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 54 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 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 20 with a 12 adjustment for Blacks and Orientals 8 5 8 Data Defaults All FVL data selections are based on current American Thoracic Society recommendations The criteria are 1 FVC FEV Highest value is selected regardless of FEV rgV trial in which it occurred PEFR 2e FEV FVC Highest values of FEV FEV and FVC are FEV FVC selected regardless of trial 3 FEF25 75 75 85 From curve with highe
54. endix II Troubleshooting A 92 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 In 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 When computer is turned on no display on video monitor disk drive light off When computer is turned on no display on video monitor disk drive light comes on Keys pressed on keyboard are ignored after program is loaded Printer fails to print when command is given Funny characters printed instead of graphic or data display ARIC PROTOCOL 4 Cause Solution l Power cable not connected to monitor and or CPU 2 No power to IBM 3 No power to monitor green light off 4 Wall outlet power off 1 Monitor not turned on no power to monitor 2 Video cable not properly 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 1 Keyboard not properly connected or in need of repair 1 Execute printer command 2 Ch
55. er 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 15 l 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 other 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 Explain the MIP procedure position the participant and demonstrate the test as usual Conduct a minimum of three MIP tri
56. ere 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 time calibration should be done to insure that two rotations of the drum take 30 seconds 1 29 7 30 3 seconds l 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 F9 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 2 0 October 1990 Page 19 Spirometer Leakage Test Enter total time for leakage test defe 5 min
57. f spirogram tracings Data management Statistical quality control of group field center data Report 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 FC Transmittal to PRC Data receipt confirmation Age sex standing amp sitting height weight and selected smoking and respiratory questionnaire responses Data receipt confirm Return of floppy disk ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 75 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 Participant instruction Attach identifying label to paper tracing Spirometry testing l Real time monitoring of quality by computer software Technician quality evaluation Data Management Raw pulmonary records are stored on hard disk and on ar
58. ftware now checks for a 5 leak although the screen message still shows 102 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 5 2 Reproducibility A spirogram is considered reproducible if the second best FVC is within 52 of the best FVC and if the second best FEV is within 52 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 5 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 5 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 give
59. gery in past 6 weeks l2no yes O not asked Flu bronchitis or pneumonia within past 3 weeks Status Code Blanks Maximal Inspiratory Pressure CC MIP Status Code Reproducibility Code for MIP 0 reproducible l not reproducible Status Code Acceptability Code for MIP acceptable l not acceptable Status Code Pulmonary Function Assessment Version 2 0 October 1990 VI 10 11 12 A 107 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 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 Di
60. graph 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 that the leak was in the inter
61. h hold leak gt 5 of FVC 4 Submaximal effort rounded peak on FVL loop 5 Cough inhalation present 6 No plateau and tests not carried to 10 sec 7 Low water level in spirometer 9 Flow volume loop not stored Reading center and field center quality codes disagree Quality codes 1 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 9 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 lo l W561 Acceptability code s 4 Borderline 006 PARTICIPANT NAME W139973 07 09 1987 Yes 1 l W562 026 PARTICIPANT NAME W140071 07 09 1987 No 5 e 9 F l W563 Acceptability code s 5 031 ee NAME W140005 07 09 1987 Yes l l 031 PARTICIPANT NAME W140018 07 09 1987 Yes 1 1 W565 006 PARTICIPANT NAME W140188 07 10 1987 Yes 1 1 W566 031 ERT al NAME W140170 07 10 1987 Yes 1 1 031 cee NAME W140220 07 10 1987
62. he 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 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 MRP FA DAT FS CAL F6 ADJ F7 DIS F8 LIN F9 LEA A description of each program follows ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 9 re mre areolar r aa Fulmenary Program Menu EN INF Enter Fatient Information FYL Flow Volume Loop MRE Maximal Fespiratory Fressure DAT Patient Data Sheet i i H CoL Check Calibration ADJ Calibrate Flow amp Volume i DIS Disc Storage Programs LIN Linearity Check i H LEA Spirometer Leakage Check i ji l Enter FROGRAM you wish to Run Figure 1 P
63. he 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 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 2 0 October 1990 A 97 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 Morris PF 0 094H 0 035A 5 99 Knudson FEF25 0 088H 0 035A 5 618 Knudson FEF50 0
64. ily Spirometer Log The positve MEP and negative MIP pressures should both be within 52 of the previously saved results If the new calibration results are within 5Z of the previously saved results the computer considers the system to be within calibration and the previous calibration values are preserved Press the spacebar to return to the MRP menu If either the positive or negative MRP calibrations are out of range gt 52 error you should press Y Yes when asked whether to store the new calibration constants You should then repeat the MRP calibration steps 2 7 above to confirm that the calibration remains within 5 Press N if you wish to discard the new MRP calibration results for some reason ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 32 Calibrate Fressure Transducer Calibration Data Fressure Intercept Binary Slope New Frevicus Date 11 27 1990 11 14 1990 Time 08 14 19 14 50 26 Fasitive Fressure Intercept 195 178 Fositive Fressure Slope 11 10 Fositive Error Actual Expected 0 58 Negative Fressure Intercept 2899 equ Negative Fressure Slope 11 11 Negative Error Actual Expected 1 04 Press SFACE BAR TO CONTINUE Figure 8a Calibrate Pressure Transducer Calibrate Fressure Transducer 7 Remove mouthpiece tube and attach Scc syringe Pressure 4 cmHed Adjust pressure gauge to zero with syringe press SPACE BAR when set te zero Figure 8b Calib
65. in drive A b Type A UPLOAD press ENTER 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 1 from drive A d Insert S amp disk 2 in drive A e Type A UPLOAD press ENTER Remove disk 2 from drive A g Store disks 1 and 2 in a safe place h Type GO press ENTER i Type INI j Press Ctrl Alt Del keys simultaneously The screen 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 2 0 October 1990 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 t
66. ith 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 after 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 9 Spirometry is the simplest most effective and least expensive test for assessment of pulmonary function 10 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 pro
67. lation 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 2 0 October 1990 Page 45 H A j A Bl iS S Ri Si Bi gi R EERI ae d di a R y JUIN iil ill B id 1 EHE dub DUO TET 5 5 dg EE 3 F t 53 Eg Study ARIC 75 a Name SMITH JOHN Date 01 29 1987 Trial 43 FEV 3 FEV 6 FEF25 FEF 25 FEFSO FEV75 PEFR Leakage is over 10 of FVC Press SPACE BAR for FYL er ESC for Pulmonary Menu 5401 4 FVL Screen showing leakage over 10 FVC Leakage over 5 of FVC 3 x t1 Pulmonary Function Assessment Version 2 0 October 1990 Fia 4 Figure 14 Figure 15 10 ARIC PROTOCOL 4 Page 46 Flow 4 division 1 sec a Oe a ee OH 0 OO ee ESTETAENAE FO a Ae ACCC A ASNSEREREAN WA LCELELCEELLL CCLLLECLLLELE POC A i Os ANT ENRERE ERT Volume 4 divisione liter Figure 16 Submaximal Effort ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 47 Flow 4 divisione4i 1 sec J POC eee ELN LED a LI Volume 4 division 4i liter Figure 17 Obstruction of Mouthpiece ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 48 TT AN n Il COUGHING II JT Cough Figure 18 Pulmon
68. lect the default option 2 AUTO SCALE FVL On l 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 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 2 0 October 1990 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 1 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 24 C ITOH Color Blue DS four color ribbon printing data sheet in blue only s 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
69. lmonary 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 Progress 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 2 0 October 1990 Page 73 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 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
70. lume 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 27 31 32 33 34 35 36 children and adolescents age 5 through 18 years Am Rev Resp Dis 7 1971 104 680 687 37 A 109 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 effects of age Am Rev Resp Dis 1976 113 587 600 Cotes JE Lung Function 2nd Ed FA Davis Philadelphia 1968 1978 Schmidt CD Dickman ML Gardner RM Brough FK Spirometric standards for heal
71. lumns 142 156 157 161 162 163 164 165 166 171 172 176 177 178 182 183 184 188 189 190 196 190 191 192 193 194 195 196 A 102 Contents Blanks Height inches Status Code l 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 spirometer calibrated l spirometer not calibrated correctly 9 no flow volume loop stored for calculation of acceptability good start l computer started after start of expiration 9 no flow volume loop stored for calculation of acceptability O no breath hold leak l breath hold leak gt 5 9 no flow volume loop stored for calculation of acceptability O maximal effort l submaximal effort 2 borderline maximal effort 9 no flow volume loop stored for calculation of acceptability O no cough or inhalation 1 cough inhalation present 9 no flow volume loop stored for calculation of acceptability O plateau l no plateau 2 borderline plateau l 9 no flow volume loop stored for calculation of acceptability O water level is adequate l low water level in spirometer 9 no flow volume loop stored for calculation of acceptability ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Columns 197 198 202 203 204 205 206 212 206 207 209 210 211 212 213 214 216 217 220 22
72. mber 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 2 0 October 1990 2 Note Page 62 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 34 When the format is complete there will be a prompt for entering a volume number for the diskette Enter 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 di
73. monary Function Assessment Version 2 0 October 1990 Page 65 Participant Directory Ordered by ID Numbers ID Numbers Names Date F121121 HEYER ROB 12 17 85 F122341 GLAZE DONNA 12 17 85 J100123 FARIS DONNA 12 18 85 J111112 ARNOLD GEORGE 12 18 85 M156575 CLOSE ANDREW 10 03 85 W162424 JORDAN DOROTHY 12 13 85 W191219 HART JOHN 12 13 85 W200001 ROSS JOHN 12 01 88 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 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 OT
74. muscular disorders respiratory muscle weakness leads to decreases in the Maximal Inspiratory Pressure MIP and FVC and possibly to a reduced ability to withstand the stress of cardiovascular disease Measurement of maximal respiratory pressures is a quick and easy way to determine the strength of the respiratory muscles The diaphragm is the major muscle of inspiration Assisted by the intercostal and scalene muscles which lift the ribs up and out the descending diaphragm creates a negative pressure inside the chest which drives air into the lungs inspiration The original techniques for measurement of maximal respiratory pressures described by Black and Hyatt 16 have been modified 17 The Maximal Inspiratory Pressure MIP is most easily measured at the mouth following a near maximal expiration to low lung volume near residual volume Normal values for this test are not well established although on average men are expected to produce a MIP of 100 cm H 0 and women are expected to produce a MIP of 70 cm H 0 with some decline expected with increasing age Quality control criteria for this test have been programmed into the ARIC pulmonary function programs for Visit 2 to assist the technician in guiding the participant through the MIP maneuver The results will be automatically incorporated into both the printed spirometry report and into the electronically stored record 1 2 Description of the Pulmonary Function Measurement System
75. n an overall quality code by the technician according to the following criteria ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 53 Table 1 Quality Codes for Spirograms a me a meeen e me e a a re eg anaana annn SSS SSS eee eS SS SS SSS SS SS SS SSS a SS SSS 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 5 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 5 6 End of 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 5 7 Definitions of Flow Volume Loop Parameters all Volumes Corrected to BTPS 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 expir
76. nal tube If however the reading does go down then the leak is in the spirometer bell ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 21 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 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 Press the SPACE BAR to go directly to the Linearity Check To return to the Pulmonary Program Menu press ESC 6 7 Linearity Check
77. nformation Before Beginning Procedure eee S8 4 2 Main Pulmonary Menu Description CREW A E LE UA RUE eR 8 5 Protocol Summary eee een nn Vs dece ele diei e ee Oe A 12 5 1 Daily Procedures eee eee nnn ace ee PTT 12 5 2 Weekly Procedures wwe e eile p ee bra b RR ce is eoe ere ol er eee LE 5 3 Manual Back up Procedures for Recording Raw Pulmonary Function Data d x xp RR XURERE ep Rk eae es ohio a E EE RV bee ee sete 6 Instrument Preparation and Calibration eee nnn 16 6 1 Power up the Computer eee eee ALEE lier eno iene PPM REIR UR 16 6 2 Water Level Temperat ure oc ev v ve e xor d esee sse l0 6 3 Spirometer Hose eee eee mn eae e EEEE eis ai 16 6 4 Pen Check ecc 9299 9 9 99060996 092 69 9929692284999290269990600 99 29929282292998520929292929 92928 29 l0 6 5 Chart Paper and Baseline Checks cce eee eee eee nn n nns 18 0 6 Time and Leak CheckS 4 4 0 a e vad exp Raus esee rese LO 6 7 Linearity Check lov Sie Wie wince a rdce erg e RR RSS ER S ES SS 21 6 8 Volume Calibration Check ose kir Ra es t ka Vr ENTER ee te ees 26 6 9 Maximal Respiratory Pressure Transducer Calibration Check 31 7 Participant Information ls ga pu eee obs 6868 see SE vetas v2 7 1 Entering Information on Computer eee eee eene PC E J42 Editing l fort atio n i 4 i xr ERI A aes RECON AWO EAR V S RD 7 3 Postponement of the Test
78. nts whose processed records were included on floppy disk 2 Copy of field center report as noted above except 2 Electronic Evaluation of Acceptability and Quality field center Washington Co MD Date 07 17 1987 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 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 weekly Daily 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 per 2 rotations ___ Accept 29 7 30 3 seconds Cad nec 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 From chart paper Add 3 liters and record new volume From screen From chart paper Accept New Volume of 2 95 3 05 L Record baseline volume From screen B Weekly Checks Dates Volume Number MRP Calibration Current Field Center Error Positive Archive Disk Empty and clean spirometer Pulmonary Reading Ct Mailer Disk Version 8 12 89 ARIC PROTOCOL 4 Pulmona
79. o 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 122 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 34 Patient Information New Data Date 01 29 87 Time 09 40 Name SMITH JOHN ID Number W101234 Technician 031 Age 56 Sex M Height 160 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 9 INF Screen ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 35 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 position which needs correc
80. oducible ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 42 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 13b 11 WHEN PARTICIPANT TESTING IS COMPLETED PRESS ESC At this point the technician is required to enter an overall quality code Figure 13c 8 5 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 spirograms 8 5 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 5 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 Spirometer not calibrated correctly Computer started after start of expi
81. oducible within 5 The computer can assist this decision in the following ways a The computer screen Figure 12 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 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 13a F1 F3 Fl F2 and F3 may then be used to alternately remove and or l 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 t FVC American Thoracic Society ATS criteria ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 41 Press SPACE BAR to start FVL test Figure 11 FVL Screen 1 Name SMITH JOHN Flew LA B Date 01 29 87 Study ARIC is Trial 5 Actual l FVC 0 5 47 e FEV 1 1 3 8 FEV 1 FVC X n 8 FEV 3 1 4 96 FEV 3 FVC X 91 FEV 6 1 5 4 FEV 3 FEV 6 X 91 FEF25 75 1 s 4 83 PEFR Ys 11 29 us 2 1 E 123245 6 Mol rts Vs 2 13 2 of 5 spirograms are reproducible Press ESC key to end Figure 12 FVL Screen at end of test indicating two IUC s are repr
82. ollowing 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 2 0 October 1990 Page 67 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 whether 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
83. on 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 8 7 2 Page 56 Comments After the printer is prepared for final report press ENTER or use above options to enter comments The prompt will be 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 25 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 20 The following are the criteria for restriction and obstruction 1 Mild restriction FVCZ of predicted is less than 80 and greater than or equal to 66Z 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 ra
84. on 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 Enter the volume displayed on the screen and the volume 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 50 ml sec when spirometer is still 15 Enter the Baseline volume displayed on the screen and the volume from the kymograph
85. ptable Spirometry Technique Illustrations Reading Center criteria ARIC PROTOCOL 4 See See See See See See See See See See See Cause Solution Section 6 2 Section 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 45 51 Section 11 4 Pulmonary Function Assessment Version 2 0 October 1990 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 1 Volume Output only 2 Auto Scale FVL On 3 Information Enter Race 4 Color 5 Expired Only 6 Normal INF 8 Participant Data Storage on Drive C 9 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 ENTER TO CHANGE ENTER TO END In the following the default selections are indicated by 1 SPIROMETERS l 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 se
86. rate Pressure Transducer ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 aniano itta M a M s 4 M M ee at Page 33 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 9 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 folder is correct 4 ID NUMBER participant identification number The contact year should be entered after the ID number by typing a dash then the two digit contact year number 04 for example 5 TECHNICIAN S CODE the last entered technician code will appear The technician code consists of a unique three digit numeric code assigned t
87. ration 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 0 Ul RB CON I 8 5 1 2 Location of Typical Errors During Forced Expiration Each of these errors has a most common location either at the beginning middle or end of expiration ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 43 ux Trial 4 1 Actua 8 FVC 5 43 FEV 1 1 4 70 FEF25 75 1 S 5 70 6 PEFR Vs 11 15 4 Trial 2 Actual FVC 0 3 76 2 FEV 1 0 3 31 FEF25 75 1 S 4 48 PEFR Vs 8 67 1 2 3 4 5o Press SPACE BAR for FVL or ESC for Pulmonary Menu Figure 13a FVL Screen obtained by pressing F9 Wame SMITH JOHN W101234 Tria FYC FEV 1 Date 01 29 87 Prebronchodi lator 1 5 43 4 70 to C1 2 3 76 3 31 e YW 50 Oc OO 12345678 9 101112 1314 15 16 7 18 19 20 Press SPACE BAR to CONTINUE Figure 13b 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 13c FVL Screen for entering quality code ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 44 Error Location Acceptability Code 1 BEGINNING of a forced e
88. rm this selection by observing the volume time spirograms produced directly by the Collins spirometer Following the Flow Volume Loop FVL procedures for obtaining acceptable and reproducible spirometry unchanged from Visit 1 the Visit 2 participant will be instructed in the procedures for obtaining at least three acceptable of 2 or more seconds duration MIP efforts the best two of which must be reproducible within 10 The computer will assist this determination by displaying all maneuvers graphed as inspired pressure time curves The maximum inspiratory pressure is recorded after the first second of each maneuver and is displayed along with the percentage of the best effort 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 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
89. rn to the Pulmonary Program Menu Type STO to store this information into the computer No Data sheet will be printed for this participant 7 3 2 Recent Myocardial Infarction or Chest Abdominal Other Surgery Individuals who have a history of a Myocardial Infarction MI Heart Attack or Surgery of the Chest or Abdomen within 6 weeks are advised to return for spirometry after 6 weeks to allow completion of the healing process The presence of either of these conditions is indicated by using the Arrow Keys to select HISTORY OF MI CHEST ABDOM SURGERY IN 6 WKS figure 10a Then PRESS ENTER ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 36 Following selection of the appropriate alternative the program will bring up a screen asking whether the participant has had FLU BRONCHITIS OR PNEUMONIA IN 3 WKS 2 Y 1 N Enter Enter a 2 for an affirmative response or a l for a negative response Figure 10b Following selection of the appropriate alternative the program will return to the Pulmonary Program Menu Print a Patient Data Sheet Enter DAT or Press FA If reasons for postponement exist please terminate and reschedule the testing session Indicate the reason for test postponement in the comments section of the Data Sheet When retesting a participant enter R instead of the field center letter before the ID number 7 3 3 No Reason for Postponement Continue Test The absence of the conditions spe
90. rsion 1 0 Subsequent modifications of Version 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 2 0 October 1990 iii Pulmonary Function Assessment 1 Introduction eel ee eee een tnn rer 1 1 The Importance of Pulmonary Function Testing in ARIC l 1 2 Description of the Pulmonary Function System lees 2 2 Pulmonary Equipment ccc rece cc cece c erect e eee hh rr ttn 4 2 1 Description cccccccccccvcccccncccccccerecnccesessessseessaeenoes 4 3 Installation cc eee eee ee CUT 6 4 Computer Software eere reece TUMOR EDDA 4 1 General I
91. rticipants 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 IDf 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 2 0 October 1990 Page 64 Disc Storage Programs 1 Patient Directory Review Patient Data 2 Print Patient Directory Print Patient Directory from floppy 6 7 3 Story Patient Data 8 Copy data from floppy to hard disk 4 Switch Names Id Names 9 Exit to Pulmonary Program 5 Copy stored data to floppy 14 Enter your Selection __ Patient Name SMITH JOHN ID W101234 Date 01 29 1987 Figure 26 DIS Disk Storage Program Menu ARIC PROTOCOL 4 Pul
92. ry Function Assessment Version 2 0 October 1990 Patient Directory Ordered by Names in Drive C Om am am am oe am a om ee ee ee ee ee ee ae oe w 5 m C 40 20 2 70 O zm Xr x cV ocwnmmeu o0 o ID Numbers acu am GE Gus qe REUS QUAM ee que GE qu GU KR em Oe pns Oe Om QA Oe ee te diem AUS QNS ues qe quu ame Ae Rn UP OD ED ADOS uum Gia qe ume at 1138737 Wi3B00S5 138694 W137923 W137891 W106354 W128450 W188559 W135178 W138071 W138060 W138106 W138119 W137996 W137935 W138480 W138534 W138529 W138590 W138633 W138495 A 83 07 02 87 06 29 87 07 02 87 06 29 87 06 29 87 06 29 87 07 01 87 07 01 87 07 02 87 06 39 87 06 30 B7 06 30 87 06 30 67 06 29 87 06 29 87 07 01 87 07 01 87 07 01 87 07 02 87 07 02 87 07 01 87 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Tracings to be read for the week ending 02 17 88 Please read the tracings from the 3 best tests for each of the participants who are listed below the week ending 02 17 88 Ui kPWNe LI 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
93. s 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 Tockman MS Comstock GW Respiratory risk factors and mortality Longitudinal studies in Washington County Maryland Am Rev Respir Dis 1989 140 S56 S63 Ostler DV Gardner RM Crapo RO A computer system for analysis and transmission of spirometry waveforms using volume senpling 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 13 14 15 16 17 18 19 20 21 22 23 24 25 26 A 108 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 p
94. s 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 13 Following the experience of Ferris et al 19 the 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 The technician enters an overall quality code for the acceptable tracings at the completion of testing 5 1 4 Participant Maximal Inspiratory Pressure Testing Perform the MIP test on each participant Prior to testing explain that This test will measure the strength of your chest muscles Seat the participant facing the computer screen change the mouthpiece and demonstrate the MIP procedure Change the mouthpiece coach the participant to blow all his her air out to residual volume insert the mouthpiece and draw in air as forcefully as possible from the MIP device Coach the participant during the inspiratory effort Testing can be
95. sks will receive an even number 9 2 3 Type GO to Return to the Pulmonary Menu screen 9 3 1 Z 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 2 0 October 1990 Page 63 9 4 Data Storage Procedures Weekly 9 4 1 Operation of the Disk Storage Program 1 Type DIS or F7 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 will be displayed as in Figure 26 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 pa
96. st sum of FVC and FEV FEF25 FEF50 FEF75 4 FVL graph Graph selected from curve with highest sum of FVC and FEV 8 6 Operation of the Maximal Respiratory Pressures Program 1 Attach a new white cardboard mouthpiece to the MRP device 2 Type MRP or Press the F3 key from the Pulmonary Program Menu The screen will display the Maximal Respiratory Pressure menu Figure 22 3 Press 1 to select the Maximal Inspiratory Pressure test from the Maximal Respiratory Pressue Menu The screen will show the MIP incentive display Figure 23 4 Explain that This test will measure the strength of your chest muscles 5 Describe the technique as like trying to such a thick chocolate malt through a narrow straw Instruct the participant to exhale completely then inhale with as much force as possible 6 Demonstrate the MIP test using a spare mouthpiece 7 Seat the participant comfortably before the screen and attach noseclips ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 10 11 12 Page 55 Coach the participant to slowly expire all his her air out until his her lungs are empty Residual Volume RV When the participant reaches RV instruct the participant to insert the mouthpiece and PRESS THE SPACE BAR Then coach the participant during the performance of the maximal inspiration MIP effort by saying IN IN IN MORE MORE DEEPER During this procedure the participant should watch the in
97. start excessive variability between the three acceptable curves Hand measure paper tracings of randomly selected 10 sample management 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 number of acceptable records and percent of total ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 77 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 l identify tracing date technician participant 2 comments on technician s measurements an
98. stopped after a minimum of three trials which last at least two seconds At two reproducible within 10 maneuvers should have been performed The participant should be allowed a maximum five trials to produce the two reproducible tests 5 1 5 Data Management 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 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 14 5 2 Weekly Procedures 1 Print a listing of the contents of the hard disk and the archive floppy 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 complet
99. sts 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 1 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 2 0 October 1990 Page 71 3 A copy of the DAILY SPIROMETER LOG for the week 4 The listing of the 10 random sample of participants for the week 34 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 11 4 Data Management Procedures at the Pulmonary Function Reading Center Upon receiving the packages the Pulmonary Function Reading Center will do the following 1 Verify the contents of the diskettes by comparing ID s from the listing with the pulmonary function diskette files 2 Examine the Daily Spirometer Log sheets Compare volume number on Daily 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 3 Process the diskette files to check the quality of the forced expiration a The volume
100. 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 On the first day of participant testing for the week eg Monday run the MRP calibration after the spirometer calibration procedures 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 For each participant determine if either of the following reasons exist for test postponement l History of Aneurysm or BP gt 200 120 2 History of MI other surgery in 6 weeks If neither reason for test postponement exists continue test determining if either of the following is present l Flu Bronchitis Pneumonia in 3 weeks 2 Cigarette Pipe Cigar in last hour 5 1 3 Participant Spirometry Testing Perform pulmonary function test
101. th water vapor 5 BP Barometric pressure usually in mmHg or torr 6 C Degrees Centigrade 7 F Degrees Fahrenheit 8 1 liters 12 2 Equations 12 2 1 BTPS Correction Factors Factor to Convert When Gas Temperature Vol to 37C Sat Centigrade 1 112 18 1 107 19 1 102 20 1 096 21 1 091 22 1 085 23 1 080 24 1 074 25 1 069 26 1 063 27 1 057 28 1 051 29 12 2 2 Arm Span Factors for Participants with Severe Spinal Deformities Correction for Height Male Ht Black Males Ht Female Ht Arm Span 1 03 Arm Span 1 06 rm Span 1 01 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 80 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 BIPS 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 273 273 T 12 2 7 2 ATPD
102. 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 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 27 Johns Hopkins University 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 2 0 October 1990 Page 28 5 5 Figure 5b will appear on the screen Press SPACE BAR 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 calibrati
103. thy elderly men and women Am Rev Resp Dis 1973 108 933 939 Gaensler EA and Wright GW Are Envir Hlth 1966 12 146 189 Altman PL Dittmer DS eds Respiration and Circulation Biological handbooks Bethesda Maryland Fed of American Societies for Experimental Biology 1971 126 Morris AH Kanner RE et al eds Clinical Pulmonary Function Testing lst and 2nd edition Salt Lake City Intermountain Thoracic Society 1975 Dickman ML Schmidt CD Gardner RM Spirometric standards for normal Gaensler EA Evaluation of respiratory impairment Arch Envirn Hlth 1966 12 146 189 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990
104. ting 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 Center and the predicted values will be changed on the computer file 7 3 Postponement of the Test Following the Patient Information Screen the Visit 2 Pulmonary Technician will be requested to Select Reason for Test Postponement figures 10a through 10d 7 3 1 Untreated Aneurysm or Hypertension 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 two conditions aneurysm and poorly controlled hypertension systolic gt 200 diastolic gt 120 make it unwise to perform spirometry The participant s blood pressure will be found on the Itinerary sheet on the front of the chart The presence of either of these untreated conditions is indicated by using the Arrow Keys to select HISTORY OF ANEURYSM OR BP gt 200 120 figure 10a Then PRESS ENTER Following selection of this alternative the program will retu
105. tio 2 702 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 greater than or equal to 612 5 Moderate obstruction the ratio of FEV to FVC is less than 60 and greater than or equal to 45 6 Severe obstruction the ratio of FEV to FVC is less than 452 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 57 Maximal Respiratery Fressures 1 Maximal Inspiratory Pressure 2 Maximal Eupiratory Pressure 3 Calibrate Fressure Transducer 4 Exit to Main Pulmonary Menu Enter your selectian Figure 22 Maximal Respiratory Pressures ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 58 Name BENSEN JEANNETTE ID0st F123456 Date 11 27 1938 HIP Test 1 Instruct patient to expire to RU then perform MIP effort Figure 23 MRP Incentive Screen Name BENSEN JEANNETTE IDs F123456 Date 11 27 1938 MHIP Test 1 Instruct patient to expire to RU then perform MIP effort Figure 24 MRP Incentive Screen ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 59 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 c
106. ulmonary Program Menu ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 10 4 2 1 INF Participant Information This program is for entering participant anthropometrics which are used to calculate predicted values For Visit 2 the INF program has been modified to record reasons for test postponement It is essential that this program be run before performing any on line tests on a participant 4 2 2 FVL 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 MRP Maximal Respiratory Pressure This program measures the Maximal Inspiratory Pressure MIP and Maximal Expiratory Pressure MEP although only the MIP will be tested during Visit 2 Real time pressure time curves are displayed on the video screen along with percent of best effort to assist quality control 4 2 4 DAT Participant Data Sheet Selection of this program at the 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 5 CAL Calibration Check This program will verify the calibration of the system and decide if an adjustment ADJ needs to be run 4 2 6 ADJ Calibration Adjustment This program will adjust electronic
107. 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 unit 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 MRP Cable b Slot 2 Spirometer Cable c Slot 3 free d Slot 4 Video Monitor e Slot 5 Printer Cable Connect all power lines to the grounded AC power strip or other grounded outlets A minimum of five 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 2 0 October 1990 Page 7 10 To install the S amp M software on the hard disk do the following a Insert S amp disk 1
108. vide additional information about deviations from normal empyting of the lung Most of our information regarding normal pulmonary function comes from cross sectional surveys 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 11 the Snowbird workshop on standardization of spirometry 12 and further evaluations of commercially available spirometers 13 have indicated the importance of using a volume displacement spirometer the type of spirometer to be used by ARIC Both the Epidemiology Standardization Project 11 and the American Thoracic Society 12 have issued statements which provide criteria for spirometry test performance and for manual measurement However manual measurements are tedious and prone to error 14 Also deviations in test performance and lack of regular leak checking and calibration can result in loss of study data 15 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 10 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 2 Weakness of the respiratory muscles may play a role in the association of impaired spirometry with cardiovascular mortality Perhaps due to aging malnutrition or neuro
109. 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 7 DIS Disk Storage This program will allow the operator to conduct the weekly data storage procedures including display and printing of participant director es and transfer of data from hard disk to floppy mailer disk 4 2 8 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 ARIC PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 11 4 2 9 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 PROTOCOL 4 Pulmonary Function Assessment Version 2 0 October 1990 Page 12 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
110. xpiration 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 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 5 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 extrapo
111. yringe 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 Calibration of the maximal respiratory pressure MRP transducer will be done each week 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 into 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 The duration of the forced expiration will displayed on the screen A message will be displayed when at least two out of three maneuvers are reproducible FVC s within 5X During a minimum of 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 confi

ARIC Manual 4

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