Protocol - Spirometry - Adult
A spirometric test requires that the subject take a full, deep breath and then exhale as forcefully as possible into a handheld portable spirometer for several seconds. The subjects effort is called the forced expiratory maneuver and most commonly measures the amount and speed of air that is exhaled. The total amount (volume) of air exhaled is called the forced vital capacity (FVC). The amount of air exhaled in the first second is called the forced expiratory volume in 1 second (FEV1). Although handheld spirometers are commonly used in clinical research studies, the same results can be obtained from more-sophisticated floor-mounted devices, which are typically available in a respiratory function testing laboratory.
Numerous instructions are embedded in the protocol and in Table 1 of the protocol. This protocol is mainly for adults. The Spirometry - Preschool and Child protocol uses animated computer software and visual cues, which are necessary for young children.
The Sickle Cell Disease Curative Therapy Working Group recommends that this protocol be performed in transplant patients at one time point pre-transplant (baseline) and 100 days, six months, and annually post-hematopoietic cell transplant (HCT). The Working Group notes that a reduction in forced expiratory volume in 1 second (FEV1) can be caused by chronic graft versus host disease (GvHD) of the lungs.
The following description summarizes some of the key points. For the full protocol, see Miller et al., 2005.
Spirometers usually come with computer software. The spirometer must be connected to a computer during the spirometry tests. Provide subjects with a mouthpiece and a noseclip. Use of a noseclip is highly recommended but not mandatory. Allow subjects to put the mouthpiece in their mouth and blow with the noseclip attached to their nose. Record whether the noseclip was used.
To calibrate the spirometer, attach the device to a 3 liter syringe. Attach the spirometer to a computer and open the spirometry software to calibrate the spirometer. This calibration will measure the flow rate of the spirometer. Conduct three tests with the syringe and ensure that each result is ± 3% of the other tests. This is called a calibration check. Similarly, the syringe must also be calibrated; generally, the syringe flow rate results should be ± 0.5% of the other tests. Perform quality control tests on a weekly basis (see the manufacturer recommendations) and record the results in a log.
Provide a brief explanation of the spirometry test. Do multiple demonstrations of the spirometry test for each subject. Allow subjects to do practice attempts by putting their mouths on the spirometer, inhaling fully, and exhaling as forcefully as possible until no more air can be expelled. It may be useful to refer to the exhalation as a “blast” to ensure subjects exhale as forcefully as possible.
The subject should be sitting in a chair. Record the position (sitting or standing).
After the subject blows into the spirometer, the technician determines whether the attempt was a successful “maneuver.” An adequate spirometry test requires a minimum of three acceptable maneuvers (see the full protocol for more details about successful maneuvers).
Record the following results.
- Forced Vital Capacity (FVC)
- Forced Expiratory Volume in 0.5 seconds (FEV.5)
- Forced Expiratory Volume in 0.75 seconds (FEV.75)
- Forced Expiratory Volume in 1 second (FEV1)
- Repeatability of parameters above (see repeatability maneuver criteria in full protocol)
- Number of satisfactory attempts (maneuvers)
- Posture (sitting/standing)
Nose clips (yes/no)
Personnel and Training Required
Technician trained in conducting Pulmonary Function Tests (PFTs) with a spirometer
The primary instrument used in pulmonary function testing is the spirometer.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Spirometry is invaluable as a screening test of general respiratory health. This protocol is the international standard supported by both the American Thoracic Society and the European Respiratory Society. The selected protocol is well-established over many years and serves as the unambiguous standard for lung function assessment in clinical research studies.
|caDSR Common Data Elements (CDE)||Person Pulmonary Function Test Measurement Text||2970229||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Resp spirometry proto||62639-0||LOINC|
Process and Review
Expert Review Panel #6 (ERP 6) reviewed the measures in the Respiratory domain.
Guidance from the ERP 6 includes the following:
• No significant changes to measure
Back-compatible: no changes to the Data Dictionary
Previous version in Toolkit archive (link)
Protocol Name from Source
Miller, M. R., et al, Standardization of spirometry. Series “ATS/ERS task force: Standardization of lung function testing.”, EUR RESPIR J, 2005
Miller, M. R., Hankinson, J., Brusasco, V., Burgos, F., Casaburi, R., Coates, A., . . . Wanger, J. (2005). Standardisation of spirometry. Series “ATS/ERS task force: Standardisation of lung function testing.” European Respiratory Journal, 26(2), 330-331.
Andreeva, E., Pokhaznikova, M., Lebedev, A., Moiseeva, I., Kozlov, A., Kuznetsova, O., & Degryse, J. (2015). The RESPECT study: RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related etiology: a study protocol. BMC Public Health, 15(1), 831.
Berntsen, S., Stølevik, S. B., Mowinckel, P., Nystad, W., & Stensrud, T. (2016). Lung function monitoring; A randomized agreement study. Open Respiratory Medicine Journal, 10, 51-57.
Centers for Disease Control and Prevention (CDC). National Health and Nutrition Examination Survey (NHANES) 2007-2008. Respiratory Health Spirometry Procedures Manual.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX091601640000||Blank 1 or FEF25%||N/A|
|PX091601650000||Blank 2 or FEF50%||N/A|
|PX091601660000||Blank 3 or FEF75%||N/A|
|PX091601670000||Blank 4 or FEF90%||N/A|
|PX091601050000||Temperature (ºC) used in BTPS calculation||N/A|
|PX091601140000||Computer quality code||N/A|
|PX091601410000||Date of birth||N/A|
|PX091601170000||Date of review||N/A|
|PX091601080000||FEV1 quality attribute||N/A|
|PX091601750000||Flow data points (mL/s; variable number more||N/A|
|PX091601550000||Forced expiratory time||N/A|
|PX091601070000||FVC quality attribute||N/A|
|PX091601740000||Number of data points||N/A|
|PX091601630000||Original sampling interval||N/A|
|PX091601400000||Race (2-character race code)||N/A|
|PX091601430000||Reference values correction factor||N/A|
|PX091601420000||Reference values source (first author more||Variable Mapping|
|PX091601060000||Relative humidity (%)||N/A|
|PX091601200300||Spirometer serial number||N/A|
|PX091601130000||Technician quality control code||N/A|
|PX091601220000||Testing facility name||N/A|
|PX091601560000||Time to PEF||N/A|
January 29, 2010
Spirometry is a common pulmonary function test (PFT) measuring the amount (volume) and/or speed (flow) of air being inhaled and exhaled.
Spirometry is a tool used to screen for the presence of obstructive and restrictive lung diseases.
Respiratory, pulmonary function test, PFT, American Thoracic Society, ATS, European Respiratory Society, ERS, forced vital capacity, FVC, forced expiratory volume, FEV
|Protocol ID||Protocol Name|
|91601||Spirometry - Adult|
|91602||Spirometry - Child|
There are no publications listed for this protocol.