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Protocol - Spirometry - Adult

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Description

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.

Specific Instructions

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.

Availability

Available

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Protocol

The following description summarizes some of the key points. For the full protocol, see Miller et al., 2005.

Equipment

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.

Quality control

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.

Demonstration

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.

Setting

The subject should be sitting in a chair. Record the position (sitting or standing).

Successful maneuvers

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).

Recorded results

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

Equipment Needs

The primary instrument used in pulmonary function testing is the spirometer.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training Yes
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Physical Examination

Lifestage

Adolescent, Adult

Participants

Adults

Selection Rationale

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.

Language

Chinese, English

Standards
StandardNameIDSource
Logical Observation Identifiers Names and Codes (LOINC) Resp spirometry proto 62639-0 LOINC
caDSR Form PhenX PX091601 - Spirometry 5970262 caDSR Form
Derived Variables

None

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

Source

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.

General References

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.

Protocol ID

91601

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX091601_Acceptable_Maneuver
PX091601120000 Acceptable manoeuvre Variable Mapping
PX091601_Age
PX091601360000 Age Variable Mapping
PX091601_Barometric_Pressure
PX091601040000 Barometric pressure Variable Mapping
PX091601_Blank10
PX091601730000 Blank 10 N/A
PX091601_Blank1_Or_FEF25
PX091601640000 Blank 1 or FEF25% Variable Mapping
PX091601_Blank2_Or_FEF50
PX091601650000 Blank 2 or FEF50% Variable Mapping
PX091601_Blank3_Or_FEF75
PX091601660000 Blank 3 or FEF75% Variable Mapping
PX091601_Blank4_Or_FEF90
PX091601670000 Blank 4 or FEF90% N/A
PX091601_Blank5
PX091601680000 Blank 5 N/A
PX091601_Blank6
PX091601690000 Blank 6 N/A
PX091601_Blank7
PX091601700000 Blank 7 N/A
PX091601_Blank8
PX091601710000 Blank 8 N/A
PX091601_Blank9
PX091601720000 Blank 9 N/A
PX091601_BTPS_Calculation_Temperature
PX091601050000 Temperature (ºC) used in BTPS calculation N/A
PX091601_BTPS_Factor
PX091601190000 BTPS factor Variable Mapping
PX091601_Calibration_Date
PX091601290000 Calibration date N/A
PX091601_Calibration_Result
PX091601310000 Calibration result Variable Mapping
PX091601_Calibration_Time
PX091601300000 Calibration time Variable Mapping
PX091601_City
PX091601230000 City N/A
PX091601_Comments_Text
PX091601620000 Comments text Variable Mapping
PX091601_Computer_Quality
PX091601140000 Computer quality code Variable Mapping
PX091601_Country
PX091601260000 Country N/A
PX091601_Data_Type
PX091601030000 Data type N/A
PX091601_Date
PX091601320000 Date N/A
PX091601_Date_Of_Birth
PX091601410000 Date of birth Variable Mapping
PX091601_Date_Of_Review
PX091601170000 Date of review N/A
PX091601_Deleted_Maneuver
PX091601110000 Deleted manoeuvre Variable Mapping
PX091601_Effort_Attribute
PX091601090000 Effort attribute N/A
PX091601_Email
PX091601270000 E-mail N/A
PX091601_Extrapolated_Volume
PX091601490000 Extrapolated volume Variable Mapping
PX091601_FES_25_75
PX091601530000 FEF25-75% Variable Mapping
PX091601_FEV1
PX091601500000 FEV1 Variable Mapping
PX091601_FEV1_Quality
PX091601080000 FEV1 quality attribute Variable Mapping
PX091601_FEV6
PX091601510000 FEV6 Variable Mapping
PX091601_Flow_Data_Points
PX091601750000 Flow data points (mL/s; variable number more
contained in number of data points) show less
N/A
PX091601_Forced_Expiratory_Time
PX091601550000 Forced expiratory time Variable Mapping
PX091601_FVC
PX091601480000 FVC Variable Mapping
PX091601_FVC_Quality
PX091601070000 FVC quality attribute Variable Mapping
PX091601_Height
PX091601370000 Height Variable Mapping
PX091601_Maneuver_Number
PX091601350000 Manoeuvre number N/A
PX091601_Methacholine_Concentration
PX091601460000 Methacholine Concentration N/A
PX091601_Methacholine_Dose
PX091601470000 Methacholine dose N/A
PX091601_Number_Of_Data_Points
PX091601740000 Number of data points N/A
PX091601_Original_Sampling_Interval
PX091601630000 Original sampling interval N/A
PX091601_PEF
PX091601520000 PEF Variable Mapping
PX091601_Phone_Number
PX091601280000 Phone number N/A
PX091601_Plateau
PX091601150000 Plateau achieved Variable Mapping
PX091601_Predicted_FEV1
PX091601580000 Predicted FEV1 Variable Mapping
PX091601_Predicted_FEV1/FEV6
PX091601610000 Predicted FEV1/FEV6% Variable Mapping
PX091601_Predicted_FEV1/FVC
PX091601600000 Predicted FEV1/FVC% Variable Mapping
PX091601_Predicted_FEV6
PX091601590000 Predicted FEV6 N/A
PX091601_Predicted_FVC
PX091601570000 Predicted FVC Variable Mapping
PX091601_Race
PX091601400000 Race (2-character race code) Variable Mapping
PX091601_Reference_Value_Correction
PX091601430000 Reference values correction factor N/A
PX091601_Reference_Value_Source
PX091601420000 Reference values source (first author more
surname and date of publication, e.g.''Knudson 1983'') show less
N/A
PX091601_Relative_Humidity
PX091601060000 Relative humidity (%) N/A
PX091601_Review
PX091601160000 Review N/A
PX091601_Reviewer_Initials
PX091601180000 Reviewer initials N/A
PX091601_Sex
PX091601390000 Sex Variable Mapping
PX091601_Spirometer_Manufacturer
PX091601200100 Spirometer manufacturer N/A
PX091601_Spirometer_Model
PX091601200200 Spirometer model N/A
PX091601_Spirometer_Serial_Number
PX091601200300 Spirometer serial number N/A
PX091601_Spirometer_Type
PX091601210000 Spirometer type N/A
PX091601_State_Region
PX091601240000 State/region N/A
PX091601_Technician_ID
PX091601340000 Technician ID Variable Mapping
PX091601_Technician_Quality
PX091601130000 Technician quality control code Variable Mapping
PX091601_Testing_Facility
PX091601220000 Testing facility name N/A
PX091601_Testing_Position
PX091601440000 Testing position Variable Mapping
PX091601_Test_Type
PX091601450000 Test type N/A
PX091601_Time
PX091601330000 Time Variable Mapping
PX091601_Time_To_PEF
PX091601560000 Time to PEF Variable Mapping
PX091601_VC
PX091601540000 VC Variable Mapping
PX091601_Weight
PX091601380000 Weight Variable Mapping
PX091601_Zip_Code
PX091601250000 Zip/post code N/A
Respiratory
Measure Name

Spirometry

Release Date

January 29, 2010

Definition

Spirometry is a common pulmonary function test (PFT) measuring the amount (volume) and/or speed (flow) of air being inhaled and exhaled.

Purpose

Spirometry is a tool used to screen for the presence of obstructive and restrictive lung diseases.

Keywords

Respiratory, pulmonary function test, PFT, American Thoracic Society, ATS, European Respiratory Society, ERS, forced vital capacity, FVC, forced expiratory volume, FEV

Measure Protocols
Protocol ID Protocol Name
91601 Spirometry - Adult
91602 Spirometry - Child
Publications

Ross, J. M., et al. (2022) The effects of cannabis use on physical health: A co-twin control study. Drug and Alcohol Dependence. 2022 January; 230: 109200. doi: 10.1016/j.drugalcdep.2021.109200