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Protocol - Spirometry - Adult

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Protocol Name from Source:

Spirometry

Availability:

Publicly available

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. The subject’s 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 1 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.

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
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingYes

Mode of Administration

Self-administered

Life Stage:

Adolescent, Adult

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.

Research Domain Information

Release Date:

November 28, 2017

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.

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

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Pulmonary Function Test Measurement Text2970229CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Resp spirometry proto62639-0LOINC

Process and Review

[link[phenx.org/node/118|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[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=90000|link]])

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 NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX091601_Data_TypePX091601030000Data type4N/A
PX091601_Barometric_PressurePX091601040000Barometric pressure4Variable Mapping
PX091601_BTPS_Calculation_TemperaturePX091601050000Temperature (ºC) used in BTPS calculation4N/A
PX091601_Relative_HumidityPX091601060000Relative humidity (%)4N/A
PX091601_FVC_QualityPX091601070000FVC quality attribute4Variable Mapping
PX091601_FEV1_QualityPX091601080000FEV1 quality attribute4Variable Mapping
PX091601_Effort_AttributePX091601090000Effort attribute4N/A
PX091601_Deleted_ManeuverPX091601110000Deleted manoeuvre4Variable Mapping
PX091601_Acceptable_ManeuverPX091601120000Acceptable manoeuvre4Variable Mapping
PX091601_Technician_QualityPX091601130000Technician quality control code4Variable Mapping
PX091601_Computer_QualityPX091601140000Computer quality code4Variable Mapping
PX091601_PlateauPX091601150000Plateau achieved4Variable Mapping
PX091601_ReviewPX091601160000Review4N/A
PX091601_Date_Of_ReviewPX091601170000Date of review4N/A
PX091601_Reviewer_InitialsPX091601180000Reviewer initials4N/A
PX091601_BTPS_FactorPX091601190000BTPS factor4Variable Mapping
PX091601_Spirometer_ManufacturerPX091601200100Spirometer manufacturer4N/A
PX091601_Spirometer_ModelPX091601200200Spirometer model4N/A
PX091601_Spirometer_Serial_NumberPX091601200300Spirometer serial number4N/A
PX091601_Spirometer_TypePX091601210000Spirometer type4N/A
PX091601_Testing_FacilityPX091601220000Testing facility name4N/A
PX091601_CityPX091601230000City4N/A
PX091601_State_RegionPX091601240000State/region4N/A
PX091601_Zip_CodePX091601250000Zip/post code4N/A
PX091601_CountryPX091601260000Country4N/A
PX091601_EmailPX091601270000E-mail4N/A
PX091601_Phone_NumberPX091601280000Phone number4N/A
PX091601_Calibration_DatePX091601290000Calibration date4N/A
PX091601_Calibration_TimePX091601300000Calibration time4Variable Mapping
PX091601_Calibration_ResultPX091601310000Calibration result4Variable Mapping
PX091601_DatePX091601320000Date4N/A
PX091601_TimePX091601330000Time4N/A
PX091601_Technician_IDPX091601340000Technician ID4Variable Mapping
PX091601_Maneuver_NumberPX091601350000Manoeuvre number4N/A
PX091601_AgePX091601360000Age4Variable Mapping
PX091601_HeightPX091601370000Height4Variable Mapping
PX091601_WeightPX091601380000Weight4Variable Mapping
PX091601_SexPX091601390000Sex4Variable Mapping
PX091601_RacePX091601400000Race (2-character race code)4Variable Mapping
PX091601_Date_Of_BirthPX091601410000Date of birth4Variable Mapping
PX091601_Reference_Value_SourcePX091601420000Reference values source (first author surname and date of publication, e.g.''Knudson 1983'')4N/A
PX091601_Reference_Value_CorrectionPX091601430000Reference values correction factor4N/A
PX091601_Methacholine_DosePX091601470000Methacholine dose4N/A
PX091601_FVCPX091601480000FVC4Variable Mapping
PX091601_Extrapolated_VolumePX091601490000Extrapolated volume4Variable Mapping
PX091601_FEV1PX091601500000FEV14Variable Mapping
PX091601_FEV6PX091601510000FEV64Variable Mapping
PX091601_PEFPX091601520000PEF4Variable Mapping
PX091601_FES_25_75PX091601530000FEF25-75%4Variable Mapping
PX091601_VCPX091601540000VC4Variable Mapping
PX091601_Forced_Expiratory_TimePX091601550000Forced expiratory time4Variable Mapping
PX091601_Time_To_PEFPX091601560000Time to PEF4Variable Mapping
PX091601_Predicted_FVCPX091601570000Predicted FVC4Variable Mapping
PX091601_Predicted_FEV1PX091601580000Predicted FEV14Variable Mapping
PX091601_Predicted_FEV6PX091601590000Predicted FEV64N/A
PX091601_Predicted_FEV1/FVCPX091601600000Predicted FEV1/FVC%4Variable Mapping
PX091601_Predicted_FEV1/FEV6PX091601610000Predicted FEV1/FEV6%4Variable Mapping
PX091601_Comments_TextPX091601620000Comments text4Variable Mapping
PX091601_Original_Sampling_IntervalPX091601630000Original sampling interval4N/A
PX091601_Blank1_Or_FEF25PX091601640000Blank 1 or FEF25%4Variable Mapping
PX091601_Testing_PositionPX091601440000Testing position4Variable Mapping
PX091601_Test_TypePX091601450000Test type4N/A
PX091601_Methacholine_ConcentrationPX091601460000Methacholine Concentration4N/A
PX091601_Blank2_Or_FEF50PX091601650000Blank 2 or FEF50%4Variable Mapping
PX091601_Blank3_Or_FEF75PX091601660000Blank 3 or FEF75%4Variable Mapping
PX091601_Blank4_Or_FEF90PX091601670000Blank 4 or FEF90%4N/A
PX091601_Blank5PX091601680000Blank 54N/A
PX091601_Blank6PX091601690000Blank 64N/A
PX091601_Blank7PX091601700000Blank 74N/A
PX091601_Blank8PX091601710000Blank 84N/A
PX091601_Blank9PX091601720000Blank 94N/A
PX091601_Blank10PX091601730000Blank 104N/A
PX091601_Number_Of_Data_PointsPX091601740000Number of data points4N/A
PX091601_Flow_Data_PointsPX091601750000Flow data points (mL/s; variable number contained in number of data points)4N/A