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Protocol - Lung Function - Lung Volume

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Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Description:

The American Thoracic Society (ATS) and the European Respiratory Society (ERS) Task Force recommendations for standardisation of the measurement of lung volume testing outline how to obtain measurement of functional residual capacity (FRC) using body plethysmography, nitrogen washout, helium dilution, and imaging techniques. In addition, this source contains details regarding the assessment of total lung capacity (TLC), vital capacity (VC), reserve volume (RV), expiratory reserve volume (ERV), and inspiratory capacity (IC).

These recommendations for standardization of the measurement of lung volume testing are part of a series of recommendations by the ATS/ERS Task Force for the standardization of lung function testing, which can be found on the ATS website at [link[www.thoracic.org/statements/pulmonary-function.php|www.thoracic.org/statements/pulmonary-function.php]]. Detailed information regarding patient preparation is included in the general considerations document for lung function testing in this series.

Protocol:

Lung Function Testing: Measurement of Lung Volume

The American Thoracic Society (ATS) and the European Respiratory Society (ERS) Task Force recommendations for standardisation of the measurement of lung volumes can be found [link[www.phenx.org/Portals/0/phenx-content/Supplements/SickleCell/WG1/DocumentsForReview/Documents_for_Additional_Information/04_Lung_Function_Lung_Volume.pdf|here]] as well as on the ATS website [link[www.thoracic.org/statements/resources/pft/pft3.pdf|here]].

Personnel and Training Required

Certified respiratory therapist

Equipment Needs

Equipment needed for the calculation of lung volumes are outlined in the American Thoracic Society (ATS) and the European Respiratory Society (ERS) Task Force recommendations for standardisation of the measurement of lung volumes can be found [link[www.phenx.org/Portals/0/phenx-content/Supplements/SickleCell/WG1/DocumentsForReview/Documents_for_Additional_Information/04_Lung_Function_Lung_Volume.pdf|here]] as well as on the ATS website [link[www.thoracic.org/statements/resources/pft/pft3.pdf|here]].

Requirements

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

Mode of Administration

Self-administered

Life Stage:

Child, Adolescent, Adult, Senior, Pregnancy

Specific Instructions:

A comprehensive evaluation of lung function requires investigation of various aspects of the lung, such as lung volumes and diffusion capacity. Hence, the American Thoracic Society (ATS) and the European Respiratory Society (ERS) Task Force have published a series of documents regarding pulmonary function testing. The Sickle Cell Disease: Cardiovascular, Pulmonary, and Renal Working Group recommends researchers access the ATS website ([link[www.thoracic.org/|www.thoracic.org/]]) to view other documents in this series that may apply to their area of research.

Additionally, although there are various methods to measure functional residual capacity (FRC), the Working Group views body plethysmography as the most accurate, particularly when airflow obstruction is a possible underlying condition.

Research Domain Information

Release Date:

July 30, 2015

Definition

Clinical assessment to determine the volume of gas within an individual’s lung.

Purpose

This measure can be used to differentiate obstructive and restrictive pulmonary conditions and to detect and quantify symptoms associated with conditions that impact the lung, such as sickle cell disease, cystic fibrosis, and obstructive airway disease.

Selection Rationale

The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group recommends the American Thoracic Society (ATS) and the European Respiratory Society (ERS) Task Force 2005 recommendations for standardisation of the measurement of lung volumes because this document integrates and consolidates the task force recommendations and the recommendations from various National Heart, Lung, and Blood Institute (NHLBI) workshops.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Lung Forced Expiratory Volume 1 Test Value2629105CDE Browser

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Wanger, J., Clausen, J. L., Coates, A., Pedersen, O. F., Brusasco, V., Burgos, F., Casaburi, R., Crapo, R., Enright, P., van der Grinten, C. P. M., Gustafsson, P., Hankinson, J., Jensen, R., Johnson, D., MacIntyre, N., McKay, R., Miller, M. R., Navajas, D., Pellegrino, R., & Viegi, G. (2005). Standardisation of the measurement of lung volumes. European Respiratory Journal, 26, 511-522. doi: 10.1183/09031936.05.00035005

General References

Arteta, M., Campbell, A., Nouraie, M., Rana, S., Onyekwere, O. C., Ensing, G., Sable, C., Dham, N., Darbari, D., Luchtman-Jones, L., Kato, G. J., Gladwin, M. T., Castro, O. L., Minniti, C. P., & Gordeuk, V. R. (2014). Abnormal pulmonary function and associated risk factors in children and adolescents with sickle cell anemia. Journal of Pediatric Hematology/Oncology, 36(3), 185-189.

Lunt, A., Desai, S. R., Wells, A. U., Hansell, D. M., Mushemi, S., Melikian, N., Shah, A. M., Thein, S. L., & Greenough, A. (2014). Pulmonary function, CT and echocardiographic abnormalities in sickle cell disease, Thorax 69(8), 746-751.

Protocol ID:

810401

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX810401_Standardisation_LungVolumeMeasurement_VCPX810401010000Which of the following ways is the measurement for vital capacity taken?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Myocardial_InfarctionPX810401020000Has the subject suffered from myocardial infarction within the last month?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_ConditionsPX810401030000Does the subject suffer from any of the following conditions: chest or abdominal pain of any cause, oral or facial pain exacerbated by a mouthpiece, stress incontinence, dementia or confusional state?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_ActivitiesPX810401040000Was the subject involved in any of the following activities? Smoke within at least 1 hour of testing, consuming alcohol within 4 hours of testing, performing vigorous exercise within 30 minutes of testing, wearing clothing that substantially restricts full chest and abdominal expansion, eating a large meal within 2 hours of testing4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_PositionPX810401050100Which position will the subject be in for the duration of the test?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Position_OtherPX810401050200Which position will the subject be in for the duration of the test? Other4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_AgePX810401060000What is the subject's age?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_HeightPX810401070000What is the subject's height? (without shoes, feet together)4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Thoracic_DeformityPX810401080100Does the subject suffer from any deformity of the thoracic cage, such as kyphoscoliosis?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Arm_SpanPX810401080200If so, what is the subject's arm span from fingertip to fingertip?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_OtherHandicapPX810401090100Does the subject suffer from any handicap which prevents an accurate measurement from standing height or arm span length?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Knee_HeightPX810401090200If so, what is the subject's knee height?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_WeightPX810401100000What is the subject's weight?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_BmiPX810401110000What is the subject's body mass index?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_MedicationsPX810401120100Is the subject currently taking any medication that may alter lung function?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Medications_TypePX810401120200If so, what type of medication is the subject taking?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Medications_LastTimePX810401120300If so, when was the last time the drugs were administered?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_DenturePX810401130000Does the subject wear any denture or dental treatments that are loose and/or that may interfere with performance?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Current_TemperaturePX810401140000What is the current ambient temperature?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Current_BarometricPressurePX810401150000What is the current barometric pressure?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Current_TimePX810401160000What is the current time?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Return_TestingPX810401170100Is the subject returning for repeat testing?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Repeat_EquipmentTesterPX810401170200If so, is the equipment and operator from the previous session the same?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Repeat_TimeRestrictionPX810401170300If so, is the current test time within 2 hours of the previous test time?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_Repeat_OrderConservedPX810401180000Is the planned order of lung function tests identical to previous tests?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_DiseaseOr_IllnessPX810401190000Does the subject currently suffer from upper respiratory or any other contagious disease or illness?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_AbilityTo_CooperatePX810401200000Does the subject show signs of limited ability to cooperate?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subject_OralSoresPX810401210000Does the subject suffer from open oral sores or cuts?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Equipment_Reusable_ComponentsPX810401220000Has reusable equipment (such as mouthpieces, breathing tubes, valves and manifolds or any other equipment showing visible condensation from expired air) been disinfected/sterilized?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Equipment_Closed_CircuitPX810401230000Since the previous subject, if a closed-circuit technique was used, were volume-based spirometers flushed with room air at least five times over the entire volume range?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Equipment_OpenCircuit_ReplacementPX810401240000Since the previous subject, if an open-circuit technique was used and the subject only expires into the spirometer, was the portion of the circuit which rebreathing occurs properly decontaminated?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Equipment_OpenCircuit_MouthpiecePX810401250000Since the previous subject, if an open-circuit technique was used, were volume- and flow-based spirometers used without inspiration from the measuring system had their outhpieces replaced/sterilized?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Spirometer_RecalibrationPX810401260000If the spirometer was disassembled and cleaned, was the device re-calibrated?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Subjects_Infected_PrecautionsPX810401270000For subjects with transmissible infectious diseases, were any of the following precautions taken? Reserving equipment for the sole purpose of testing infected patients, testing such patients at the end of the day to allow time for spirometer disassembly and disinfection, testing patients in their own rooms with adequate ventilation and appropriate protection for the technician4N/A
PX810401_Standardisation_LungVolumeMeasurement_Inline_FilteredPX810401280000If in-line filters are being used, does the measuring system meet the minimum recommendations for accuracy, precision (reproducibility), flow resistance, and back pressure with the filter installed?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_QualificationsPX810401290000Do personnel have the sufficient education (2 years college education) and training to understand the fundamentals of the test, know the common signs of pulmonary disease, and be able to manage acquired pulmonary function data?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_FormalTrainingPX810401300000For personnel directly involved in pulmonary function testing, do they have formal training emphasis in health-related sciences (such as nursing, medical assistant, respiratory therapy, etc)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_CompetencyPX810401310000For personnel directly involved in pulmonary function testing, have they established competency in pulmonary function testing? (familiarity with theory and practical aspects of all commonly applied techniques, measurements, calibrations, hygiene, quality control, basic knowledge in lung physiology and pathology)4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_TrainingProgramPX810401320000Has personnel completed training similar to the National Institute for Occupational Safety and Health (NIOSH)-approved spirometry program?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_CompetencyExamPX810401330000Has personnel passed a written and practical examination in the presence of an experienced instructor?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_RefreshTrainingPX810401340000If it has been more than 3 years since his/her last competency exam or if lung function standards have been recently updated, have personnel taken a spirometry refresher training course?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_NotebookOf_RecordsPX810401350000Are personnel maintaining a notebook of recoreds including but not limited to: calibration procedures, test-performance procedures, calculations, criteria, reference values source, and action to be taken when 'panic' values are observed?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Personnel_Notebook_DetailPX810401360000Are there detailed statements and/or publications on the selection of references values and interpretation of lung function tests along with an assessment of the reliability of the data?4N/A
PX810401_Standardisation_LungVolumeMeasurement_MethodOf_MeasurementPX810401370100Which method from lung volume measurement is being used?4N/A
PX810401_Standardisation_LungVolumeMeasurement_FirstMethod_FrcPX810401370201If first method, what is the reported value for the functional residual capacity (mean of technically satisfactory FRC measurements)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_FirstMethod_ErvPX810401370202If first method, what is the reported value for the (technically satisfactory) expiratory reserve volume (ERV)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_FirstMethod_IvcPX810401370203If first method, what is the reported value for the (technically satisfactory) inspiratory vital capacity (IVC)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_FrcPX810401370301If second method, what is the reported value for the functional residual capacity (mean of technically satisfactory FRC measurements)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_ErvPX810401370302If second method, what is the reported value for the (technically satisfactory) expiratory reserve volume (ERV)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_Approach_VcPX810401370303If second method, which approach is used to derive the value for vital capacity?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_Approach_IvcPX810401370304If second method, and using the IVC/ERV approach, what is the reported value for the (technically satisfactory) inspiratory vital capacity (IVC)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_Approach_Largest_VcPX810401370305If second method, and using the IVC/ERV approach, what is the largest measurement obtained for the vital capacity (VC)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_Approach_IcPX810401370306If second method, and using the slow EVC approach, what is the mean of technically satisfactory inspiratory capacity (IC) measurements?4N/A
PX810401_Standardisation_LungVolumeMeasurement_SecondMethod_Approach_TlcPX810401370307If second method, what is the calculated value for total lung capacity (TLC)? (mean of three largest sums of technically acceptable FRC values and linked IC manuevers)4N/A
PX810401_Standardisation_LungVolumeMeasurement_Method_FrcPX810401380000Which method is used for measuring forced residual capacity (FRC)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_TypePX810401390000If body plethysmography method is used to measure FRC, which type of plethysmograph is used to track changes in thoracic volume?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_ConstantPressure_AirflowPX810401390101If flow plethysmograph, what is the airflow rate in and out of the constant-pressure chamber?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_TransducerPX810401390102If body plethysmography method is used to measure FRC, is the transducer capable of measure mouth pressure greater than +/- 5kPa?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_Measurement_TechniquePX810401390103If body plethysmography method is used to measure FRC, does the measurement technique adhere to the following steps? 1) Equipment should be turned on and allowed an adequate time to warm up; 2) Equipment is set up for testing, including calibration, according to manufacturer's instructions; 3) Equipment is adjusted so that the patient can sit comfortably in the chamber and reach the mouthpiece without having to flex or extend the neck; 4) Patient is seated comfortably with no need to remove dentures; 5) The plethysmograph door is closed and time is allowed for the thermal transients to stabilize and the patient to relax; 6) The patient is instructed to attach to the mouthpiece and breathe quietly until a stable end-expiratory level is achieved (usually 3-10 tidal breaths); 7) When the patient is at or near FRC, the shutter is closed at end-expiration for ~2-3 seconds and the patient is instructed to perform a series of gentle pants (~+/- kPa) at a frequency between 0.5 and 1.0 Hertz; 8) A series of 3-5 technically satisfactory panting manuevers should be recorded; 9) For those unable to perform appropriate panting manuevers, an alternative is to perform a rapid inspiratory manuever against the closed shutter; 10) At least three FRC values that agree within 5% (i.e. difference between the highest and value divided by the mean <= 0.05) should be obtained and mean value reported4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_FrcPX810401390104If body plethysmography method is used to measure FRC, what is the reported FRC value?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_CalibrationPX810401390105If body plethysmography method is used to measure FRC, was the mouth pressure transducer and plethysmograph signal calibrated within the past 24 hours?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_Calibration_ControlsPX810401390106If body plethysmography method is used to measure FRC, at least once a month or whenever plethysmographic errors are suspected, was the plethysmograph recalibrated with two reference subjects (biological controls)?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_ConstantVolumePX810401390201If variable-pressure plethysmograph, what is the pressure within the constant-volume chamber?4N/A
PX810401_Standardisation_LungVolumeMeasurement_BodyPleth_ConstantPressurePX810401390301If volume-displacement plethysmograph, what is the volume within the constant-pressure chambler?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_Quality_ControlPX810401400100If nitrogen washout method is used to measure FRC, does the N2 analyzer have an inaccuracy <= 0.2% of full range throughout the entire measuring range (0-80%), have a resolution of <= 0.01%, and have a 95% analyzer response time of <= 60 milliseconds to a 10% step change in nitrogen concentration?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_CalibrationPX810401400200If nitrogen washout method is used to measure FRC, were pneumotachographs and other flow-measuring devices calibrated within the last 24 hours by discharging a 3-liter syringe at least 3 times giving a flow range of 0-6L/s?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_SamplingRatePX810401400300If nitrogen washout method is used to measure FRC, for flow and nitrogen signals, does the system have a sampling rate of >= 40 samples/sec?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_BreathingValvePX810401400400If nitrogen washout method is used to measure FRC, does the breathing valve for switching the patient from breathing room air to pure oxygen have a dead space of less than 100mL for adults and <2mL/kg in smaller children?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_Measurement_TechniquePX810401400500If nitrogen washout method is used to measure FRC, does the measurement technique adhere to the following steps? 1) Equipment is turned on and allowed an adequate warm-up time, with calibration as instructed by manufacturer; 2) Patient should be asked if he/she has a perforated eardrum (if so, earplug should be used); 3) Patient is seated comfortable with no need to remove dentures. The procedure is explained, emphasizing the need to avoid leaks around the mouthpiece during the washout and using a nose clip; 4) Patient breathes on the mouthpieces for ~30-60 seconds to become accustomed to the apparatus and to assure a stable end-tidal expiratory level; 5) when breathing is stable and consistent with the end-tidal volume being at FRC, the patient is switched into the circuit so that 100% oxygen is inspired instead of room air; 6) The nitrogen concentration is monitored during the washout. A change in inspired N2 of >1% or sudden large increases in expiratory N2 concentrations indicate a leak; hence the test should be stopped and repeated after a 15-minute period of breathing room air. The washout is considered to be complete when the N2 concentration is less than 1.5% for at least three successive breaths; 8) At least one technically satisfactory measurement should be obtained. If additional washouts are performed, a waiting period of >= 15 minutes is recommended between trials. In patients with severe obstructive or bullous disease, the time between trials should be >= 1 hour. If more than one measurement of FRCN2 is made, the value reported for FRCN2 should be the mean of technically acceptable results that agree within 10%. If only one measurement of FRCN2 is made, caution should be used in the interpretation.4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_Calibration_ZeroPX810401400600If nitrogen washout method is used to measure FRC, was the N2 analyzer tared to zero using 100% O2 and then exposed to room air to confirm calibration? The percentage of N2 for room air should be within 0.5% of the expected reading for room air4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_RecalibrationPX810401400700If nitrogen washout method is used to measure FRC, before initial use and once every 6 months thereafter, was the linearity of the N2 analyzer confirmed by measuring the N2 percentage of a calibration gas mixture, where the expected N2 concentration is ~40% and observed values are within 0.5% of the expected concentration?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_Calibration_DayPX810401400800If nitrogen washout method is used to measure FRC, before use, was the accuracy of the flow and volume output measured by the device confirmed within the past 24 hours with a calibrating syringe?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Nitrogen_Calibration_ControlsPX810401400900If nitrogen washout method is used to measure FRC, was the performance of the device tested with biological controls at least once in the past month?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Spirometer_QualityControlPX810401410100If helium dilution method is used to measure FRC, is the capacity of the spirometer at least 7 liters and is the device equipped with a mixing fan, CO2 absorber, O2 and helium supply, a gas inlet and outlet, and a water vapour absorber in the line to the helium analyzer?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_CalibrationStepPX810401410200If helium dilution method is used to measure FRC, before measurements are taken, was enough 100% helium added to the system where the helium reading was ~10%?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_FlowPX810401410300If helium dilution method is used to measure FRC, does the device have a flow of ~50 L/min?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Analyzer_TypePX810401410400If helium dilution method is used to measure FRC, what type of analyzer is being used?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Analyzer_TypeOtherPX810401410500If helium dilution method is used to measure FRC, what type of analyzer is being used? Other4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Analyzer_RangePX810401410600If helium dilution method is used to measure FRC, does the helium analyzer have a range of ~0-10% helium, a resolution of <= 0.01% helium over the entire range, and a 95% response time of <15seconds to a 2% step change in helium concentration?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Analyzer_StabilityPX810401410700If helium dilution method is used to measure FRC, is the meter stable with a drift of <= 0.02% for measurement periods up to 10 minutes?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Oxygen_RecalibrationPX810401410800If helium dilution method is used to measure FRC, for systems in which O2 concentration changes substantially, was the helium analyzer recalibrated over the range of O2 concentrations encountered?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Analyzer_FlowPX810401410900If helium dilution method is used to measure FRC, does the helium analyzer allow a flow of >=200 mL/min?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_CarbonDioxidePX810401411000If helium dilution method is used to measure FRC, is the breathing-circuit CO2 levels during testing below 0.5%?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_TemperaturePX810401411100If helium dilution method is used to measure FRC, what is the temperature of the gas in the breathing circuit?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Temperature_SensorPX810401411200If helium dilution method is used to measure FRC, does the temperature sensor have an accuracy of better than 0.5 degrees Celsius over the range of 12-30 degrees Celsius and have a 90% response time of <30 seconds to a 5 degree Celsius step change of temperature of the gas inside the breathing circuit?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_DeadSpacePX810401411300If helium dilution method is used to measure FRC, does the breathing valve and mouthpiece have a combined dead space <100mL?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Measurement_TechniquePX810401411400If helium dilution method is used to measure FRC, does the measurement technique adhere to the following steps? 1) Equipment is turned on and allowed an adequate warm-up time, with calibration as instructed by manufacturer; 2) The equipment should be set up for testing, including calibration, according to manufacturer's instructions; 3) Patient should be asked if he/she has a perforated eardrum (if so, earplug should be used); 4) Patient is seated comfortable with no need to remove dentures. The procedure is explained, emphasizing the need to avoid leaks around the mouthpiece during the washout and using a nose clip; 5) The patient breathes for ~30-60 seconds on the mouthpiece to become accustomed to the apparatus and to ensure a stable end-tidal expiratory level; 6) The patient is turned 'in' (i.e. connected to the test gas) at the end of a normal tidal expiration; 7) The patient is instructed to breathe regular tidal breathes; 8) The O2 flow is adjusted to compensate for O2 consumption (significant errors in the calculation of FRC can result in O2 consumption is not adequately accounted for); 9) The helium concentration is noted ever 15s; 10) Helium equilibration is considered to be complete when the change in helium concentration is <0.02% for 30 seconds. The test rarely exceeds 10 minutes, even in patients with severe gas-exchange abnormalities; 11) Once the helium equilibration is complete, the patient is turned 'out' (i.e. disconnected from the test gas) of the system; 12) At least one technically satisfactory measurement should be obtained. Due to extra costs and time in making multiple measurements, and the relatively good inter-day variability in adults, two or more measurements of FRC need to be made only when necessitated by clinical or research need. For younger children, it is recommeneded that at least two technically satisfactory measurements of FRC to be carried out.4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Quality_ControlPX810401411500If helium dilution method is used to measure FRC, before the subject was tested, were the following items checked? Water level of water-sealed spirometer; status of all CO2 and water absorbers; operation of the circuit fan; baseline stability of helium and volume signals4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Leak_CheckPX810401411600If helium dilution method is used to measure FRC, for systems that can be pressurized, were leaks checked for at least once in the past 24 hours and/or after every tubing or canister changes?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Stability_TemperaturePX810401411700If helium dilution method is used to measure FRC, was the stability (<0.02% drift in 10 min) and temperature of the helium meter checked at least once in the past week?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Helium_Calibration_ControlPX810401411800If helium dilution method is used to measure FRC, was testing of biological controls performed at least once in the past month?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Imaging_TechniquePX810401420200If the subject has limited ability to cooperate, which imaging technique method will be used to measure his/her lung volume?4N/A
PX810401_Standardisation_LungVolumeMeasurement_Imaging_Technique_OtherPX810401420300If the subject has limited ability to cooperate, which imaging technique method will be used to measure his/her lung volume? Other4N/A