CDE Detailed Report
Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function
Displaying 1 - 19 of 19
Subdomain Name: Pulmonary Function Testing/Respiratory Status
CRF: Pulmonary Function
Displaying 1 - 19 of 19
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C11098 | Pulmonary function test date and time | PulmFuncTestDateTime | Date (and time, if applicable and known) the pulmonary function test was performed | Date (and time, if applicable and known) the pulmonary function test was performed | Date of Pulmonary Function Testing (PFT) | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm | Adult;Pediatric | Core | 3.10 | 2024-02-29 15:59:28.0 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
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| C11112 | Pulmonary function maximal voluntary ventilation (MVV) result value | PulmFuncMVVResltVal | Value representing the Maximal Voluntary Ventilation, in Liters per Minute, as the greatest volume of gas that can be breathed per minute by voluntary effort | Value representing the Maximal Voluntary Ventilation, in Liters per Minute, as the greatest volume of gas that can be breathed per minute by voluntary effor | MVV Results | Numeric Values |
Results should be recorded in liters per minute (L/min) for each trial. If MVV not performed, check N/A. |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
liter per minute | |||||||||
| C11099 | Pulmonary function test type | PulmFunctTestTyp | Type of pulmonary function testing performed | Type of pulmonary function testing performed | What type of pulmonary function testing is being performed? | Slow Vital Capacity;Maximum Inspiratory Pressure;Maximum Expiratory Pressure;Peak Expiratory Flow;Forced Vital Capacity;Forced Expiratory Volume in one second | Slow Vital Capacity;Maximum Inspiratory Pressure;Maximum Expiratory Pressure;Peak Expiratory Flow;Forced Vital Capacity;Forced Expiratory Volume in one second | Alphanumeric |
Check all that apply. Record results in appropriate tables on next page. A study should write detailed standard operating procedures (SOPs) for the pulmonary function testing to help ensure consistent measurements. The SOP should cover details like the equipment used, the position of the participant/subject for the measurements, etc. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Multiple Pre-Defined Values Selected |
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| C11114 | Pulmonary function sniff nasal inspiratory pressure (SNIP) congestion indicator | PulmFuncSNIPCongestionInd | Indicator as to whether or not the participant/subject has nasal congestion when Sniff Nasal Inspiratory Pressure (SNIP) was measured | Indicator as to whether or not the participant/subject has nasal congestion when Sniff Nasal Inspiratory Pressure (SNIP) was measured | Nasal Congestion | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
This question is answered for SNIP |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C11100 | Pulmonary function test position type | PulmFuncTestPositionTyp | Participant's/subject's position for the pulmonary function assessment | Participant's/subject's position for the pulmonary function assessment | Position for the assessment | Sitting;Supine;Both | Sitting;Supine;Both | Alphanumeric |
Choose one for each pulmonary function test performed. Supine should be used for Forced Vital Capacity (FVC) only. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C17832 | Pulmonary function maximum inspiratory pressure (MIP) type | PulmFuncMICTyp | Type of Maximum Inspiratory Pressure (MIP) | Type of Maximum Inspiratory Pressure (MIP) | Specify type below | Sniff Nasal Inspiratory Pressure;Maximal Voluntary Ventilation | Sniff Nasal Inspiratory Pressure (SNIP);Maximal Voluntary Ventilation (MVV) | Alphanumeric | No references available | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C11101 | Pulmonary function test mouth apparatus type | PulmFuncTestMouthApparTyp | Type of mouthpiece used for the pulmonary function test | Type of mouthpiece used for the pulmonary function test | What type of mouthpiece was used (if applicable)? | Scuba;Cardboard;Mask;Tube;Other | Scuba;Cardboard;Mask;Tube;Other | Alphanumeric |
If applicable |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C11104 | Pulmonary function slow vital capacity (sVC) result value | PulmFuncsVCResltVal | Value, in Liters, representing the slow Vital Capacity (SVC) maximal amount of air exhaled steadily from full inspiration to maximal expiration in liters. Not time-dependent | Value, in Liters, representing the slow Vital Capacity (SVC) maximal amount of air exhaled steadily from full inspiration to maximal expiration in liters. Not time-dependen | sVC Results | Numeric Values |
Results should be recorded in liters (L) for each trial. If sVC not performed, check N/A |
No references available | Adult | Core | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
liter | |||||||||
| C11105 | Pulmonary function maximal inspiratory pressure (MIP) result value | PulmFuncMIPResltVal | Value in centimeters of water (cm H2O) of Maximal Inspiratory Pressure (MIP) a measure of the strength of respiratory muscles | Value in centimeters of water (cm H2O) of Maximal Inspiratory Pressure (MIP) a measure of the strength of respiratory muscles | MIP Results | Numeric Values |
Results should be recorded in centimeters of water (cm H2O) for each trial. If MIP not performed, check N/A |
No references available | Adult | Exploratory | 3.10 | 2024-02-29 15:59:34.0 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
centimeter of water | |||||||||
| C02411 | Laterality type | LatTyp | Laterality type relative to the anatomic site of the body examined or affected | Laterality type relative to the anatomic site of the body examined or affected | Nare | Left;Right | Left;Right | Alphanumeric |
Choose one |
Kendall. Muscles: Testing and Function with Posture and Pain, 5th ed. Florence JM, Pandya S, King WM et al. Intrarater reliability of manual muscle test (Medical Research Council Scale) grades in Duchenne's muscular dystrophy. Phys Ther 1992;72:115-126. | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C11106 | Pulmonary function maximal expiratory pressure (MEP) result value | PulmFuncMEPResltVal | Value in centimeters of water (cm H2O) of Maximal Expiratory Pressure (MEP) a measure of the strength of respiratory muscles | Value in centimeters of water (cm H2O) of Maximal Expiratory Pressure (MEP) a measure of the strength of respiratory muscles | MEP Results | Numeric Values |
Results should be recorded in centimeters of water (cm H2O) for each trial. If MEP not performed, check N/A. |
No references available | Adult | Supplemental | 3.10 | 2024-02-29 15:59:35.0 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
centimeter of water | |||||||||
| C10171 | Trial number | TrialNum | The number representing the sequence for any repeated measure test or assessment when it is performed multiple times | The number representing the sequence for any repeated measure test or assessment when it is performed multiple times | Trial | Trial 1;Trial 2;Trial 3 | Trial 1;Trial 2;Trial 3 | Alphanumeric |
Record the results for each trial of the specific pulmonary function test |
Beck M, Giess R, Wuerffel W, Magnus T, Ochs, G, Toyka KV. Comparison of Maximal Voluntary Isometric Contraction and Drachman's Hand-Held Dynamometry in Evaluating Patients with Amyotrophic Lateral Sclosis. Muscle Nerve. 1999; 22: 1265–1270. <br />Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74–77.<br />Wang CY, Olson SL, Protas EJ. Test-Retest Strength Reliability: Hand-Held Dynamometry in Community-Dwelling Elderly Faller. Arch Phys Med Rehabil. 2002; 83: 811–815. <br />Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. 2012; 13(5):430–438.<br />http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C11107 | Pulmonary function peak expiratory flow result value | PulmFuncPEFResltVal | Value representing the Peak Expiratory Flow (PEF) as a person's maximum speed of expiration | Value representing the Peak Expiratory Flow (PEF) as a person's maximum speed of expiratio | PEF Results | Numeric Values |
Results should be recorded in liters per minute (L/min) for each trial. If PEF not performed, check N/A. |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
liter per minute | |||||||||
| C10172 | Forced vital capacity result value | ForcedVitalCapacityResltVal | Value of the Forced Vital Capacity (FVC), in liters, as the maximum volume of air that can be exhaled as rapidly, forcefully, and completely as possible from the point of maximal inhalation | Value of the Forced Vital Capacity (FVC), in liters, as the maximum volume of air that can be exhaled as rapidly, forcefully, and completely as possible from the point of maximal inhalation | FVC Results | Numeric Values |
Please repeat 3 times in assessment. |
http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm | Adult | Core | 4.10 | 2024-02-29 15:59:36.0 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
liter | |||||||||
| C11109 | Pulmonary function forced vital capacity (FVC) flow volume crossed x-axis indicator | PulmFunFVCFlowVolCrossXAxisInd | Indicator of whether the Forced Vital Capacity (FVC) flow volume crossed the x-axis | Indicator of whether the Forced Vital Capacity (FVC) flow volume crossed the x-axis | FVC Flow volume crossed X-axis | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. Answer for each trial performed. |
No references available | Adult | Supplemental | 3.10 | 2024-02-29 15:59:37.0 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10173 | Forced expiratory volume second result value | ForcedExpiratoryVolSecndResVal | Value of the amount of air, in liters, that can be blown in the first second in the Forced Expiratory Volume maneuver (FEV1) | Value of the amount of air, in liters, that can be blown in the first second in the Forced Expiratory Volume maneuver (FEV1) | FEV1 Results | Numeric Values |
Please repeat 3 times in assessment. |
http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm | Adult | Supplemental | 4.10 | 2024-02-29 15:59:35.0 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
liters per second | |||||||||
| C11110 | Pulmonary function sniff nasal inspiratory pressure (SNIP) result value | PulmFuncSNIPResltVal | Value representing the Sniff Nasal Inspiratory Pressure (SNIP), in cm H2O, as a measure of global inspiratory muscle strength | Value representing the Sniff Nasal Inspiratory Pressure (SNIP), in cm H2O, as a measure of global inspiratory muscle strengt | SNIP Results | Numeric Values |
Results should be recorded in liters (L) for each trial. If SNIP not performed, check N/A. |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
centimeter of water | |||||||||
| C10177 | Slow vital capacity percent of predicted normal value | SlowVitalCapPcntPredctdNormVal | Value representing the percentage of the predicted normal value of Slow Vital Capacity (sVC) to grade the severity of the abnormality, where sVC is the total amount of air that can be blown out leisurely after a maximal deep breath | Value representing the percentage of the predicted normal value of Slow Vital Capacity (sVC) to grade the severity of the abnormality, where sVC is the total amount of air that can be blown out leisurely after a maximal deep breat | sVC %of Predicted | Numeric Values |
Please repeat 3 times in assessment. |
http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm | Adult | Core | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
0 | 150 | percent | |||||||
| C11111 | Pulmonary function sniff nasal inspiratory pressure (SNIP) peak pressure value | PulmFuncSNIPPeakPressrVal | Value representing the peak Sniff Nasal Inspiratory Pressure (SNIP), in cm H2O, of three trials | Value representing the peak Sniff Nasal Inspiratory Pressure (SNIP), in cm H2O, of three trials | SNIP Peak Pressure Value | Numeric Values |
Results should be recorded in liters (L) |
No references available | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Pulmonary Function | Pulmonary Function Testing/Respiratory Status | Outcomes and End Points |
Free-Form Entry |
centimeter of water |
