CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Sub-Domain: 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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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 effort. 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

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

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

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

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

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-dependent. 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 cm H2O, representing the percentage of the predicted normal value of Maximal Inspiratory Pressure (MIP) a measure of the strength of respiratory muscles. Value, in cm H2O, representing the percentage of the predicted normal value 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 3.00 2013-07-22 16:57:17.79 Pulmonary Function Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Free-Form Entry

centimeter of water
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

C11106 Pulmonary function maximal expiratory pressure (MEP) result value PulmFuncMEPResltVal Value, representing the percentage of the predicted normal value of Maximal Expiratory Pressure (MEP) a measure of the strength of respiratory muscles. Value, representing the 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 3.00 2013-07-22 16:57:17.79 Pulmonary Function Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Free-Form Entry

centimeter of water
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&#8211;1270. <br />Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74&#8211;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&#8211;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&#8211;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

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 expiration. 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 ForcedVitalCapacityReslt Value representing 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 representing 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 3.00 2013-07-22 16:57:17.79 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 Whether the Forced Vital Capacity (FVC) flow volume crossed the x-axis 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 3.00 2013-07-22 16:57:17.79 Pulmonary Function Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Single Pre-Defined Value Selected

C10173 Forced expiratory volume second result ForcedExpiratoryVolumSecondRes Value representing the Amount of air, in Liters, that can be blown in the first second in the FVC maneuver (FEV1) Value representing the Amount of air, in Liters, that can be blown in the first second in the FVC 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 3.00 2013-07-22 16:57:17.79 Pulmonary Function Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Free-Form Entry

liter
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 strength. 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 breath. 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
C11098 Pulmonary function test date and time PulmFuncTestDateTime Date the pulmonary function test was performed Date 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 3.00 2013-07-24 11:38:01.2 Pulmonary Function Pulmonary Function Testing/Respiratory Status Outcomes and End Points

Free-Form Entry

CSV