Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
|Official Title:||Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia|
- The goal of this study is to evaluate ventilatory control during quiet breathing in subjects with tetraplegia by obtaining dyspnea scores and noninvasively measuring indices of motor output (tidal volume / inspiratory time, VT/TI). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- The goal of this study is to evaluate ventilatory control during quiet breathing in subjects with tetraplegia by obtaining dyspnea scores and noninvasively measuring indices of timing (inspiratory time/total breath time TI/TTOT). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 1999|
|Study Completion Date:||January 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
Spinal Cord Injury: subjects who have cervical spinal cord injury and complaints of dyspnea
Drug: ipratropium (Atrovent)
Bronchodilator Treatment: Subjects will inhale 1 unit dose vial of aerosolized ipratropium (500 mcg of ipratropium (Atrovent) mixed in 2.5 ml of saline).
No Intervention: 2
The goal of this study is to evaluate mechanisms of dyspnea in tetraplegia. This goal will be accomplished by completing the following specific objectives:
- To noninvasively assess dyspnea, motor drive, and respiratory timing during prolonged periods of resting breathing.
- To determine if relationships exist between these breathing pattern components and dyspnea.
- To determine if the relationships among respiratory timing, drive, and dyspnea are altered by a bronchodilator and over its duration of action.
These specific objectives will be used to test the hypotheses that:
- During prolonged periods of resting breathing, respiratory timing will be altered and motor drive will be increased and less variable than in able-bodied controls.
- There will be a positive association between motor drive and dyspnea.
- Improving respiratory mechanics by bronchodilator administration will reduce drive, normalize timing and lessen dyspnea over the duration of action of the drug.
Completion of the proposed studies will expand our existing knowledge of ventilatory control in persons with tetraplegia and relate these changes to dyspnea, a common and distressing clinical problem in these individuals. These studies will also provide a better characterization of breathing patterns and their intrasubject variability in persons with tetraplegia. Currently, the only information regarding breathing patterns in tetraplegia are of limited duration (15-30 minutes). If this pilot study reveals significant relationships between motor drive, timing, and dyspnea, compiling "normative" data for breathing patterns from large numbers of individuals with tetraplegia may be useful in evaluating dyspnea in different clinical settings.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904436
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Ann M. Spungen, EdD||VA Medical Center, Bronx|