Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyspnea; Tetraplegia
Intervention: ipratropium (Atrovent) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Ann M. Spungen, EdD, Principal Investigator, Affiliation: VA Medical Center, Bronx
Summary
Breathlessness is an extremely common and uncomfortable symptom that is reported in more
than two-thirds of persons with tetraplegia. This disordered pulmonary function is due to
respiratory muscle paralysis or to sympathetic denervation results in a restrictive
impairment and airway hyperreactivity, respectively. These restrictive and obstructive
dysfunctions have been associated with the symptom of breathlessness. However, mechanisms
contributing to dyspnea in persons who have tetraplegia are not well understood. It has been
demonstrated that persons with tetraplegia have an increased prevalence of breathlessness
and may have an altered breathing pattern. The purpose of this study is to determine the
breathing pattern at rest and measure the changes in breathing after a bronchodilator
treatment (a medicine commonly used to treat asthma that relaxes and opens up airways). The
determination of breathing pattern is done by measuring the movements in the chest wall
while breathing. This design will elucidate differences in breathing patterns between those
with tetraplegia and controls, as well as demonstrate the effect of bronchodilatation on
motor drive and timing. Knowledge of the intraindividual variability and mean values of the
components of the breathing pattern will improve our understanding of breathlessness in
these individuals.
Clinical Details
Official title: Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Primary outcome: 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).
Secondary outcome: 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).
Detailed description:
The goal of this study is to evaluate mechanisms of dyspnea in tetraplegia. This goal will
be accomplished by completing the following specific objectives:
1. To noninvasively assess dyspnea, motor drive, and respiratory timing during prolonged
periods of resting breathing.
2. To determine if relationships exist between these breathing pattern components and
dyspnea.
3. 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:
1. 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.
2. There will be a positive association between motor drive and dyspnea.
3. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subjects who have cervical spinal cord injury
2. Complaints of dyspnea
3. Healthy non-paralyzed controls
Exclusion Criteria:
1. Active pulmonary infection
2. Current history of chronic pulmonary disease or asthma
3. Current smoker (> 0. 5 ppd)
4. Age < 18 or > 60 years
5. Duration of spinal cord injury < 1 year
6. Unable to sit upright in a chair or wheelchair for a full day
7. Persons taking anticholinergic (e. g., ditropan) or gaba (e. g., baclofen) agents
Locations and Contacts
VA Medical Center, Bronx, Bronx, New York 10468, United States
Additional Information
Starting date: December 1999
Last updated: May 18, 2009
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