Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia

Dyspnea Clinical Trial

Official title:

Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904436
• Other study ID #: B2648C-1
• Status: Completed
• Phase: N/A
• First received: May 14, 2009
• Last updated: May 18, 2009
• Start date: December 1999
• Est. completion date: January 2001

Study information

• Verified date: May 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dyspnea
• Quadriplegia
• Tetraplegia

Intervention

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).

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		2 years	No
Secondary	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).		2 years	No