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Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia

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ClinicalTrials.gov Identifier: NCT00904436
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : May 19, 2009
Information provided by:
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment
Dyspnea Tetraplegia Drug: ipratropium (Atrovent)

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia
Study Start Date : December 1999
Primary Completion Date : January 2001
Study Completion Date : January 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904436

United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Ann M. Spungen, EdD VA Medical Center, Bronx

Responsible Party: Spungen, Ann - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00904436     History of Changes
Other Study ID Numbers: B2648C-1
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: May 2009

Keywords provided by VA Office of Research and Development:
Breathing Patterns

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action