Evaluation of Breathing Pattern and Dyspnea in Subjects With Tetraplegia

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00904436
First received: May 14, 2009
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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 Intervention
Dyspnea
Tetraplegia
Drug: ipratropium (Atrovent)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: December 1999
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Controls

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00904436

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: Ann M. Spungen, EdD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Spungen, Ann - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00904436     History of Changes
Other Study ID Numbers: B2648C-1
Study First Received: May 14, 2009
Last Updated: May 18, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Tetraplegia
Breathing Patterns
Dyspnea

Additional relevant MeSH terms:
Respiratory Aspiration
Dyspnea
Quadriplegia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Paralysis
Neurologic Manifestations
Nervous System Diseases
Ipratropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014