Functional Electrical Stimulation for Production of Artificial Cough - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

September 30, 2009

Start Date ^ICMJE

December 1993

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00589199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of respiratory complications [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Functional Electrical Stimulation for Production of Artificial Cough

Official Title ^ICMJE

Functional Electrical Stimulation for Production of Artificial Cough

Brief Summary

The purpose of the present study is to assess the utility of abdominal muscle stimulation to provide large positive airway pressures and expiratory airflow thus simulating cough. Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory complications such as atelectasis, respiratory tract infections and respiratory failure.

Detailed Description

Cough is a complex defensive respiratory reflex mechanism necessary for the clearance of respiratory secretions and foreign materials. In patients with chronic bronchitis, previous investigations have found that the cough mechanism is the most effective measure to enhance mucous clearance from the lung.

Patients with cervical and thoracic spinal cord injuries have suffered a loss of the major portion of their expiratory muscles. Consequently, they are unable to generate significant positive intrathoracic airway pressures or airflow and have a markedly increased risk of developing pulmonary infections. Mechanical methods have been developed to enhance cough production. However, these have resulted in only marginal increases in airway pressure.

Preliminary studies in our laboratory in animal experiments and those of others in humans have suggested that the abdominal muscles can be stimulated directly by surface electrodes. The purpose of the present study, therefore, is to assess the utility of abdominal muscle stimulation in quadriplegics and paraplegics to simulate cough. A range of stimulus parameters and electrode locations will be assessed to determine optimal stimulus paradigms. Airway pressure and expiratory airflow will be used as indices of cough effectiveness. If successful, abdominal muscle stimulation may be a useful tool to restore cough and hopefully reduce the incidence of respiratory complications such as atelectasis and infection in spinal cord injured patients.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Parallel Assignment

Condition ^ICMJE

Spinal Cord Injuries
Paralysis

Intervention ^ICMJE

Procedure: Placement and use of the device

Study Arms / Comparison Groups

Experimental: Procedure/Surgery: Surface electrodes will be applied to the abdominal wall and over the posterior lower thoracic rib cage.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with cervical or thoracic spinal cord injury

Exclusion Criteria:

Significant cardiovascular disease
Active lung disease
Pacemaker or other metallic implant
Legally incompetent

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00589199

Responsible Party

Anthony F. DiMarco, MD/Principal Investigator, MetroHealth Medical Center and Case Western Reserve University

Study ID Numbers ^ICMJE

IRB93-00133

Study Sponsor ^ICMJE

Case Western Reserve University

Collaborators ^ICMJE

MetroHealth Medical Center

Investigators ^ICMJE

Principal Investigator:

Anthony F DiMarco, MD

MetroHealth Medical Center and Case Western Reserve University

Information Provided By

Case Western Reserve University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP