Functional Electrical Stimulation for Production of Artificial Cough

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Paralysis
• Interventions: Procedure: Placement and use of the device

• Registration Number: NCT00589199
• Lead Sponsor: MetroHealth Medical Center

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 Timeline

• Study Start: 1993-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Placement and use of the device	Functional Electrical Stimulation for Production of Artificial Cough

Primary Outcome Measures

Name	Time	Method
Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough	one year

Secondary Outcome Measures

Name	Time	Method
Incidence of respiratory complications	one year

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States