Functional Electrical Stimulation for Production of Artificial Cough

Spinal Cord Injuries Clinical Trial

Official title:

Functional Electrical Stimulation for Production of Artificial Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589199
• Other study ID #: IRB93-00133
• Status: Completed
• Phase: N/A
• Start date: December 1993
• Est. completion date: January 2010

Study information

• Verified date: July 2019
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Spinal Cord Injuries

Intervention

Procedure:
• Placement and use of the device
Surface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough		one year
Secondary	Incidence of respiratory complications		one year