Functional Electrical Stimulation for Production of Artificial Cough
|ClinicalTrials.gov Identifier: NCT00589199|
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : May 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Paralysis||Procedure: Placement and use of the device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Electrical Stimulation for Production of Artificial Cough|
|Study Start Date :||December 1993|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Procedure/Surgery: Surface electrodes will be applied to the abdominal wall and over the posterior lower thoracic rib cage.
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.
- Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough [ Time Frame: one year ]
- Incidence of respiratory complications [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589199
|United States, Ohio|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator:||Anthony F DiMarco, MD||MetroHealth Medical Center and Case Western Reserve University|