Functional Electrical Stimulation for Production of Artificial Cough

NCT00589199 | Completed

• 1 other identifier: IRB93-00133
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Paralysis

Outcome Measures

Primary Outcomes (1)

• Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough

  one year

Secondary Outcomes (1)

• Incidence of respiratory complications

  one year

Study Arms (1)

1

EXPERIMENTAL

Functional Electrical Stimulation for Production of Artificial Cough

Procedure: Placement and use of the device

Interventions

Placement and use of the device PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cervical or thoracic spinal cord injury

You may not qualify if:

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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paralysis

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Anthony F DiMarco, MD

  MetroHealth Medical Center and Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 9, 2008
• Study Start: December 1, 1993
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

US (1)