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Functional Electrical Stimulation for Production of Artificial Cough

Primary Purpose

Spinal Cord Injuries, Paralysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placement and use of the device
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Functional Electrical Stimulation for Production of Artificial Cough

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of respiratory complications

Full Information

First Posted
December 21, 2007
Last Updated
July 31, 2019
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00589199
Brief Title
Functional Electrical Stimulation for Production of Artificial Cough
Official Title
Functional Electrical Stimulation for Production of Artificial Cough
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 1993 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Functional Electrical Stimulation for Production of Artificial Cough
Intervention Type
Procedure
Intervention Name(s)
Placement and use of the device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough
Time Frame
one year
Secondary Outcome Measure Information:
Title
Incidence of respiratory complications
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony F DiMarco, MD
Organizational Affiliation
MetroHealth Medical Center and Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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Functional Electrical Stimulation for Production of Artificial Cough

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