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Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia

NCT02200393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-25

No results posted yet for this study

Summary

Compromised respiratory function as a result of tetraplegia leads to many tetraplegics requiring mechanical ventilation during the acute phase of injury. Mechanical ventilation is associated with additional costs to the local health care provider and reduced quality of life of the patient. Electrical stimulation of the abdominal muscles has previously been used to improve the respiratory function of tetraplegic patients in the chronic stage of injury. In this study the investigators aim to evaluate whether electrical stimulation of the abdominal muscles can assist the process of weaning from mechanical ventilation in acute ventilator dependent spinal cord injured patients.

Conditions

  • Spinal Cord Injury
  • Tetraplegia

Interventions

DEVICE

Abdominal FES

Stimulation intensity was adjusted on a channel by channel basis until a strong visible contraction of the abdominal muscles is observed. During the session, manual adjustment of both the stimulation intensity (to compensate for fatigue) and the duty cycle is possible. Four pairs of surface electrodes were placed on the participant's abdomen. One pair will be placed on both the right and left side of the rectus abdominis around the naval. One pair of electrodes will also be placed on both the right and left side of the external oblique muscles with one electrode being placed just below the participant's bottom rib and the other below this with a separation of around 3cm.

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • University of Glasgow

    lead OTHER

Principal Investigators

  • Henrik Gollee, PhD · University of Glasgow

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200393 on ClinicalTrials.gov