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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility Study Using Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia

Brief 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.

Detailed Summary:

Purpose:

The principal aim of this study is to evaluate the feasibility of using Abdominal Functional Electrical Stimulation (AFES) to assist weaning from mechanical ventilator in acute ventilator dependent tetraplegic subjects.

Participants:

10 ventilator dependent tetraplegic participants in the acute stage of injury will be recruited while inpatients at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Southern General Hospital, Glasgow. The participants will be matched for injury level, age (+/5 years) and sex with a control obtained from historic records of previous patients in the QENSIU.

Experimental Procedures:

Each participant will take part in daily AFES-assisted Weaning sessions (5 times per week) during alternative weeks. Progress will be monitored during weekly Assessment sessions. The total duration of participation is 8 weeks.

AFES-assisted Weaning sessions:

The aim of the weaning sessions is to strengthen the abdominal muscles and to provide support for ventilator free breathing.

The participant will receive AFES training once per day for a predetermined time (see below), 5 days per week. Before the study begins and at the end of each week an assessment session will be conducted.

AFES training sessions will continue throughout even if the patient is successfully weaned before the end of the 8 week period. All procedures will be carried out at the participant's bedside and during all procedures a clinician and the participant's nurse will be present.


Sponsor: University of Glasgow

Current Primary Outcome: Time to wean from mechanical ventilation [ Time Frame: Assessed once per patient ]

Time from initial ventilation to achieve 7 days of ventilator free breathing.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Unassisted breathing vital capacity [ Time Frame: Up to 8 weeks ]
    The participant will be asked to breathe without ventilator support. Vital capacity (total lung capacity, VC) will be measured.
  • AFES assisted breathing tidal volume [ Time Frame: Up to 8 weeks ]
    The participant will be asked to breathe on their own without the support of the ventilator, but with the assistance of abdominal FES. During this time tidal volume will be recorded.
  • AFES assisted breathing vital capacity [ Time Frame: Up to 8 weeks ]
    The participant will be asked to breathe on their own without the support of the ventilator, but with the assistance of abdominal FES. During this time vital capacity will be recorded.
  • Unassisted breathing tidal volume [ Time Frame: Up to 8 weeks ]
    The participant will be asked to breathe without ventilator support. Tidal volume (amount of air inhaled and exhaled during a breath, VT) will be measured.


Original Secondary Outcome: Same as current

Information By: University of Glasgow

Dates:
Date Received: July 22, 2014
Date Started: February 2011
Date Completion:
Last Updated: July 24, 2014
Last Verified: July 2014