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

Primary Purpose

Spinal Cord Injury, Tetraplegia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Abdominal FES
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Tetraplegia, Ventilator

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute spinal cord injured tetraplegic patients (patients with a new spinal cord injury) who are inpatients at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Southern General Hospital, Glasgow;
  • Reduced respiratory function requiring mechanical ventilation;
  • Good visual response to surface abdominal stimulation, suggesting that lower motor neurons are intact.

Exclusion Criteria:

  • Female subjects who are pregnant;
  • Significant history of autonomic dysreflexia;
  • No visual response to surface abdominal stimulation, suggesting that lower motor neurons are not intact.

Sites / Locations

  • Queen Elizabeth National Spinal Injuries Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abdominal FES

Arm Description

Participants in the Abdominal Functional Electrical Stimulation (AFES) group will receive AFES 5 times per week (20 to 40 mins per day), on four alternate weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Unassisted breathing vital capacity
The participant will be asked to breathe without ventilator support. Vital capacity (total lung capacity, VC) will be measured.
AFES assisted breathing tidal volume
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
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
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.

Full Information

First Posted
July 22, 2014
Last Updated
July 24, 2014
Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT02200393
Brief Title
Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia
Official Title
Feasibility Study Using Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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. The duration of AFES training will initially be 20 minutes/day. This will be increased to 30 minutes in week 3 and to 40 minutes during weeks 5 and 7. While the participant is still not able to breathe independently of the ventilator, AFES will be applied while the participant is connected to the ventilator. As weaning progresses, Spontaneous Breathing Trials (SBTs) will begin and AFES will be applied with the participant disconnected from the ventilator. While the participant is off the ventilator their oxygen saturation level (SaPO2) will be monitored and recorded every minute. Participant will be immediately reconnected to the ventilator if their SaPO2 falls below a clinically critical value of 92%. Assessment sessions: An initial assessment session will be conducted on day 1 of the study to provide a baseline measure of the participant's respiratory function. Assessment sessions will then be conducted once per week to assess weaning progress. The assessment sessions will be augmented with a period of AFES training to ensure that the prescribed period of AFES is achieved (see above). During the assessment sessions the participant's respiratory function (Secondary Outcome Measures) will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Tetraplegia
Keywords
Spinal cord injury, Tetraplegia, Ventilator

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Abdominal FES
Arm Type
Experimental
Arm Description
Participants in the Abdominal Functional Electrical Stimulation (AFES) group will receive AFES 5 times per week (20 to 40 mins per day), on four alternate weeks.
Intervention Type
Device
Intervention Name(s)
Abdominal FES
Other Intervention Name(s)
AFES, RehaStim
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to wean from mechanical ventilation
Description
Time from initial ventilation to achieve 7 days of ventilator free breathing.
Time Frame
Assessed once per patient
Secondary Outcome Measure Information:
Title
Unassisted breathing vital capacity
Description
The participant will be asked to breathe without ventilator support. Vital capacity (total lung capacity, VC) will be measured.
Time Frame
Up to 8 weeks
Title
AFES assisted breathing tidal volume
Description
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.
Time Frame
Up to 8 weeks
Title
AFES assisted breathing vital capacity
Description
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.
Time Frame
Up to 8 weeks
Title
Unassisted breathing tidal volume
Description
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.
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute spinal cord injured tetraplegic patients (patients with a new spinal cord injury) who are inpatients at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Southern General Hospital, Glasgow; Reduced respiratory function requiring mechanical ventilation; Good visual response to surface abdominal stimulation, suggesting that lower motor neurons are intact. Exclusion Criteria: Female subjects who are pregnant; Significant history of autonomic dysreflexia; No visual response to surface abdominal stimulation, suggesting that lower motor neurons are not intact.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Gollee, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23809523
Citation
McLachlan AJ, McLean AN, Allan DB, Gollee H. Changes in pulmonary function measures following a passive abdominal functional electrical stimulation training program. J Spinal Cord Med. 2013 Mar;36(2):97-103. doi: 10.1179/2045772312Y.0000000031.
Results Reference
background
PubMed Identifier
18776604
Citation
Gollee H, Hunt KJ, Allan DB, Fraser MH, McLean AN. Automatic electrical stimulation of abdominal wall muscles increases tidal volume and cough peak flow in tetraplegia. Technol Health Care. 2008;16(4):273-81.
Results Reference
background
PubMed Identifier
17035064
Citation
Gollee H, Hunt KJ, Allan DB, Fraser MH, McLean AN. A control system for automatic electrical stimulation of abdominal muscles to assist respiratory function in tetraplegia. Med Eng Phys. 2007 Sep;29(7):799-807. doi: 10.1016/j.medengphy.2006.08.007. Epub 2006 Oct 10.
Results Reference
background
PubMed Identifier
18533416
Citation
Lee BB, Boswell-Ruys C, Butler JE, Gandevia SC. Surface functional electrical stimulation of the abdominal muscles to enhance cough and assist tracheostomy decannulation after high-level spinal cord injury. J Spinal Cord Med. 2008;31(1):78-82. doi: 10.1080/10790268.2008.11753985.
Results Reference
background
PubMed Identifier
26047468
Citation
McCaughey EJ, Berry HR, McLean AN, Allan DB, Gollee H. Abdominal Functional Electrical Stimulation to Assist Ventilator Weaning in Acute Tetraplegia: A Cohort Study. PLoS One. 2015 Jun 5;10(6):e0128589. doi: 10.1371/journal.pone.0128589. eCollection 2015.
Results Reference
derived

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

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