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

NCT02200393 | Completed DMC

• 1 other identifier: GN11NE458
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Tetraplegia

Keywords

Spinal cord injury; Tetraplegia; Ventilator

Outcome Measures

Primary Outcomes (1)

• Time to wean from mechanical ventilation

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

  Assessed once per patient

Secondary Outcomes (4)

• Unassisted breathing vital capacity

  Up to 8 weeks

• AFES assisted breathing tidal volume

  Up to 8 weeks

• AFES assisted breathing vital capacity

  Up to 8 weeks

• Unassisted breathing tidal volume

  Up to 8 weeks

Study Arms (1)

Abdominal FES

EXPERIMENTAL

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.

Device: Abdominal FES

Interventions

Abdominal FES DEVICE

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.

Also known as: AFES, RehaStim

Abdominal FES

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23809523 BACKGROUND

• 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.

  PMID: 18776604 BACKGROUND

• 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.

  PMID: 17035064 BACKGROUND

• 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.

  PMID: 18533416 BACKGROUND

• 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.

  PMID: 26047468 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Henrik Gollee, PhD

  University of Glasgow

  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: Senior Lecturer

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 25, 2014
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

GB (1)