Spinal Cord InjuryNCT02200393
Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia
A study testing Abdominal FES in people with Spinal Cord Injury and Tetraplegia, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia
- What is being tested?
- Abdominal FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow, G51 4TF
About this study
Official title: Feasibility Study Using Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Tetraplegia
- Being tested
- Abdominal FES
- Keywords
- Spinal cord injury, Tetraplegia, Ventilator
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal FESDevice
Also called AFES, RehaStim
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Abdominal FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wean from mechanical ventilation
Time from initial ventilation to achieve 7 days of ventilator free breathing.
Measured: Assessed once per patient
Secondary outcomes (4)
Unassisted breathing vital capacity
The participant will be asked to breathe without ventilator support. Vital capacity (total lung capacity, VC) will be measured.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Henrik Gollee, University of Glasgow
- Investigators
- Henrik Gollee, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200393
- Sponsor's protocol ID
- GN11NE458
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23809523Gollee 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.
PubMed 18776604Gollee 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.
PubMed 17035064Lee 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.
PubMed 18533416McCaughey 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.
PubMed 26047468
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Using Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia
- ClinicalTrials.gov ID
- NCT02200393
- Acronym / sponsor ID
- GN11NE458
- Conditions
- Spinal Cord Injury, Tetraplegia
- Keywords
- Spinal cord injury, Tetraplegia, Ventilator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal FES | Experimental | Device: Abdominal FESParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal FESAlso: AFES, RehaStimStimulation 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. | Device | Abdominal FES |
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.
4 secondary outcomes
Unassisted breathing vital capacity
Time frame: Up to 8 weeks
AFES assisted breathing tidal volume
Time frame: Up to 8 weeks
AFES assisted breathing vital capacity
Time frame: Up to 8 weeks
Unassisted breathing tidal volume
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Background: PubMed 23809523McLachlan 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.
- Background: PubMed 18776604Gollee 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.
- Background: PubMed 17035064Gollee 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.
- Background: PubMed 18533416Lee 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.
- Derived from this study: PubMed 26047468McCaughey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Gollee, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal FES in people with Spinal Cord Injury and Tetraplegia, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wean from mechanical ventilation (time frame: Assessed once per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02200393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.