<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02200393</url>
  </required_header>
  <id_info>
    <org_study_id>GN11NE458</org_study_id>
    <nct_id>NCT02200393</nct_id>
  </id_info>
  <brief_title>Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia</brief_title>
  <official_title>Feasibility Study Using Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Glasgow</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compromised respiratory function as a result of tetraplegia leads to many tetraplegics&#xD;
      requiring mechanical ventilation during the acute phase of injury. Mechanical ventilation is&#xD;
      associated with additional costs to the local health care provider and reduced quality of&#xD;
      life of the patient. Electrical stimulation of the abdominal muscles has previously been used&#xD;
      to improve the respiratory function of tetraplegic patients in the chronic stage of injury.&#xD;
      In this study the investigators aim to evaluate whether electrical stimulation of the&#xD;
      abdominal muscles can assist the process of weaning from mechanical ventilation in acute&#xD;
      ventilator dependent spinal cord injured patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      The principal aim of this study is to evaluate the feasibility of using Abdominal Functional&#xD;
      Electrical Stimulation (AFES) to assist weaning from mechanical ventilator in acute&#xD;
      ventilator dependent tetraplegic subjects.&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      10 ventilator dependent tetraplegic participants in the acute stage of injury will be&#xD;
      recruited while inpatients at the Queen Elizabeth National Spinal Injuries Unit (QENSIU),&#xD;
      Southern General Hospital, Glasgow. The participants will be matched for injury level, age&#xD;
      (+/5 years) and sex with a control obtained from historic records of previous patients in the&#xD;
      QENSIU.&#xD;
&#xD;
      Experimental Procedures:&#xD;
&#xD;
      Each participant will take part in daily AFES-assisted Weaning sessions (5 times per week)&#xD;
      during alternative weeks. Progress will be monitored during weekly Assessment sessions. The&#xD;
      total duration of participation is 8 weeks.&#xD;
&#xD;
      AFES-assisted Weaning sessions:&#xD;
&#xD;
      The aim of the weaning sessions is to strengthen the abdominal muscles and to provide support&#xD;
      for ventilator free breathing.&#xD;
&#xD;
      The participant will receive AFES training once per day for a predetermined time (see below),&#xD;
      5 days per week. Before the study begins and at the end of each week an assessment session&#xD;
      will be conducted.&#xD;
&#xD;
      AFES training sessions will continue throughout even if the patient is successfully weaned&#xD;
      before the end of the 8 week period. All procedures will be carried out at the participant's&#xD;
      bedside and during all procedures a clinician and the participant's nurse will be present.&#xD;
&#xD;
      The duration of AFES training will initially be 20 minutes/day. This will be increased to 30&#xD;
      minutes in week 3 and to 40 minutes during weeks 5 and 7. While the participant is still not&#xD;
      able to breathe independently of the ventilator, AFES will be applied while the participant&#xD;
      is connected to the ventilator. As weaning progresses, Spontaneous Breathing Trials (SBTs)&#xD;
      will begin and AFES will be applied with the participant disconnected from the ventilator.&#xD;
      While the participant is off the ventilator their oxygen saturation level (SaPO2) will be&#xD;
      monitored and recorded every minute. Participant will be immediately reconnected to the&#xD;
      ventilator if their SaPO2 falls below a clinically critical value of 92%.&#xD;
&#xD;
      Assessment sessions:&#xD;
&#xD;
      An initial assessment session will be conducted on day 1 of the study to provide a baseline&#xD;
      measure of the participant's respiratory function. Assessment sessions will then be conducted&#xD;
      once per week to assess weaning progress. The assessment sessions will be augmented with a&#xD;
      period of AFES training to ensure that the prescribed period of AFES is achieved (see above).&#xD;
&#xD;
      During the assessment sessions the participant's respiratory function (Secondary Outcome&#xD;
      Measures) will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to wean from mechanical ventilation</measure>
    <time_frame>Assessed once per patient</time_frame>
    <description>Time from initial ventilation to achieve 7 days of ventilator free breathing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unassisted breathing vital capacity</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The participant will be asked to breathe without ventilator support. Vital capacity (total lung capacity, VC) will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AFES assisted breathing tidal volume</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AFES assisted breathing vital capacity</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unassisted breathing tidal volume</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Tetraplegia</condition>
  <arm_group>
    <arm_group_label>Abdominal FES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Abdominal FES</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Abdominal FES</arm_group_label>
    <other_name>AFES</other_name>
    <other_name>RehaStim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute spinal cord injured tetraplegic patients (patients with a new spinal cord&#xD;
             injury) who are inpatients at the Queen Elizabeth National Spinal Injuries Unit&#xD;
             (QENSIU), Southern General Hospital, Glasgow;&#xD;
&#xD;
          -  Reduced respiratory function requiring mechanical ventilation;&#xD;
&#xD;
          -  Good visual response to surface abdominal stimulation, suggesting that lower motor&#xD;
             neurons are intact.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subjects who are pregnant;&#xD;
&#xD;
          -  Significant history of autonomic dysreflexia;&#xD;
&#xD;
          -  No visual response to surface abdominal stimulation, suggesting that lower motor&#xD;
             neurons are not intact.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik Gollee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth National Spinal Injuries Unit</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>23809523</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18776604</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17035064</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18533416</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Henrik Gollee</investigator_full_name>
    <investigator_title>Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>Spinal cord injury</keyword>
  <keyword>Tetraplegia</keyword>
  <keyword>Ventilator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Quadriplegia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02200393
org study id: GN11NE458
nct id: NCT02200393
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to wean from mechanical ventilation
time frame: Assessed once per patient
description: Time from initial ventilation to achieve 7 days of ventilator free breathing.
measure: Unassisted breathing vital capacity
time frame: Up to 8 weeks
description: The participant will be asked to breathe without ventilator support. Vital capacity (total lung capacity, VC) will be measured.
measure: AFES assisted breathing tidal volume
time frame: Up to 8 weeks
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.
measure: AFES assisted breathing vital capacity
time frame: Up to 8 weeks
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.
measure: Unassisted breathing tidal volume
time frame: Up to 8 weeks
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.
arm group label: Abdominal FES
arm group type: Experimental
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: Abdominal FES
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.
arm group label: Abdominal FES
other name: AFES
other name: RehaStim
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Henrik Gollee, PhD
role: Principal Investigator
affiliation: University of Glasgow
facility: 
country: United Kingdom
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.
PMID: 23809523
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.
PMID: 18776604
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.
PMID: 17035064
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.
PMID: 18533416
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Henrik Gollee
investigator title: Senior Lecturer
mesh term: Spinal Cord Injuries
mesh term: Quadriplegia