<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/NCT02204215</url>
  </required_header>
  <id_info>
    <org_study_id>EA-ICUAW</org_study_id>
    <nct_id>NCT02204215</nct_id>
  </id_info>
  <brief_title>Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients</brief_title>
  <acronym>EA-ICUAW</acronym>
  <official_title>Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Province Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Province Hospital of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery.&#xD;
      The purpose of this study is to determine whether electric acupuncture therapy is effective&#xD;
      in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with&#xD;
      sepsis or multiorgan system failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principle of acupuncture is to produce bioelectric current, as a consequence, to&#xD;
      invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune&#xD;
      function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints,&#xD;
      out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle&#xD;
      recovery and regeneration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>strength related parameters</measure>
    <time_frame>Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks</time_frame>
    <description>muscle force, arm circumference, skin fold thickness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mechanical ventilation duration</measure>
    <time_frame>Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks</time_frame>
    <description>the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>Participants will be followed until the 28th day after mechanical ventilation</time_frame>
    <description>the mortality till the 28th day after mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with adverse events of electric acupuncture</measure>
    <time_frame>Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks</time_frame>
    <description>the adverse enents include fainting, infection, bleeding, viscera damage, and so on.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU duration</measure>
    <time_frame>Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks</time_frame>
    <description>the time span from the beginning of mechanical ventilation, till the date of discharge from the ICU</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Sepsis</condition>
  <condition>Multiple Organ Dysfunction Syndrome</condition>
  <arm_group>
    <arm_group_label>electric acupuncture &amp; conservative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electric acupuncture</intervention_name>
    <description>Electric acupuncture therapy was made on LI4, LI11, ST36, and ST41 on four limbs for each patient, 30 min for each time, twice per day. Starting from the beginning of mechanical ventilation, to the weaning of the mechanical ventilation.</description>
    <arm_group_label>electric acupuncture &amp; conservative</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conservative</intervention_name>
    <description>General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.</description>
    <arm_group_label>electric acupuncture &amp; conservative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of sepsis or multiple organ dysfunction syndrome&#xD;
&#xD;
          -  Within 48 hours from the initiation of mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Neuromuscular disease or cerebrovascular accident&#xD;
&#xD;
          -  With temporary or permanent pacemaker&#xD;
&#xD;
          -  Need to use neuromuscular blocking agents&#xD;
&#xD;
          -  Inactivity for more than 5 days before ICU admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xing Wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of Intensive Care Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Intensive Care Unit, Jiangsu Province Hospital of TCM</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jiangsu Province Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Wangxing</investigator_full_name>
    <investigator_title>Director of Intensive Care Unit</investigator_title>
  </responsible_party>
  <keyword>Weakness</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Acupuncture Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Asthenia</mesh_term>
    <mesh_term>Multiple Organ Failure</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/NCT02204215
org study id: EA-ICUAW
nct id: NCT02204215
lead sponsor: 
has dmc: Yes
Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery.
      The purpose of this study is to determine whether electric acupuncture therapy is effective
      in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with
      sepsis or multiorgan system failure.
The principle of acupuncture is to produce bioelectric current, as a consequence, to
      invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune
      function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints,
      out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle
      recovery and regeneration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: strength related parameters
time frame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
description: muscle force, arm circumference, skin fold thickness
measure: mechanical ventilation duration
time frame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
description: the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation
measure: 28-day mortality
time frame: Participants will be followed until the 28th day after mechanical ventilation
description: the mortality till the 28th day after mechanical ventilation
measure: number of participants with adverse events of electric acupuncture
time frame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
description: the adverse enents include fainting, infection, bleeding, viscera damage, and so on.
measure: ICU duration
time frame: Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks
description: the time span from the beginning of mechanical ventilation, till the date of discharge from the ICU
arm group label: electric acupuncture & conservative
arm group type: Experimental
description: Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture.
intervention type: Device
intervention name: electric acupuncture
description: Electric acupuncture therapy was made on LI4, LI11, ST36, and ST41 on four limbs for each patient, 30 min for each time, twice per day. Starting from the beginning of mechanical ventilation, to the weaning of the mechanical ventilation.
arm group label: electric acupuncture & conservative
intervention type: Other
intervention name: conservative
description: General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.
arm group label: electric acupuncture & conservative
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xing Wang, M.D.
role: Principal Investigator
affiliation: Director of Intensive Care Unit
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine
investigator full name: Wangxing
investigator title: Director of Intensive Care Unit
mesh term: Sepsis
mesh term: Respiratory Insufficiency
mesh term: Syndrome
mesh term: Asthenia
mesh term: Multiple Organ Failure