<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/NCT02227810</url>
  </required_header>
  <id_info>
    <org_study_id>103-1702C</org_study_id>
    <nct_id>NCT02227810</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation in Patients With Prolonged Mechanical Ventilation</brief_title>
  <official_title>Effects of Muscular Electrical Stimulation on Skeletal and Lung Mechanics in Patients With Prolonged Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong&#xD;
      mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days&#xD;
      of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients&#xD;
      with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of&#xD;
      this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics&#xD;
      and hospitalization outcomes in patients with PMV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND AND PURPOSE: Muscle atrophy and diaphragm dysfunction are common complication in&#xD;
      patients with prolong mechanical ventilator (PMV) and is associated with increased rate of&#xD;
      weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be&#xD;
      beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary&#xD;
      disease. The purpose of this study is to examine the effects of ES on skeletal muscle&#xD;
      function, pulmonary mechanics and hospitalization outcomes in patients with PMV.&#xD;
&#xD;
      METHODS: Patients who have been on mechanical ventilator for more than 21 days will be&#xD;
      recruited from respiratory care center (RCC). All subjects will be randomly assigned into&#xD;
      three groups: ES in abdominal muscles (ES-Abd, n=30),ES in brachial biceps (ES-bicep, n=30)&#xD;
      and sham group(Sham). Subjects in both groups will receive ES in muscles for 30 min/session,&#xD;
      2 sessions/day for 10 days with the same setting except area of ES. The muscle function will&#xD;
      be assessed by skin-fold thickness and muscle strength. The pulmonary function will be&#xD;
      assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal&#xD;
      inspiratory pressure. The hospitalization outcome will be followed up until patients are&#xD;
      discharged from RCC. The outcomes variables include: weaning rate and duration, mortality,&#xD;
      days of ventilator, and length of RCC stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of Activity of Daily Life</measure>
    <time_frame>end of intervention</time_frame>
    <description>The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>end of intervention</time_frame>
    <description>The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary Function</measure>
    <time_frame>end of intervention</time_frame>
    <description>The pulmonary function as assessed by the measurement of tidal volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization Outcomes</measure>
    <time_frame>the day participants were discharged from RCC</time_frame>
    <description>The total days that participants stay in the respiratory care center (RCC).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electrical stimulation (high frequency)</intervention_name>
    <description>Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days</description>
    <arm_group_label>electrical stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electrical stimulation (low frequency)</intervention_name>
    <description>Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.</description>
    <arm_group_label>electrical stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham group</intervention_name>
    <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
    <arm_group_label>sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt;20 years old&#xD;
&#xD;
          -  mechanical ventilation for more than 6 h/ day for more than 21 days -- medical&#xD;
             stability (arterial blood gas value hydrogen power(pH): 7.35-7.45, atrial oxygen&#xD;
             pressure(PaO2): 60 mmHg at 40% fraction of inspired oxygen inspired oxygen fraction&#xD;
             (FiO2), absence of signs and symptoms of infection, and hemodynamic stability);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  signs of acute infection (BT&gt;38.5℃，WBC&gt;12000 or &lt;3000 per unit&#xD;
&#xD;
          -  neuromuscular disease at acute stage&#xD;
&#xD;
          -  diagnosis of cancer at end-stage&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  BMI&gt;35kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chung-Chi Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Tao-Yuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>August 15, 2016</results_first_submitted>
  <results_first_submitted_qc>February 7, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 27, 2017</results_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prolong mechanical ventilator,</keyword>
  <keyword>Electrical stimulation,</keyword>
  <keyword>Activities of daily life,</keyword>
  <keyword>Hospitalization outcomes.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: 2012/08/01--2014/07/31 Location: respiratory care center</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Sham Group</title>
          <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.&#xD;
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
        </group>
        <group group_id="P2">
          <title>Electrical Stimulation</title>
          <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Electrical Stimulation</title>
          <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.</description>
        </group>
        <group group_id="B2">
          <title>Sham Group</title>
          <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.&#xD;
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.2" spread="15.4"/>
                    <measurement group_id="B2" value="71.9" spread="17.8"/>
                    <measurement group_id="B3" value="74.5" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Level of Activity of Daily Life</title>
        <description>The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).</description>
        <time_frame>end of intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham Group</title>
            <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.&#xD;
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
          </group>
          <group group_id="O2">
            <title>Electrical Stimulation</title>
            <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Activity of Daily Life</title>
          <description>The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" spread="14.5"/>
                    <measurement group_id="O2" value="32.0" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.652</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.123</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Muscle Strength</title>
        <description>The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.</description>
        <time_frame>end of intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham Group</title>
            <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.&#xD;
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
          </group>
          <group group_id="O2">
            <title>Electrical Stimulation</title>
            <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Muscle Strength</title>
          <description>The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.1"/>
                    <measurement group_id="O2" value="2.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.051</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulmonary Function</title>
        <description>The pulmonary function as assessed by the measurement of tidal volume.</description>
        <time_frame>end of intervention</time_frame>
        <population>t -test</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Group</title>
            <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
          </group>
          <group group_id="O2">
            <title>Electrical Stimulation</title>
            <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days</description>
          </group>
        </group_list>
        <measure>
          <title>Pulmonary Function</title>
          <description>The pulmonary function as assessed by the measurement of tidal volume.</description>
          <population>t -test</population>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.7" spread="102.7"/>
                    <measurement group_id="O2" value="214.4" spread="57.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.051</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization Outcomes</title>
        <description>The total days that participants stay in the respiratory care center (RCC).</description>
        <time_frame>the day participants were discharged from RCC</time_frame>
        <population>t test</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Group</title>
            <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.&#xD;
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
          </group>
          <group group_id="O2">
            <title>Electrical Stimulation</title>
            <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days&#xD;
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization Outcomes</title>
          <description>The total days that participants stay in the respiratory care center (RCC).</description>
          <population>t test</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" spread="18.2"/>
                    <measurement group_id="O2" value="32.3" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.792</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse Events were no collected /assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sham Group</title>
          <description>Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.</description>
        </group>
        <group group_id="E2">
          <title>Electrical Stimulation</title>
          <description>Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Huang Chung-Chi</name_or_title>
      <organization>Chang Gung memorial hospital</organization>
      <phone>88632118800 ext 5233</phone>
      <email>yhchen@mail.cgu.edu.tw</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02227810
org study id: 103-1702C
nct id: NCT02227810
lead sponsor: 
has dmc: Yes
Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong
      mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days
      of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients
      with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of
      this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics
      and hospitalization outcomes in patients with PMV.
BACKGROUND AND PURPOSE: Muscle atrophy and diaphragm dysfunction are common complication in
      patients with prolong mechanical ventilator (PMV) and is associated with increased rate of
      weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be
      beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary
      disease. The purpose of this study is to examine the effects of ES on skeletal muscle
      function, pulmonary mechanics and hospitalization outcomes in patients with PMV.

      METHODS: Patients who have been on mechanical ventilator for more than 21 days will be
      recruited from respiratory care center (RCC). All subjects will be randomly assigned into
      three groups: ES in abdominal muscles (ES-Abd, n=30),ES in brachial biceps (ES-bicep, n=30)
      and sham group(Sham). Subjects in both groups will receive ES in muscles for 30 min/session,
      2 sessions/day for 10 days with the same setting except area of ES. The muscle function will
      be assessed by skin-fold thickness and muscle strength. The pulmonary function will be
      assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal
      inspiratory pressure. The hospitalization outcome will be followed up until patients are
      discharged from RCC. The outcomes variables include: weaning rate and duration, mortality,
      days of ventilator, and length of RCC stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Level of Activity of Daily Life
time frame: end of intervention
description: The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).
measure: Muscle Strength
time frame: end of intervention
description: The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.
measure: Pulmonary Function
time frame: end of intervention
description: The pulmonary function as assessed by the measurement of tidal volume.
measure: Hospitalization Outcomes
time frame: the day participants were discharged from RCC
description: The total days that participants stay in the respiratory care center (RCC).
arm group label: electrical stimulation
arm group type: Experimental
description: Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
arm group label: sham group
arm group type: Sham Comparator
description: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
intervention type: Other
intervention name: electrical stimulation (high frequency)
description: Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
arm group label: electrical stimulation
intervention type: Other
intervention name: electrical stimulation (low frequency)
description: Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.
arm group label: electrical stimulation
intervention type: Other
intervention name: sham group
description: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
arm group label: sham group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Chung-Chi Huang
role: Principal Investigator
affiliation: Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 