<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/NCT03019107</url>
  </required_header>
  <id_info>
    <org_study_id>LM-KINDRED-01</org_study_id>
    <nct_id>NCT03019107</nct_id>
  </id_info>
  <brief_title>Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study</brief_title>
  <official_title>Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liberate Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liberate Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine whether neuromuscular electrical&#xD;
      stimulation applied to the abdominal wall muscles in synchrony with exhalation can increase&#xD;
      the strength of the respiratory muscles in prolonged mechanical ventilation patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the U.S. over 500,000 patients have difficulty weaning from mechanical ventilation every&#xD;
      year. These patients cost the health care system $16 billion annually and have an increased&#xD;
      risk of medical complications and morbidity.&#xD;
&#xD;
      A major factor responsible for weaning failure is the imbalance between decreased respiratory&#xD;
      muscle strength and excessive respiratory load. This study includes an investigational device&#xD;
      that applies electrical stimulation to the abdominal muscles in synchrony with exhalation.&#xD;
      This is hypothesized to improve the strength of the respiratory muscles. The long term goal&#xD;
      of this project is to determine whether this approach can reduce the number of days taken for&#xD;
      patients to wean from mechanical ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to meet enrollment goal&#xD;
  </why_stopped>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">April 6, 2017</completion_date>
  <primary_completion_date type="Actual">April 6, 2017</primary_completion_date>
  <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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Maximum Expiratory Pressure From Baseline to Extubation</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Maximum expiratory pressure was measured from total lung capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximum Inspiratory Pressure From Baseline to Extubation</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Maximum inspiratory pressure was measured from end expiratory lung volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Thickness of transverse abdominis muscle as measured by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Thickness of the External Oblique Muscle From Baseline to Extubation</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Thickness of the external oblique muscle as measured by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Thickness of the internal oblique muscle as measured by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thickness of the Rectus Abdominis Muscle</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Thickness of the rectus abdominis muscle as measured by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thickness of the Diaphragm</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Thickness of the diaphragm as measured by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weaning Success</measure>
    <time_frame>The earlier of 6 weeks or first extubation, an expected average of 4 weeks</time_frame>
    <description>Defined as free from ventilator support for more than 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Taken to Wean</measure>
    <time_frame>The earlier of 6 weeks or first extubation, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cough Peak Flow From Baseline to Extubation</measure>
    <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
    <description>Cough peak flow was measured from total lung capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation</measure>
    <time_frame>Change from baseline to final study visit or first extubation, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit</measure>
    <time_frame>Change from baseline to final study visit, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit</measure>
    <time_frame>Change from baseline to final study visit, an expected average of 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Sensation of Stimulation Experienced by Patient</measure>
    <time_frame>Through study completion, an expected average of 4 weeks</time_frame>
    <description>Measured using the behavioral pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events That Are Related to Treatment</measure>
    <time_frame>Though study completion, an expected average of 4 weeks</time_frame>
    <description>This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Electric Stimulation</condition>
  <condition>Respiration, Artificial</condition>
  <condition>Ventilator Weaning</condition>
  <arm_group>
    <arm_group_label>VentFree Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breath synchronized abdominal NMES</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham breath synchronized abdominal NMES</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Breath synchronized abdominal NMES</intervention_name>
    <description>VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
    <arm_group_label>VentFree Stimulation</arm_group_label>
    <other_name>VentFree</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham breath synchronized abdominal NMES</intervention_name>
    <description>Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
    <arm_group_label>Sham Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have been mechanically ventilated for at least fourteen days.&#xD;
&#xD;
          -  Clinically stable: oxygen saturation &gt; 90% with a fractional inspired oxygen ≤ 0.40,&#xD;
             external positive end expiratory pressure ≤ 5 centimeters water, temperature ranging&#xD;
             from 35.5 to 38.5 degrees celsius, no intravenous administration of vasoactive agents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom Neuromuscular Electrical Stimulation (NMES) does not elicit a&#xD;
             palpable contraction of the abdominal muscles.&#xD;
&#xD;
          -  Patients with broken or irritated skin on the abdominal wall&#xD;
&#xD;
          -  Patients with a history of neuromuscular disease&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 35 kg/m2&#xD;
&#xD;
          -  Patients who are not medically stable&#xD;
&#xD;
          -  Patients with a pacemaker&#xD;
&#xD;
          -  Female patients who are pregnant&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients who are expected to die within four weeks&#xD;
&#xD;
          -  Patients who are unable to follow verbal instructions&#xD;
&#xD;
          -  Patients with epilepsy&#xD;
&#xD;
          -  Patients with an abdominal wall hernia&#xD;
&#xD;
          -  Patients with anoxic encephalopathy&#xD;
&#xD;
          -  Patients with history of, or active, substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kindred Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>September 2, 2021</results_first_submitted>
  <results_first_submitted_qc>October 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 8, 2021</results_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03019107/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VentFree Stimulation</title>
          <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
        </group>
        <group group_id="P2">
          <title>Sham Stimulation</title>
          <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No participants were enrolled in the control group as the trial was terminated after the first patient was enrolled.</population>
      <group_list>
        <group group_id="B1">
          <title>VentFree Stimulation</title>
          <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
        </group>
        <group group_id="B2">
          <title>Sham Stimulation</title>
          <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</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="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </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="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of mechanical ventilation at enrollment</title>
          <units>Days</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary reason for mechanical ventilation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Acute Respiratory Failure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Coma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>COPD</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asthma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neuromuscular Disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cause of acute respiratory failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pneumonia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Acute Physiology and Chronic Health Evaluation II (APACHE II) score</title>
          <description>The APACHE II score is a widely used ICU prognostic scale that is a measurement of patient disease severity and strongly correlates with patient outcomes.&#xD;
The APACHE II is an integer score from 0 to 71; higher scores correspond to more severe disease and a higher risk of death.</description>
          <units>units on a scale</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tracheostomized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Tracheostomized</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Tracheostomized</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Maximum Expiratory Pressure From Baseline to Extubation</title>
        <description>Maximum expiratory pressure was measured from total lung capacity</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>No patients were enrolled in the sham arm</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum Expiratory Pressure From Baseline to Extubation</title>
          <description>Maximum expiratory pressure was measured from total lung capacity</description>
          <population>No patients were enrolled in the sham arm</population>
          <units>cmH2O</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Maximum Inspiratory Pressure From Baseline to Extubation</title>
        <description>Maximum inspiratory pressure was measured from end expiratory lung volume.</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>No patients were enrolled in the sham arm</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Maximum Inspiratory Pressure From Baseline to Extubation</title>
          <description>Maximum inspiratory pressure was measured from end expiratory lung volume.</description>
          <population>No patients were enrolled in the sham arm</population>
          <units>cmH2O</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation</title>
        <description>Thickness of transverse abdominis muscle as measured by ultrasound</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>This measurement was not collected due to equipment problems.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation</title>
          <description>Thickness of transverse abdominis muscle as measured by ultrasound</description>
          <population>This measurement was not collected due to equipment problems.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Thickness of the External Oblique Muscle From Baseline to Extubation</title>
        <description>Thickness of the external oblique muscle as measured by ultrasound</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>This measurement was not collected due to equipment problems.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Thickness of the External Oblique Muscle From Baseline to Extubation</title>
          <description>Thickness of the external oblique muscle as measured by ultrasound</description>
          <population>This measurement was not collected due to equipment problems.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation</title>
        <description>Thickness of the internal oblique muscle as measured by ultrasound</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>This measurement was not collected due to equipment problems.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation</title>
          <description>Thickness of the internal oblique muscle as measured by ultrasound</description>
          <population>This measurement was not collected due to equipment problems.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Thickness of the Rectus Abdominis Muscle</title>
        <description>Thickness of the rectus abdominis muscle as measured by ultrasound</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>This measurement was not collected due to equipment problems.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Thickness of the Rectus Abdominis Muscle</title>
          <description>Thickness of the rectus abdominis muscle as measured by ultrasound</description>
          <population>This measurement was not collected due to equipment problems.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Thickness of the Diaphragm</title>
        <description>Thickness of the diaphragm as measured by ultrasound</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>This measurement was not collected due to equipment problems.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Thickness of the Diaphragm</title>
          <description>Thickness of the diaphragm as measured by ultrasound</description>
          <population>This measurement was not collected due to equipment problems.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weaning Success</title>
        <description>Defined as free from ventilator support for more than 72 hours</description>
        <time_frame>The earlier of 6 weeks or first extubation, an expected average of 4 weeks</time_frame>
        <population>No participants were enrolled in the sham group</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Weaning Success</title>
          <description>Defined as free from ventilator support for more than 72 hours</description>
          <population>No participants were enrolled in the sham group</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Taken to Wean</title>
        <time_frame>The earlier of 6 weeks or first extubation, an expected average of 4 weeks</time_frame>
        <population>No patients in the treatment group were successfully extubated from the ventilator. No patients were enrolled in the sham group</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Taken to Wean</title>
          <population>No patients in the treatment group were successfully extubated from the ventilator. No patients were enrolled in the sham group</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cough Peak Flow From Baseline to Extubation</title>
        <description>Cough peak flow was measured from total lung capacity</description>
        <time_frame>Change from baseline to first extubation, an expected average of 4 weeks</time_frame>
        <population>No participants were enrolled in the sham group</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cough Peak Flow From Baseline to Extubation</title>
          <description>Cough peak flow was measured from total lung capacity</description>
          <population>No participants were enrolled in the sham group</population>
          <units>Liters per minute</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation</title>
        <time_frame>Change from baseline to final study visit or first extubation, an expected average of 4 weeks</time_frame>
        <population>No participants were enrolled in the sham stimulation group.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation</title>
          <population>No participants were enrolled in the sham stimulation group.</population>
          <units>milliliters</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit</title>
        <time_frame>Change from baseline to final study visit, an expected average of 4 weeks</time_frame>
        <population>No participant were enrolled in the sham group</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit</title>
          <population>No participant were enrolled in the sham group</population>
          <units>breaths per minute</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit</title>
        <time_frame>Change from baseline to final study visit, an expected average of 4 weeks</time_frame>
        <population>No participants were enrolled in the sham group</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit</title>
          <population>No participants were enrolled in the sham group</population>
          <units>liters per minute</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Sensation of Stimulation Experienced by Patient</title>
        <description>Measured using the behavioral pain scale</description>
        <time_frame>Through study completion, an expected average of 4 weeks</time_frame>
        <population>This measurement was not recorded.</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Sensation of Stimulation Experienced by Patient</title>
          <description>Measured using the behavioral pain scale</description>
          <population>This measurement was not recorded.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Adverse Events That Are Related to Treatment</title>
        <description>This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.</description>
        <time_frame>Though study completion, an expected average of 4 weeks</time_frame>
        <population>No participants enrolled in sham group</population>
        <group_list>
          <group group_id="O1">
            <title>VentFree Stimulation</title>
            <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
          <group group_id="O2">
            <title>Sham Stimulation</title>
            <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events That Are Related to Treatment</title>
          <description>This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.</description>
          <population>No participants enrolled in sham group</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>Adverse events were reviewed during every study intervention session</desc>
      <group_list>
        <group group_id="E1">
          <title>VentFree Stimulation</title>
          <description>Breath synchronized abdominal NMES&#xD;
Breath synchronized abdominal NMES: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</description>
        </group>
        <group group_id="E2">
          <title>Sham Stimulation</title>
          <description>Sham breath synchronized abdominal NMES&#xD;
Sham breath synchronized abdominal NMES: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Mean arterial pressure</sub_title>
                <description>Mean arterial pressure was elevated to 128 mmHg prior to initiation of treatment. Adverse event was assessed with Moderate severity, no relationship with study device, and was resolved with no sequel.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal muscle soreness</sub_title>
                <description>Adverse event was rated with Mild severity and Definitely related to study intervention. Resolved with no sequel</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <description>Adverse event was assessed with Moderate severity and unrelated to study intervention. Resolved with no sequel.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" 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>Angus Mclachlan</name_or_title>
      <organization>Liberate Medical</organization>
      <phone>+1 (833) 203-4663</phone>
      <email>info@liberatemedical.com</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/NCT03019107
org study id: LM-KINDRED-01
nct id: NCT03019107
lead sponsor: 
has dmc: No
is unapproved device: Yes
The primary objective of this study is to determine whether neuromuscular electrical
      stimulation applied to the abdominal wall muscles in synchrony with exhalation can increase
      the strength of the respiratory muscles in prolonged mechanical ventilation patients.
In the U.S. over 500,000 patients have difficulty weaning from mechanical ventilation every
      year. These patients cost the health care system $16 billion annually and have an increased
      risk of medical complications and morbidity.

      A major factor responsible for weaning failure is the imbalance between decreased respiratory
      muscle strength and excessive respiratory load. This study includes an investigational device
      that applies electrical stimulation to the abdominal muscles in synchrony with exhalation.
      This is hypothesized to improve the strength of the respiratory muscles. The long term goal
      of this project is to determine whether this approach can reduce the number of days taken for
      patients to wean from mechanical ventilation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Maximum Expiratory Pressure From Baseline to Extubation
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Maximum expiratory pressure was measured from total lung capacity
measure: Change in Maximum Inspiratory Pressure From Baseline to Extubation
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Maximum inspiratory pressure was measured from end expiratory lung volume.
measure: Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Thickness of transverse abdominis muscle as measured by ultrasound
measure: Change in Thickness of the External Oblique Muscle From Baseline to Extubation
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Thickness of the external oblique muscle as measured by ultrasound
measure: Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Thickness of the internal oblique muscle as measured by ultrasound
measure: Thickness of the Rectus Abdominis Muscle
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Thickness of the rectus abdominis muscle as measured by ultrasound
measure: Thickness of the Diaphragm
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Thickness of the diaphragm as measured by ultrasound
measure: Weaning Success
time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
description: Defined as free from ventilator support for more than 72 hours
measure: Number of Days Taken to Wean
time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
measure: Change in Cough Peak Flow From Baseline to Extubation
time frame: Change from baseline to first extubation, an expected average of 4 weeks
description: Cough peak flow was measured from total lung capacity
measure: Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation
time frame: Change from baseline to final study visit or first extubation, an expected average of 4 weeks
measure: Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit
time frame: Change from baseline to final study visit, an expected average of 4 weeks
measure: Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit
time frame: Change from baseline to final study visit, an expected average of 4 weeks
measure: Maximum Sensation of Stimulation Experienced by Patient
time frame: Through study completion, an expected average of 4 weeks
description: Measured using the behavioral pain scale
measure: Number of Adverse Events That Are Related to Treatment
time frame: Though study completion, an expected average of 4 weeks
description: This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.
arm group label: VentFree Stimulation
arm group type: Experimental
description: Breath synchronized abdominal NMES
arm group label: Sham Stimulation
arm group type: Sham Comparator
description: Sham breath synchronized abdominal NMES
intervention type: Device
intervention name: Breath synchronized abdominal NMES
description: VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.
arm group label: VentFree Stimulation
other name: VentFree
intervention type: Device
intervention name: Sham breath synchronized abdominal NMES
description: Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.
arm group label: Sham Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 