<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/NCT01680783</url>
  </required_header>
  <id_info>
    <org_study_id>12-1391</org_study_id>
    <nct_id>NCT01680783</nct_id>
  </id_info>
  <brief_title>Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure</brief_title>
  <official_title>Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study is to evaluate the efficacy of helmet ventilation as compared with&#xD;
      Face mask in patients with respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Respiratory failure is often treated with endotracheal intubation and mechanical ventilation.&#xD;
      Although, the institution of mechanical ventilation is considered life saving, the associated&#xD;
      complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and&#xD;
      neuromuscular weakness are not without considerable morbidity and mortality.&#xD;
&#xD;
      Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic&#xD;
      respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory&#xD;
      failure in immunocompromised patients.&#xD;
&#xD;
      Despite the advantages of non-invasive ventilation via facemask, some patients fail because&#xD;
      of mask intolerance and severity of disease. Further limitation to facemask non-invasive&#xD;
      ventilation is that the seal integrity is lost when higher pressures are required.&#xD;
      Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock&#xD;
      may require such higher pressures.&#xD;
&#xD;
      In an attempt to improve patient tolerability and deliver higher pressures, a transparent&#xD;
      helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the&#xD;
      entire head and neck of the patient. The design of the helmet confers some important&#xD;
      advantages: 1) the transparency allows the patient to interact with the environment; 2) the&#xD;
      lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems&#xD;
      of leaking with higher airway pressures that are seen with the face mask; 4) it can be&#xD;
      applied to any patient regardless of facial contour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need for Endotracheal Intubation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of patients requiring endotracheal intubation after application of helmet device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Duration of hospital stay</time_frame>
    <description>Days spent in hospital at time of enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Functional Status After Discharge</measure>
    <time_frame>Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)</time_frame>
    <description>Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free Days</measure>
    <time_frame>number of days in the hospital</time_frame>
    <description>Duration of mechanical ventilation via endotracheal tube</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Death from any cause during hospitalization at time of enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit Length of Stay</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of days admitted to a medical intensive care unit</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ICU Complications</measure>
    <time_frame>6 weeks</time_frame>
    <description>ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness</description>
  </other_outcome>
  <other_outcome>
    <measure>Readmission to the Intensive Care Unit</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment</description>
  </other_outcome>
  <other_outcome>
    <measure>Discharge Location</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to</description>
  </other_outcome>
  <other_outcome>
    <measure>Improvement of Oxygenation</measure>
    <time_frame>2 weeks</time_frame>
    <description>Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Shock</condition>
  <condition>Ventilatory Failure</condition>
  <condition>Cardiogenic Pulmonary Edema</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non invasive ventilation via helmet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non invasive ventilation using a helmet hyperbaric device</intervention_name>
    <description>Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
    <arm_group_label>Non invasive ventilation via helmet</arm_group_label>
    <other_name>Sea-Long medical treatment hood</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Noninvasive ventilation via facemask</intervention_name>
    <description>Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
    <arm_group_label>Usual Care</arm_group_label>
    <other_name>mechanical ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years of age who require noninvasive ventilation via facemask for&#xD;
             &gt;8hours&#xD;
&#xD;
          -  Intact airway protective gag reflex&#xD;
&#xD;
          -  Able to follow instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiopulmonary arrest&#xD;
&#xD;
          -  Glasgow coma scale &lt;8&#xD;
&#xD;
          -  Absence of airway protective gag reflex&#xD;
&#xD;
          -  Elevated intracranial pressure&#xD;
&#xD;
          -  Tracheostomy&#xD;
&#xD;
          -  Upper airway obstruction&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patients who refuse to undergo endotracheal intubation, whatever the initial&#xD;
             therapeutic approach&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John P Kress, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>October 27, 2016</results_first_submitted>
  <results_first_submitted_qc>May 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2017</results_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>noninvasive ventilation</keyword>
  <keyword>acute hypoxemic respiratory failure</keyword>
  <keyword>Acute respiratory distress syndrome</keyword>
  <keyword>shock</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Hypoventilation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
        </group>
        <group group_id="P2">
          <title>Non Invasive Ventilation Via Helmet</title>
          <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="44"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
        </group>
        <group group_id="B2">
          <title>Non Invasive Ventilation Via Helmet</title>
          <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</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="39"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="83"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.9" lower_limit="56.4" upper_limit="71.1"/>
                    <measurement group_id="B2" value="58" lower_limit="49.8" upper_limit="67.8"/>
                    <measurement group_id="B3" value="59" lower_limit="52" upper_limit="69"/>
                  </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="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="22"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Need for Endotracheal Intubation</title>
        <description>Number of patients requiring endotracheal intubation after application of helmet device</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
          </group>
          <group group_id="O2">
            <title>Non Invasive Ventilation Via Helmet</title>
            <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
          </group>
        </group_list>
        <measure>
          <title>Need for Endotracheal Intubation</title>
          <description>Number of patients requiring endotracheal intubation after application of helmet device</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Days spent in hospital at time of enrollment</description>
        <time_frame>Duration of hospital stay</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
          </group>
          <group group_id="O2">
            <title>Non Invasive Ventilation Via Helmet</title>
            <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Days spent in hospital at time of enrollment</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="7.8" upper_limit="19.7"/>
                    <measurement group_id="O2" value="10.1" lower_limit="6.5" upper_limit="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Functional Status After Discharge</title>
        <description>Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)</description>
        <time_frame>Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
          </group>
          <group group_id="O2">
            <title>Non Invasive Ventilation Via Helmet</title>
            <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Functional Status After Discharge</title>
          <description>Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilator-free Days</title>
        <description>Duration of mechanical ventilation via endotracheal tube</description>
        <time_frame>number of days in the hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
          </group>
          <group group_id="O2">
            <title>Non Invasive Ventilation Via Helmet</title>
            <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilator-free Days</title>
          <description>Duration of mechanical ventilation via endotracheal tube</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="0.49" upper_limit="28"/>
                    <measurement group_id="O2" value="28" lower_limit="13.7" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Mortality</title>
        <description>Death from any cause during hospitalization at time of enrollment</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
          </group>
          <group group_id="O2">
            <title>Non Invasive Ventilation Via Helmet</title>
            <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Mortality</title>
          <description>Death from any cause during hospitalization at time of enrollment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensive Care Unit Length of Stay</title>
        <description>Number of days admitted to a medical intensive care unit</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
          </group>
          <group group_id="O2">
            <title>Non Invasive Ventilation Via Helmet</title>
            <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensive Care Unit Length of Stay</title>
          <description>Number of days admitted to a medical intensive care unit</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" lower_limit="3.9" upper_limit="13.8"/>
                    <measurement group_id="O2" value="4.7" lower_limit="2.5" upper_limit="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>ICU Complications</title>
        <description>ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness</description>
        <time_frame>6 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Readmission to the Intensive Care Unit</title>
        <description>Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment</description>
        <time_frame>6 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Discharge Location</title>
        <description>Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to</description>
        <time_frame>6 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Improvement of Oxygenation</title>
        <description>Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100</description>
        <time_frame>2 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.&#xD;
Noninvasive ventilation via facemask: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask</description>
        </group>
        <group group_id="E2">
          <title>Non Invasive Ventilation Via Helmet</title>
          <description>Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure&#xD;
Non invasive ventilation using a helmet hyperbaric device: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.&#xD;
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.</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="22" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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>John P. Kress</name_or_title>
      <organization>University of Chicago</organization>
      <phone>7737026790</phone>
      <email>jkress@medicine.bsd.uchicago.edu</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/NCT01680783
org study id: 12-1391
nct id: NCT01680783
lead sponsor: 
has dmc: Yes
The objective of our study is to evaluate the efficacy of helmet ventilation as compared with
      Face mask in patients with respiratory failure.
Respiratory failure is often treated with endotracheal intubation and mechanical ventilation.
      Although, the institution of mechanical ventilation is considered life saving, the associated
      complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and
      neuromuscular weakness are not without considerable morbidity and mortality.

      Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic
      respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory
      failure in immunocompromised patients.

      Despite the advantages of non-invasive ventilation via facemask, some patients fail because
      of mask intolerance and severity of disease. Further limitation to facemask non-invasive
      ventilation is that the seal integrity is lost when higher pressures are required.
      Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock
      may require such higher pressures.

      In an attempt to improve patient tolerability and deliver higher pressures, a transparent
      helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the
      entire head and neck of the patient. The design of the helmet confers some important
      advantages: 1) the transparency allows the patient to interact with the environment; 2) the
      lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems
      of leaking with higher airway pressures that are seen with the face mask; 4) it can be
      applied to any patient regardless of facial contour.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Need for Endotracheal Intubation
time frame: 6 weeks
description: Number of patients requiring endotracheal intubation after application of helmet device
measure: Hospital Length of Stay
time frame: Duration of hospital stay
description: Days spent in hospital at time of enrollment
measure: Number of Participants Functional Status After Discharge
time frame: Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)
description: Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)
measure: Ventilator-free Days
time frame: number of days in the hospital
description: Duration of mechanical ventilation via endotracheal tube
measure: Hospital Mortality
time frame: 90 days
description: Death from any cause during hospitalization at time of enrollment
measure: Intensive Care Unit Length of Stay
time frame: 4 weeks
description: Number of days admitted to a medical intensive care unit
measure: ICU Complications
time frame: 6 weeks
description: ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness
measure: Readmission to the Intensive Care Unit
time frame: 6 weeks
description: Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
measure: Discharge Location
time frame: 6 weeks
description: Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
measure: Improvement of Oxygenation
time frame: 2 weeks
description: Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
arm group label: Usual Care
arm group type: Other
description: Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.
arm group label: Non invasive ventilation via helmet
arm group type: Experimental
description: Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure
intervention type: Device
intervention name: Non invasive ventilation using a helmet hyperbaric device
description: Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
arm group label: Non invasive ventilation via helmet
other name: Sea-Long medical treatment hood
intervention type: Other
intervention name: Noninvasive ventilation via facemask
description: Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
arm group label: Usual Care
other name: mechanical ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: John P Kress, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Pulmonary Edema
mesh term: Hypoventilation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 