<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/NCT01669863</url>
  </required_header>
  <id_info>
    <org_study_id>MHH-6208</org_study_id>
    <nct_id>NCT01669863</nct_id>
  </id_info>
  <brief_title>Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)</brief_title>
  <official_title>Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hannover Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute&#xD;
      respiratory failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid&#xD;
      endotracheal intubation and mechanical ventilation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Did Not Require Endotrachael Intubation</measure>
    <time_frame>Duration of ICU stay</time_frame>
    <description>- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Presented With ECMO-Related Complications</measure>
    <time_frame>Duration of ICU stay</time_frame>
    <description>ECMO-related complications</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Oxygenation Index During Application of ECMO</measure>
    <time_frame>Duration of ICU stay</time_frame>
    <description>Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Use of ECMO in non-intubated patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ECMO will be used in non-intubated patients with ARDS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECMO</intervention_name>
    <description>Use of veno-venous ECMO in non-intubated patients with ARDS</description>
    <arm_group_label>Use of ECMO in non-intubated patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ECMO in non-intubated patients</intervention_name>
    <description>Use of veno-venous ECMO in non-intubated patients with ARDS</description>
    <arm_group_label>Use of ECMO in non-intubated patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-75 yrs with acute respiratory failure due to ARDS or pneumonia&#xD;
             fulfilling standard criteria for endotracheal intubation&#xD;
&#xD;
               -  Severe and progressive hypoxemia, i.e. PaO2 &lt; 60 mmHg or SaO2 &lt; 90% on O2 &gt; 10&#xD;
                  l/min not tolerating noninvasive ventilation, or&#xD;
&#xD;
               -  PaO2/FiO2 &lt; 200 not improving or deteriorating on noninvasive ventilation, or&#xD;
&#xD;
               -  Respiratory distress and hypoxemia not fulfilling the criteria above with&#xD;
                  clinical impression of the ICU attending that intubation and mechanical&#xD;
                  ventilation are mandated&#xD;
&#xD;
          -  Patient considered eligible by at least two investigators of this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient does not fulfill the inclusion criteria&#xD;
&#xD;
          -  Uncontrolled malignancy&#xD;
&#xD;
          -  Severe and untreatable coagulation or bleeding disorders (INR &gt; 2,0; aPTT &gt; 60s,&#xD;
             Platelet count &lt; 50.000/µl, all after substitution)&#xD;
&#xD;
          -  Stroke within the past 3 months&#xD;
&#xD;
          -  Uncontrolled sepsis or septic shock&#xD;
&#xD;
          -  Multiorgan failure involving &gt; 2 organ systems&#xD;
&#xD;
          -  Norepinephrine dose &gt; 1 mg/h&#xD;
&#xD;
          -  Hyperdynamic circulation, indicated by cardiac index &gt; 4.0 l/min/m2 (measured by PiCCO&#xD;
             or Swan-Ganz catheter), or SvO2 &gt; 80%&#xD;
&#xD;
          -  Cardiac pump failure, indicated by echocardiography (EF &lt; 40%), PiCCO or Swan Ganz&#xD;
             catheter (CI &lt; 2,5 l/min/m2 despite adequate volume management), or SvO2 &lt; 50%&#xD;
             (provided Hb &gt; 9,0 g/dl and SaO2 &gt; 90%), or the need for inotropes (dobutamine,&#xD;
             epinephrine, levosimendan)&#xD;
&#xD;
          -  Clinical or echocardiographic signs of pulmonary hypertension with right ventricular&#xD;
             dysfunction&#xD;
&#xD;
          -  APACHE-II score15 &lt; 25&#xD;
&#xD;
          -  Other conditions suggesting that the patient would benefit from intubation and&#xD;
             mechanical ventilation&#xD;
&#xD;
          -  Severe neurological disorders&#xD;
&#xD;
          -  Estimated mortality due to severity of acute and/or underlying illness &gt; 50%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marius M Hoeper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hannover Medical School</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>March 17, 2015</results_first_submitted>
  <results_first_submitted_qc>April 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 23, 2015</results_first_posted>
  <last_update_submitted>April 22, 2015</last_update_submitted>
  <last_update_submitted_qc>April 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hannover Medical School</investigator_affiliation>
    <investigator_full_name>Marius Hoeper, MD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>ARDS</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>6 patients recruited as planned</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Use of ECMO in Non-intubated Patients</title>
          <description>ECMO used in non-intubated patients with ARDS&#xD;
ECMO&#xD;
ECMO in non-intubated patients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Use of ECMO in Non-intubated Patients</title>
          <description>ECMO group</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" spread="10"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Did Not Require Endotrachael Intubation</title>
        <description>- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.</description>
        <time_frame>Duration of ICU stay</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Use of ECMO in Non-intubated Patients</title>
            <description>ECMO will be used in non-intubated patients with ARDS&#xD;
ECMO&#xD;
ECMO in non-intubated patients</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Did Not Require Endotrachael Intubation</title>
          <description>- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Presented With ECMO-Related Complications</title>
        <description>ECMO-related complications</description>
        <time_frame>Duration of ICU stay</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Use of ECMO in Non-intubated Patients</title>
            <description>ECMO in non-intubated patients</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Presented With ECMO-Related Complications</title>
          <description>ECMO-related complications</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </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>
        <type>Other Pre-specified</type>
        <title>Change in Oxygenation Index During Application of ECMO</title>
        <description>Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay</description>
        <time_frame>Duration of ICU stay</time_frame>
        <population>Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.</population>
        <group_list>
          <group group_id="O1">
            <title>Use of ECMO in Non-intubated Patients</title>
            <description>ECMO in non-intubated patients</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Oxygenation Index During Application of ECMO</title>
          <description>Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay</description>
          <population>Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Use of ECMO in Non-intubated Patients</title>
          <description>Patients on ECMO</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Accidental ECMO line removal</sub_title>
                <description>Patient intentionally removed his ECMO line</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
              </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="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Marius Hoeper</name_or_title>
      <organization>Hannover Medical School</organization>
      <phone>00495115323530</phone>
      <email>hoeper.marius@mh-hannover.de</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/NCT01669863
org study id: MHH-6208
nct id: NCT01669863
lead sponsor: 
has dmc: No
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute
      respiratory failure
Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid
      endotracheal intubation and mechanical ventilation
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants That Did Not Require Endotrachael Intubation
time frame: Duration of ICU stay
description: - N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.
measure: Number of Participants Who Presented With ECMO-Related Complications
time frame: Duration of ICU stay
description: ECMO-related complications
measure: Change in Oxygenation Index During Application of ECMO
time frame: Duration of ICU stay
description: Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay
arm group label: Use of ECMO in non-intubated patients
arm group type: Experimental
description: ECMO will be used in non-intubated patients with ARDS
intervention type: Device
intervention name: ECMO
description: Use of veno-venous ECMO in non-intubated patients with ARDS
arm group label: Use of ECMO in non-intubated patients
intervention type: Procedure
intervention name: ECMO in non-intubated patients
description: Use of veno-venous ECMO in non-intubated patients with ARDS
arm group label: Use of ECMO in non-intubated patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marius M Hoeper, MD
role: Principal Investigator
affiliation: Hannover Medical School
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Hannover Medical School
investigator full name: Marius Hoeper, MD
investigator title: Principle Investigator
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 