<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/NCT03793842</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00148126</org_study_id>
    <nct_id>NCT03793842</nct_id>
  </id_info>
  <brief_title>Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome</brief_title>
  <official_title>Use of Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Doctors follow a standard ventilator management strategy when making adjustments to the&#xD;
      breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study&#xD;
      is to assess whether the EIT (electrical impedance tomography) device can be an additional&#xD;
      useful tool for ventilator management and identifying the ideal positive end-expiratory&#xD;
      pressure (PEEP).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">June 24, 2022</completion_date>
  <primary_completion_date type="Actual">June 24, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in lung inflammation as measured by physiologic parameter: Mechanical Power</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Physiological parameter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2)</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Physiologic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen/Fraction of Inspired Oxygen (P/F ratio)</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Physiologic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lung inflammation as measured by physiologic parameter: Plateau pressure</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Physiologic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung inflammation as measured by physiologic parameter: Driving Pressure</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Physiologic parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lung inflammation as measured by physiologic parameter: Static compliance</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Physiologic parameter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Usual care then PEEP titration by EIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan ARDS protocol high-PEEP arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEEP titration by EIT then usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.</description>
    <arm_group_label>PEEP titration by EIT then usual care</arm_group_label>
    <arm_group_label>Usual care then PEEP titration by EIT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEP titration by EIT</intervention_name>
    <description>PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).</description>
    <arm_group_label>PEEP titration by EIT then usual care</arm_group_label>
    <arm_group_label>Usual care then PEEP titration by EIT</arm_group_label>
    <other_name>Drager PulmoVista 500 EIT System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Endotracheal ventilation for &lt; 1 week (168 hours)&#xD;
&#xD;
          -  Presence of all of the following conditions for &lt; 48 hours i. PaO2/FiO2 &lt; 150 with&#xD;
             PEEP &gt; 5 cm H2O for &gt; 30 min. ii. bilateral opacities not fully explained by&#xD;
             effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully&#xD;
             explained by cardiac failure or fluid overload&#xD;
&#xD;
          -  All criteria listed in (3) developed within 1 week of a known clinical insult or new&#xD;
             or worsening respiratory symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  ECMO&#xD;
&#xD;
          -  Severe chronic respiratory disease requiring home oxygen therapy or ventilation&#xD;
&#xD;
          -  Calculated BMI of greater than 50&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Hyzy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>June 24, 2022</last_update_submitted>
  <last_update_submitted_qc>June 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Robert C. Hyzy, MD</investigator_full_name>
    <investigator_title>Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Electrical Impedance Tomography</keyword>
  <keyword>Ventilator</keyword>
  <keyword>Lung</keyword>
  <keyword>Respiration</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>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 26, 2023</submitted>
    <returned>August 22, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793842
org study id: HUM00148126
nct id: NCT03793842
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Doctors follow a standard ventilator management strategy when making adjustments to the
      breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study
      is to assess whether the EIT (electrical impedance tomography) device can be an additional
      useful tool for ventilator management and identifying the ideal positive end-expiratory
      pressure (PEEP).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in lung inflammation as measured by physiologic parameter: Mechanical Power
time frame: Up to 24 hours
description: Physiological parameter
measure: Change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2)
time frame: Up to 24 hours
description: Physiologic parameter
measure: Change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen/Fraction of Inspired Oxygen (P/F ratio)
time frame: Up to 24 hours
description: Physiologic parameter
measure: Change in lung inflammation as measured by physiologic parameter: Plateau pressure
time frame: Up to 24 hours
description: Physiologic parameter
measure: Lung inflammation as measured by physiologic parameter: Driving Pressure
time frame: Up to 24 hours
description: Physiologic parameter
measure: Change in lung inflammation as measured by physiologic parameter: Static compliance
time frame: Up to 24 hours
description: Physiologic parameter
arm group label: Usual care then PEEP titration by EIT
arm group type: Experimental
description: Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan ARDS protocol high-PEEP arm
arm group label: PEEP titration by EIT then usual care
arm group type: Experimental
description: Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.
intervention type: Other
intervention name: Usual care
description: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
arm group label: PEEP titration by EIT then usual care
arm group label: Usual care then PEEP titration by EIT
intervention type: Device
intervention name: PEEP titration by EIT
description: PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
arm group label: PEEP titration by EIT then usual care
arm group label: Usual care then PEEP titration by EIT
other name: Drager PulmoVista 500 EIT System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Hyzy, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Robert C. Hyzy, MD
investigator title: Professor of Internal Medicine
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: No
submitted: July 26, 2023
returned: August 22, 2023