<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/NCT04473300</url>
  </required_header>
  <id_info>
    <org_study_id>ASPEIT</org_study_id>
    <nct_id>NCT04473300</nct_id>
  </id_info>
  <brief_title>Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography</brief_title>
  <official_title>Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osaka University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Rebagliati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Osaka University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often&#xD;
      develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy&#xD;
      consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is&#xD;
      recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have&#xD;
      the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the&#xD;
      investigators propose an observational study to analyze respiratory mechanics and lung&#xD;
      recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to&#xD;
      SARS-CoV-2 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The multi-center prospective observational study will enroll 20 adult ARDS patients under&#xD;
      mechanical ventilation from Intensive Care Units (ICUs) in Japan and Peru. Informed consent&#xD;
      will be waived due to the nature of observational study. Patients with positive SARS-CoV-2&#xD;
      infection will be included. Prior to initiating the protocol, patients will be sedated deeply&#xD;
      with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. The&#xD;
      distribution of ventilation will be evaluated with EIT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The distribution of ventilation</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>The distribution of ventilation measured by EIT at PEEP 5 and 15.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Silent spaces</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory system compliance</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Respiratory system compliance in PEEP 5 and 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Oxygenation in PEEP 5 and 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dead space ventilation ratio</measure>
    <time_frame>Through study completion (up to 24 hours)</time_frame>
    <description>Dead space ventilation ratio in PEEP 5 and 15.</description>
  </secondary_outcome>
  <enrollment type="Actual">43</enrollment>
  <condition>Critical Illness</condition>
  <condition>ARDS</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with ARDS due to SARS-CoV-2 pneumonia under mechanical ventilation in&#xD;
        intensive care unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with positive SARS-CoV-2 infection＊&#xD;
&#xD;
          2. Patients with ARDS under mechanical ventilation＊＊&#xD;
&#xD;
          3. Patients ≧ 18 years old&#xD;
&#xD;
               -  Definition of SARS-CoV-2 infection positive: SARS-CoV-2 infection is defined as&#xD;
                  being positive in RT-PCR (real time reverse transcriptase-polymerase chain&#xD;
                  reaction) assay using nasal or pharyngeal swab samples.&#xD;
&#xD;
                    -  Definition of ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 300 mmHg&#xD;
                       with PEEP ≧ 5 cmH2O)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication for EIT monitoring&#xD;
&#xD;
               1. Unstable spine or pelvic fractures&#xD;
&#xD;
               2. Pacemaker, automatic implantable cardioverter defibrillator&#xD;
&#xD;
               3. Skin lesions between the 4th and 5th ribs where the EIT belt is worn&#xD;
&#xD;
          2. Home mechanical ventilation before inclusion&#xD;
&#xD;
          3. Pregnancy&#xD;
&#xD;
          4. DNR (do-not-resuscitate)&#xD;
&#xD;
          5. Increased intracranial pressure (&gt; 18 mmHg)&#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>Takeshi Yoshida, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Osaka University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>electrical impedance tomography</keyword>
  <keyword>positive end expiratory pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04473300
org study id: ASPEIT
nct id: NCT04473300
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often
      develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy
      consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is
      recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have
      the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the
      investigators propose an observational study to analyze respiratory mechanics and lung
      recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to
      SARS-CoV-2 pneumonia.
The multi-center prospective observational study will enroll 20 adult ARDS patients under
      mechanical ventilation from Intensive Care Units (ICUs) in Japan and Peru. Informed consent
      will be waived due to the nature of observational study. Patients with positive SARS-CoV-2
      infection will be included. Prior to initiating the protocol, patients will be sedated deeply
      with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. The
      distribution of ventilation will be evaluated with EIT.
observational model: Cohort
time perspective: Prospective
measure: The distribution of ventilation
time frame: Through study completion (up to 24 hours)
description: The distribution of ventilation measured by EIT at PEEP 5 and 15.
measure: Silent spaces
time frame: Through study completion (up to 24 hours)
description: The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.
measure: Respiratory system compliance
time frame: Through study completion (up to 24 hours)
description: Respiratory system compliance in PEEP 5 and 15.
measure: Oxygenation
time frame: Through study completion (up to 24 hours)
description: Oxygenation in PEEP 5 and 15.
measure: Dead space ventilation ratio
time frame: Through study completion (up to 24 hours)
description: Dead space ventilation ratio in PEEP 5 and 15.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Takeshi Yoshida, M.D., Ph.D.
role: Principal Investigator
affiliation: Osaka University
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Critical Illness
sharing ipd: No