<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/NCT04419064</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20050011</org_study_id>
    <nct_id>NCT04419064</nct_id>
  </id_info>
  <brief_title>Confirmation of Ventilation and Intubation by Determination With Ultrasonography</brief_title>
  <acronym>COVID-US</acronym>
  <official_title>Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kadlec Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound&#xD;
      can be a useful alternative. The investigators are conducting a multi-center, observational&#xD;
      study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal&#xD;
      and lung ultrasound in confirming endotracheal tube placement in the critically ill.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endotracheal intubation is an important aspect of managing critically ill patients. Chest&#xD;
      radiography remains the gold standard for confirming endotracheal tube positioning, however,&#xD;
      ultrasonography can be a useful alternative. The objective of this study is to determine the&#xD;
      feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate&#xD;
      positioning of endotracheal tube placement in a cohort of critically ill participants&#xD;
      including those with novel coronavirus-2019.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concordance with next occurring chest radiograph</measure>
    <time_frame>within 24 hours</time_frame>
    <description>Adequate endotracheal tube position in agreement with chest radiograph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Esophageal Intubation detection</measure>
    <time_frame>within intubation attempt</time_frame>
    <description>Number of esophageal intubations detected during intubation attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right main or endobronchial intubation</measure>
    <time_frame>within intubation attempt</time_frame>
    <description>Number of right main stem intubations detected with ultrasonography</description>
  </secondary_outcome>
  <enrollment type="Actual">118</enrollment>
  <condition>Critical Illness</condition>
  <condition>Mechanical Ventilation</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point of care ultrasound</intervention_name>
    <description>Tracheal and lung ultrasonography</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients, &gt; 18 years of age, undergoing intubation and mechanical ventilation from 4&#xD;
        multiple intensive care units from 4 different academic and community hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt; or equal to 18 years of age) requiring intubation and mechanical&#xD;
             ventilation as a part of their routine care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent neck or chest surgery&#xD;
&#xD;
          -  Cervical spine immobilization&#xD;
&#xD;
          -  Lack of availability of operators or equipment for performing the ultrasound protocol&#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>Mourad H Senussi, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kadlec Regional Medical Center</name>
      <address>
        <city>Richland</city>
        <state>Washington</state>
        <zip>99352</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Mourad Senussi</investigator_full_name>
    <investigator_title>Clinical Instructor of Medicine</investigator_title>
  </responsible_party>
  <keyword>intubation</keyword>
  <keyword>bedside ultrasound</keyword>
  <keyword>point-of-care ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04419064
org study id: STUDY20050011
nct id: NCT04419064
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound
      can be a useful alternative. The investigators are conducting a multi-center, observational
      study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal
      and lung ultrasound in confirming endotracheal tube placement in the critically ill.
Endotracheal intubation is an important aspect of managing critically ill patients. Chest
      radiography remains the gold standard for confirming endotracheal tube positioning, however,
      ultrasonography can be a useful alternative. The objective of this study is to determine the
      feasibility of a combination of tracheal and thoracic ultrasonography to confirm adequate
      positioning of endotracheal tube placement in a cohort of critically ill participants
      including those with novel coronavirus-2019.
observational model: Cohort
time perspective: Retrospective
measure: Concordance with next occurring chest radiograph
time frame: within 24 hours
description: Adequate endotracheal tube position in agreement with chest radiograph
measure: Esophageal Intubation detection
time frame: within intubation attempt
description: Number of esophageal intubations detected during intubation attempt
measure: Right main or endobronchial intubation
time frame: within intubation attempt
description: Number of right main stem intubations detected with ultrasonography
intervention type: Diagnostic Test
intervention name: Point of care ultrasound
description: Tracheal and lung ultrasonography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mourad H Senussi, MD, MS
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Mourad Senussi
investigator title: Clinical Instructor of Medicine
mesh term: Critical Illness
sharing ipd: No