<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/NCT03031548</url>
  </required_header>
  <id_info>
    <org_study_id>5160372</org_study_id>
    <nct_id>NCT03031548</nct_id>
  </id_info>
  <brief_title>Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population</brief_title>
  <acronym>POCUS</acronym>
  <official_title>Intraoperative Point-of Care Ultrasound for Identification of Endotracheal Tube Position in the Pediatric Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda 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>
      Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube&#xD;
      (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all&#xD;
      intubations result in inappropriate ETT placement. An adult study has shown that ultrasound&#xD;
      point-of-care is superior to auscultation in determining the location of ETT. This study aims&#xD;
      to determine if point-of-care is useful in determining ETT position in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is&#xD;
      routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal&#xD;
      tube position. An anesthesiologist will perform the ultrasound exam.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Endotracheal Tube Position</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>The primary outcome marker for this study was the correlation between the weighted POCUS measurement of TT location and the weighted fluoroscopy measurement of TT location</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Endotracheal Tube Wrongly Placed During Anesthetic Procedure</condition>
  <arm_group>
    <arm_group_label>ultrasound exam</arm_group_label>
    <description>Child undergoing procedure in CVL requiring ETT and CXR as standard of care - received point-of-care ultrasound exam as part of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point-of-care ultrasound exam</intervention_name>
    <description>No intervention</description>
    <arm_group_label>ultrasound exam</arm_group_label>
    <other_name>POC ultrasound</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Reposition ETT</intervention_name>
    <description>ETT will be repositioned based on CXR by fluoroscopy</description>
    <arm_group_label>ultrasound exam</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children who require general anesthesia and endotracheal intubation for procedures in the&#xD;
        cardiovascular laboratory&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. children birth to 10 years of age;&#xD;
&#xD;
          2. undergoing cardiac catheterization in the cath lab;&#xD;
&#xD;
          3. general anesthesia with an endotracheal tube;&#xD;
&#xD;
          4. subjects will also receive a chest x-ray as standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. children ages birth to 10 years undergoing cardiac catheterization under GA without an&#xD;
             endotracheal tube;&#xD;
&#xD;
          2. emergency procedures;&#xD;
&#xD;
          3. known airway anomalies;&#xD;
&#xD;
          4. children who are non-English and non-Spanish speaking -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Ghazal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda University Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Department of Anesthesiology</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loma Linda University</investigator_affiliation>
    <investigator_full_name>Elizabeth Ghazal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03031548
org study id: 5160372
nct id: NCT03031548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube
      (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all
      intubations result in inappropriate ETT placement. An adult study has shown that ultrasound
      point-of-care is superior to auscultation in determining the location of ETT. This study aims
      to determine if point-of-care is useful in determining ETT position in children.
Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is
      routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal
      tube position. An anesthesiologist will perform the ultrasound exam.
observational model: Cohort
time perspective: Prospective
measure: Endotracheal Tube Position
time frame: through study completion, an average of 1 year
description: The primary outcome marker for this study was the correlation between the weighted POCUS measurement of TT location and the weighted fluoroscopy measurement of TT location
arm group label: ultrasound exam
description: Child undergoing procedure in CVL requiring ETT and CXR as standard of care - received point-of-care ultrasound exam as part of the study
intervention type: Device
intervention name: Point-of-care ultrasound exam
description: No intervention
arm group label: ultrasound exam
other name: POC ultrasound
intervention type: Radiation
intervention name: Reposition ETT
description: ETT will be repositioned based on CXR by fluoroscopy
arm group label: ultrasound exam
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 10 Years
healthy volunteers: No
last name: Elizabeth Ghazal, MD
role: Principal Investigator
affiliation: Loma Linda University Health
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loma Linda University
investigator full name: Elizabeth Ghazal
investigator title: Principal Investigator
sharing ipd: No