<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/NCT03818139</url>
  </required_header>
  <id_info>
    <org_study_id>87RI18_0022 (ECHOSI)</org_study_id>
    <nct_id>NCT03818139</nct_id>
  </id_info>
  <brief_title>Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates</brief_title>
  <acronym>ECHOSI</acronym>
  <official_title>Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</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>
      Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube&#xD;
      (ETT) position in adults and children but has been less studied in neonates. The aim of this&#xD;
      study is to evaluate the performance of lung US in determining correct ETT position in&#xD;
      neonates, in comparison with X Ray&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">June 13, 2022</completion_date>
  <primary_completion_date type="Actual">June 13, 2022</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>Concordance of ETT positioning according to lung ultrasonography with chest X ray results</measure>
    <time_frame>Day 0</time_frame>
    <description>X Ray correct ETT position : ETT's tip will be correctly positioned if located between the upper edge of the first thoracic vertebra and the lower edge of the second thoracic vertebra.&#xD;
Ultrasound correct ETT position : ETT'S tip will be correctly positioned if the distance between ETT's tip and the junction of the brachycephalic artery with aortic arch will be measured between 0.8 and 1.5 centimeter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time of realization lung US</measure>
    <time_frame>Day 0</time_frame>
    <description>time of realization lung US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time of realization chest X ray</measure>
    <time_frame>Day 0</time_frame>
    <description>time of realization chest X ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variability inter observator</measure>
    <time_frame>Day 0</time_frame>
    <description>Concordance of thoracic ultrasound results between the operator and the reviewer</description>
  </secondary_outcome>
  <enrollment type="Actual">55</enrollment>
  <condition>Diagnostic Imaging</condition>
  <condition>Newborn</condition>
  <condition>Intubation</condition>
  <condition>Ultrasonography</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>radiography thorax</intervention_name>
    <description>The ultrasound of the thorax will be performed while waiting for the X-ray thorax</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newborns treated with mechanical ventilation and required chest X ray for determining ETT&#xD;
        position&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborns&#xD;
&#xD;
          -  treated with mechanical ventilation&#xD;
&#xD;
          -  and required chest X ray for determining ETT position&#xD;
&#xD;
          -  hospitalised in neonatal intensive Care unit , Limoges, France&#xD;
&#xD;
          -  signed parental inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital, Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diagnostic imaging, Newborn, Intubation, Ultrasonography methods</keyword>
  <!-- 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/NCT03818139
org study id: 87RI18_0022 (ECHOSI)
nct id: NCT03818139
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube
      (ETT) position in adults and children but has been less studied in neonates. The aim of this
      study is to evaluate the performance of lung US in determining correct ETT position in
      neonates, in comparison with X Ray
observational model: Cohort
time perspective: Prospective
measure: Concordance of ETT positioning according to lung ultrasonography with chest X ray results
time frame: Day 0
description: X Ray correct ETT position : ETT's tip will be correctly positioned if located between the upper edge of the first thoracic vertebra and the lower edge of the second thoracic vertebra.
Ultrasound correct ETT position : ETT'S tip will be correctly positioned if the distance between ETT's tip and the junction of the brachycephalic artery with aortic arch will be measured between 0.8 and 1.5 centimeter
measure: time of realization lung US
time frame: Day 0
description: time of realization lung US
measure: time of realization chest X ray
time frame: Day 0
description: time of realization chest X ray
measure: variability inter observator
time frame: Day 0
description: Concordance of thoracic ultrasound results between the operator and the reviewer
intervention type: Other
intervention name: radiography thorax
description: The ultrasound of the thorax will be performed while waiting for the X-ray thorax
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor