<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/NCT04438772</url>
  </required_header>
  <id_info>
    <org_study_id>LPEConditions</org_study_id>
    <nct_id>NCT04438772</nct_id>
  </id_info>
  <brief_title>Effect of LPEC Compared With a Sham Procedure in the General Anesthesia</brief_title>
  <official_title>Effect of LPEC Compared With a Sham Procedure in the General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      Check the condition of intubation with LPEC compared with a sham procedure in the general&#xD;
      anesthesia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cormack score</measure>
    <time_frame>During laryngoscopy</time_frame>
    <description>from 0 to 4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to intubation</measure>
    <time_frame>During laryngoscopy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intubation;Difficult</condition>
  <arm_group>
    <arm_group_label>LPEC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham procedure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia</intervention_name>
    <description>Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition</description>
    <arm_group_label>LPEC</arm_group_label>
    <arm_group_label>Sham procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ENT neoplasia&#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>Benjamin Javillier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Liege</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin Javillier, MD</last_name>
    <phone>003243667180</phone>
    <email>benjamin.javillier@chuliege.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Javillier</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Javillier, MD</last_name>
      <phone>003243667180</phone>
      <email>benjamin.javillier@chuliege.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Benjamin Javillier</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04438772
org study id: LPEConditions
nct id: NCT04438772
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Check the condition of intubation with LPEC compared with a sham procedure in the general
      anesthesia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Cormack score
time frame: During laryngoscopy
description: from 0 to 4
measure: Time to intubation
time frame: During laryngoscopy
arm group label: LPEC
arm group type: Experimental
arm group label: Sham procedure
arm group type: Sham Comparator
intervention type: Other
intervention name: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia
description: Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition
arm group label: LPEC
arm group label: Sham procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Javillier, MD
role: Principal Investigator
affiliation: University of Liege
last name: Benjamin Javillier, MD
phone: 003243667180
email: benjamin.javillier@chuliege.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Benjamin Javillier
investigator title: Principal Investigator
mesh term: Anesthetics