<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/NCT04457453</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-OBS-19-507</org_study_id>
    <nct_id>NCT04457453</nct_id>
  </id_info>
  <brief_title>Comparison of Direct and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position</brief_title>
  <official_title>Comparison of Direct Laryngoscope and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position to Prevent Pulmonary Aspiration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory&#xD;
      complications. Takenaka's study of mannequins reported that the risk of airway contamination&#xD;
      by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position&#xD;
      and a Sellick position with neck extention. However, the clinical performance of tracheal&#xD;
      intubation in this position has not been studied. Also, the difference between the effects of&#xD;
      direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.&#xD;
&#xD;
      Therefore, this study aims to compare the intubation time among intubation through direct&#xD;
      laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation&#xD;
      in the conventional sniffing position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2021</start_date>
  <completion_date type="Actual">April 7, 2022</completion_date>
  <primary_completion_date type="Actual">April 7, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation time</measure>
    <time_frame>within 5 minutes</time_frame>
    <description>from endotracheal tube pass the teeth to end-tidal CO2 appear</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intubation difficulty score</measure>
    <time_frame>within 5 minutes</time_frame>
    <description>Intubation difficulty scale (IDS) score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Intubation;Difficult</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intubation with direct laryngoscope in sniffing position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>direct laryngoscope in Trendelenburg and Sellick position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation with direct laryngoscope in Trendelenburg and Sellick position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>video laryngoscope in Trendelenburg and Sellick position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation with video laryngoscope in Trendelenburg and Sellick position</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Macintosh in sniffing position</intervention_name>
    <description>Macintosh direct intubation in sniffing position</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Macintosh in Trendelenburg position and Sellick position</intervention_name>
    <description>Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position</description>
    <arm_group_label>direct laryngoscope in Trendelenburg and Sellick position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AceScope in Trendelenburg position and Sellick position</intervention_name>
    <description>AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position</description>
    <arm_group_label>video laryngoscope in Trendelenburg and Sellick position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 19 years old&#xD;
&#xD;
          -  ASA I or II&#xD;
&#xD;
          -  Patients who need nasotracheal intubation for surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anatomical deformity in head and neck&#xD;
&#xD;
          -  Patients who have risk of pulmonary aspiration&#xD;
&#xD;
          -  Patients with cervical deformities or pain&#xD;
&#xD;
          -  BMI &gt;35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yun jeong chae, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou universitiy school of medicine</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeong-gi Do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>yun jeong chae</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Trendelenburg position</keyword>
  <keyword>Sellick position</keyword>
  <keyword>pulmonary aspiration</keyword>
  <keyword>video laryngoscope</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/NCT04457453
org study id: AJIRB-MED-OBS-19-507
nct id: NCT04457453
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory
      complications. Takenaka's study of mannequins reported that the risk of airway contamination
      by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position
      and a Sellick position with neck extention. However, the clinical performance of tracheal
      intubation in this position has not been studied. Also, the difference between the effects of
      direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.

      Therefore, this study aims to compare the intubation time among intubation through direct
      laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation
      in the conventional sniffing position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Intubation time
time frame: within 5 minutes
description: from endotracheal tube pass the teeth to end-tidal CO2 appear
measure: Intubation difficulty score
time frame: within 5 minutes
description: Intubation difficulty scale (IDS) score
arm group label: control group
arm group type: Active Comparator
description: intubation with direct laryngoscope in sniffing position
arm group label: direct laryngoscope in Trendelenburg and Sellick position
arm group type: Experimental
description: intubation with direct laryngoscope in Trendelenburg and Sellick position
arm group label: video laryngoscope in Trendelenburg and Sellick position
arm group type: Experimental
description: intubation with video laryngoscope in Trendelenburg and Sellick position
intervention type: Other
intervention name: Macintosh in sniffing position
description: Macintosh direct intubation in sniffing position
arm group label: control group
intervention type: Other
intervention name: Macintosh in Trendelenburg position and Sellick position
description: Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position
arm group label: direct laryngoscope in Trendelenburg and Sellick position
intervention type: Other
intervention name: AceScope in Trendelenburg position and Sellick position
description: AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position
arm group label: video laryngoscope in Trendelenburg and Sellick position
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: yun jeong chae, Ph.D
role: Principal Investigator
affiliation: Ajou University School of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: yun jeong chae
investigator title: Professor