<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/NCT02997488</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-DEV-OBS-16-473</org_study_id>
    <nct_id>NCT02997488</nct_id>
  </id_info>
  <brief_title>Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope</brief_title>
  <official_title>Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope</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>
  <brief_summary>
    <textblock>
      Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes&#xD;
      provide easier intubation, help intubation difficulty, are used good tool for education.&#xD;
      McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.&#xD;
&#xD;
      The purpose of this study is to compare of routine endotracheal intubation with McGrath&#xD;
      Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier&#xD;
      and faster intubation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">June 14, 2017</completion_date>
  <primary_completion_date type="Actual">June 14, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to intubation</measure>
    <time_frame>10 minutes around intubation</time_frame>
    <description>from entering of blade between incisors to appearance of first end tidal CO2 curve using capnograph</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Intubation</condition>
  <arm_group>
    <arm_group_label>McGrath</arm_group_label>
    <description>McGrath Videolaryngoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pentax</arm_group_label>
    <description>Pentax Airwayscope</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pentax Airwayscope</intervention_name>
    <description>intubation using Pentax Airwayscope</description>
    <arm_group_label>Pentax</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>McGrath Videolaryngoscope</intervention_name>
    <description>intubation using McGrath Videolaryngoscope</description>
    <arm_group_label>McGrath</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients scheduled for elective surgery requiring orotracheal intubation in our hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an American Society of Anesthesiologists physical status (ASA) 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a suspected difficult airway (Mallampati score Ⅳ)&#xD;
&#xD;
          -  known cervical spine injury&#xD;
&#xD;
          -  required rapid sequence induction&#xD;
&#xD;
          -  emergency operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiyoung Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou University School of Medicine</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>June 14, 2017</last_update_submitted>
  <last_update_submitted_qc>June 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</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>Jiyoung Lee</investigator_full_name>
    <investigator_title>Clinical assistant prefessor</investigator_title>
  </responsible_party>
  <keyword>videolaryngoscope</keyword>
  <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/NCT02997488
org study id: AJIRB-DEV-OBS-16-473
nct id: NCT02997488
lead sponsor: 
Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes
      provide easier intubation, help intubation difficulty, are used good tool for education.
      McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.

      The purpose of this study is to compare of routine endotracheal intubation with McGrath
      Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier
      and faster intubation.
observational model: Case-Control
time perspective: Prospective
measure: Time to intubation
time frame: 10 minutes around intubation
description: from entering of blade between incisors to appearance of first end tidal CO2 curve using capnograph
arm group label: McGrath
description: McGrath Videolaryngoscope
arm group label: Pentax
description: Pentax Airwayscope
intervention type: Device
intervention name: Pentax Airwayscope
description: intubation using Pentax Airwayscope
arm group label: Pentax
intervention type: Device
intervention name: McGrath Videolaryngoscope
description: intubation using McGrath Videolaryngoscope
arm group label: McGrath
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jiyoung Lee, MD
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, 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: Jiyoung Lee
investigator title: Clinical assistant prefessor
sharing ipd: No