<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/NCT02224027</url>
  </required_header>
  <id_info>
    <org_study_id>apsj0821</org_study_id>
    <nct_id>NCT02224027</nct_id>
  </id_info>
  <brief_title>Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway</brief_title>
  <official_title>Comparison of Proceal Laryngeal Mask Airway and I-gel to Machintoch Laryngoscope by Novice Operators in Simulated Difficult Airway - a Manikin Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeungnam University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeungnam University College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of laryngeal mask airway or i-gel to manage airway may improve success rates,&#xD;
      especially in difficult situations more than tracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study compares the insertion success rate and insertion time among the proceal laryngeal&#xD;
      mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to&#xD;
      insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult&#xD;
      laryngoscopy scenarios.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt</measure>
    <time_frame>intraoperative</time_frame>
    <description>A blinded observer records the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">109</enrollment>
  <condition>Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>i-gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each novice performs i-gel insertion in difficult laryngoscopy scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>proceal laryngeal mask airway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tracheal tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each novice performs tracheal intubation in difficult laryngoscopy scenario.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>proceal laryngeal mask airway</intervention_name>
    <description>In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.</description>
    <arm_group_label>proceal laryngeal mask airway</arm_group_label>
    <other_name>LMA proceal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tracheal tube</intervention_name>
    <description>In tracheal tube group, tracheal tube is intubated by novices.</description>
    <arm_group_label>tracheal tube</arm_group_label>
    <other_name>TaperGuard</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>i-gel</intervention_name>
    <description>In i-gel group, i-gel is inserted by novices.</description>
    <arm_group_label>i-gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical student&#xD;
&#xD;
          -  nurse&#xD;
&#xD;
          -  no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  experience of insertion using tracheal tube, i-gel, and laryngeal mask airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangjin Park, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sangjin Park, M.D.</last_name>
    <phone>82-53-620-3366</phone>
    <email>apsj0718@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Yeungnam University hospital</name>
      <address>
        <city>Daegu</city>
        <zip>705-035</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duckhee Lee, M.D.</last_name>
      <phone>82-53-620-3365</phone>
      <email>apsj0718@yu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Sangjin Park, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>December 28, 2015</last_update_submitted>
  <last_update_submitted_qc>December 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeungnam University College of Medicine</investigator_affiliation>
    <investigator_full_name>Sangjin Park</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</mesh_term>
  </condition_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/NCT02224027
org study id: apsj0821
nct id: NCT02224027
lead sponsor: 
has dmc: Yes
The use of laryngeal mask airway or i-gel to manage airway may improve success rates,
      especially in difficult situations more than tracheal intubation.
This study compares the insertion success rate and insertion time among the proceal laryngeal
      mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to
      insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult
      laryngoscopy scenarios.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt
time frame: intraoperative
description: A blinded observer records the time of successful laryngeal mask, i-gel, or tracheal tube insertion attempt.
arm group label: i-gel
arm group type: Active Comparator
description: Each novice performs i-gel insertion in difficult laryngoscopy scenario.
arm group label: proceal laryngeal mask airway
arm group type: Active Comparator
description: Each novice performs proceal laryngeal mask airway insertion in difficult laryngoscopy scenario.
arm group label: tracheal tube
arm group type: Active Comparator
description: Each novice performs tracheal intubation in difficult laryngoscopy scenario.
intervention type: Device
intervention name: proceal laryngeal mask airway
description: In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.
arm group label: proceal laryngeal mask airway
other name: LMA proceal
intervention type: Device
intervention name: tracheal tube
description: In tracheal tube group, tracheal tube is intubated by novices.
arm group label: tracheal tube
other name: TaperGuard
intervention type: Device
intervention name: i-gel
description: In i-gel group, i-gel is inserted by novices.
arm group label: i-gel
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sangjin Park, M.D.
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
last name: Sangjin Park, M.D.
phone: 82-53-620-3366
email: apsj0718@naver.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yeungnam University College of Medicine
investigator full name: Sangjin Park
investigator title: assistant professor
mesh term: Airway Obstruction