<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/NCT02190201</url>
  </required_header>
  <id_info>
    <org_study_id>TJMZK201405001</org_study_id>
    <nct_id>NCT02190201</nct_id>
  </id_info>
  <brief_title>Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation</brief_title>
  <official_title>A Randomised Controlled Trial Comparing McGrath Series 5 Videolaryngoscope and Macintosh Laryngoscope for Double Lumen Tube Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators previous study showed that McGrath Series 5 videolaryngoscope is an&#xD;
      alternative tool for double-lumen tube intubation. But it is not determined about the&#xD;
      advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube&#xD;
      intubation, compared with traditional Macintosh laryngoscope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators designed a randomised controlled study to compare of McGrath Series 5&#xD;
      videolaryngoscope and Macintosh laryngoscope for DLT intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation time</measure>
    <time_frame>at intubation</time_frame>
    <description>measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of successful intubation at first attempt</measure>
    <time_frame>at intubation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Airway evaluation with Cormack-Lehane Score</measure>
    <time_frame>At intubation</time_frame>
    <description>based on Cormack-Lehane classification. degree 1 to 4</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Intubation; Difficult</condition>
  <condition>Thoracic Diseases</condition>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>videolaryngoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DLT intubation with McGrath videolaryngoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct laryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DLT intubation with Macintosh laryngoscope</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>videolaryngoscope</intervention_name>
    <description>a kind of videolaryngoscopes, which are widely used in difficult airways.</description>
    <arm_group_label>videolaryngoscope</arm_group_label>
    <other_name>McGrath series 5 videolaryngoscope</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Direct laryngoscope</intervention_name>
    <description>A kind of traditional laryngoscopes</description>
    <arm_group_label>Direct laryngoscope</arm_group_label>
    <other_name>Macintosh laryngoscopes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  Thoracic surgery required one lung ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult ventilation&#xD;
&#xD;
          -  Emergent operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuke Tian, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tongji Hospital, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Wenlong Yao</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>videolaryngoscope</keyword>
  <keyword>double lumen intubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Diseases</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/NCT02190201
org study id: TJMZK201405001
nct id: NCT02190201
lead sponsor: 
has dmc: Yes
The investigators previous study showed that McGrath Series 5 videolaryngoscope is an
      alternative tool for double-lumen tube intubation. But it is not determined about the
      advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube
      intubation, compared with traditional Macintosh laryngoscope.
The investigators designed a randomised controlled study to compare of McGrath Series 5
      videolaryngoscope and Macintosh laryngoscope for DLT intubation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Intubation time
time frame: at intubation
description: measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade
measure: number of successful intubation at first attempt
time frame: at intubation
measure: Airway evaluation with Cormack-Lehane Score
time frame: At intubation
description: based on Cormack-Lehane classification. degree 1 to 4
arm group label: videolaryngoscope
arm group type: Experimental
description: DLT intubation with McGrath videolaryngoscope
arm group label: Direct laryngoscope
arm group type: Active Comparator
description: DLT intubation with Macintosh laryngoscope
intervention type: Device
intervention name: videolaryngoscope
description: a kind of videolaryngoscopes, which are widely used in difficult airways.
arm group label: videolaryngoscope
other name: McGrath series 5 videolaryngoscope
intervention type: Device
intervention name: Direct laryngoscope
description: A kind of traditional laryngoscopes
arm group label: Direct laryngoscope
other name: Macintosh laryngoscopes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yuke Tian, M.D.
role: Study Chair
affiliation: Huazhong University of Science and Technology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Wenlong Yao
investigator title: M.D.
mesh term: Thoracic Diseases