<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/NCT03000088</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-DE4-15-414</org_study_id>
    <nct_id>NCT03000088</nct_id>
  </id_info>
  <brief_title>Stylet Angle for McGrath Videolaryngoscopy</brief_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>
      The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an&#xD;
      endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this&#xD;
      study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Intubation</condition>
  <arm_group>
    <arm_group_label>60° angle group</arm_group_label>
    <description>intubate using McGrath Videolaryngoscope with 60° angled stylet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90°angle group</arm_group_label>
    <description>intubate using McGrath Videolaryngoscope with 90° angled stylet</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intubate with 60° angled stylet</intervention_name>
    <arm_group_label>60° angle group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intubate with 60° angled stylet</intervention_name>
    <arm_group_label>90°angle group</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>70 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>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>January 13, 2017</results_first_submitted>
  <results_first_submitted_qc>March 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2017</results_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study enrolled patients scheduled for elective surgery requiring orotracheal intubation in our hospital. The last patient completed in August 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>60° Angle Group</title>
          <description>intubate using McGrath Videolaryngoscope with 60° angled stylet&#xD;
intubate with 60° angled stylet</description>
        </group>
        <group group_id="P2">
          <title>90°Angle Group</title>
          <description>intubate using McGrath Videolaryngoscope with 90° angled stylet&#xD;
intubate with 60° angled stylet</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>60° Angle Group</title>
          <description>intubate using McGrath Videolaryngoscope with 60° angled stylet&#xD;
intubate with 60° angled stylet</description>
        </group>
        <group group_id="B2">
          <title>90°Angle Group</title>
          <description>intubate using McGrath Videolaryngoscope with 90° angled stylet&#xD;
intubate with 60° angled stylet</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" spread="14"/>
                    <measurement group_id="B2" value="41" spread="14"/>
                    <measurement group_id="B3" value="41" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Thyromental distance</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.2" spread="1.3"/>
                    <measurement group_id="B2" value="9.2" spread="1.4"/>
                    <measurement group_id="B3" value="9.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mouth opening</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.4" spread="1.1"/>
                    <measurement group_id="B2" value="5.2" spread="0.9"/>
                    <measurement group_id="B3" value="5.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>range of motion of cervical spine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>normal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>reduced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>fixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>upper incisors status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>normal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>absent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>fixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mallampati score</title>
          <description>Lower Mallamlapti score predicts easier intubation than did higher Mallampati score.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mallampati score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mallampati score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mallampati score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Intubation</title>
        <time_frame>10 minutes around intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>90°Angle Group</title>
            <description>intubate using McGrath Videolaryngoscope with 90° angled stylet&#xD;
intubate with 60° angled stylet</description>
          </group>
          <group group_id="O2">
            <title>60° Angle Group</title>
            <description>intubate using McGrath Videolaryngoscope with 60° angled stylet&#xD;
intubate with 60° angled stylet</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Intubation</title>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="9.4"/>
                    <measurement group_id="O2" value="29.3" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>60° Angle Group</title>
          <description>intubate using McGrath Videolaryngoscope with 60° angled stylet&#xD;
intubate with 60° angled stylet</description>
        </group>
        <group group_id="E2">
          <title>90°Angle Group</title>
          <description>intubate using McGrath Videolaryngoscope with 90° angled stylet&#xD;
intubate with 60° angled stylet</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jiyoung Lee</name_or_title>
      <organization>Ajou University School of Medicine</organization>
      <phone>82-31-219-5689 ext 667</phone>
      <email>leejiyoung0616@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03000088
org study id: AJIRB-MED-DE4-15-414
nct id: NCT03000088
lead sponsor: 
The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an
      endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this
      study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).
observational model: Case-Control
time perspective: Prospective
measure: Time to Intubation
time frame: 10 minutes around intubation
arm group label: 60° angle group
description: intubate using McGrath Videolaryngoscope with 60° angled stylet
arm group label: 90°angle group
description: intubate using McGrath Videolaryngoscope with 90° angled stylet
intervention type: Device
intervention name: intubate with 60° angled stylet
arm group label: 60° angle group
intervention type: Device
intervention name: intubate with 60° angled stylet
arm group label: 90°angle group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jiyoung Lee, MD
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Jiyoung Lee
investigator title: Clinical assistant prefessor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 