<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/NCT02991820</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-00549</org_study_id>
    <nct_id>NCT02991820</nct_id>
  </id_info>
  <brief_title>VL vs DL in Inexperienced Users: a Pediatric Manikin Study</brief_title>
  <official_title>Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph D. Tobias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct&#xD;
      laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance&#xD;
      of users. This will involve the use of an intubating pediatric manikin to assess various&#xD;
      aspects of endotracheal intubation by experienced and inexperienced users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The commonly used method for endotracheal intubation in children is direct laryngoscopy using&#xD;
      a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway&#xD;
      management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to&#xD;
      align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct&#xD;
      view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for&#xD;
      learners as they can visualize all the anatomical structures of larynx at the same time with&#xD;
      the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced&#xD;
      users in the pediatric population. There are limited data on the use of videolaryngoscopes by&#xD;
      anesthesia providers and medical personnel who are inexperienced in the use of&#xD;
      videolaryngoscopes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Endotracheal Intubation</measure>
    <time_frame>the same day (within seconds to minutes)</time_frame>
    <description>The amount of time it took to successfully intubate the manikin using each device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful Intubation Within 120 Seconds</measure>
    <time_frame>2 minutes</time_frame>
    <description>The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Videolaryngoscopes (VL)</condition>
  <condition>Direct Laryngoscopy (DL)</condition>
  <condition>Inexperienced Users</condition>
  <arm_group>
    <arm_group_label>Inexperienced users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experienced users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experienced users will include faculty pediatric anesthesiologists CRNAs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Miller</intervention_name>
    <description>Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope</description>
    <arm_group_label>Experienced users</arm_group_label>
    <arm_group_label>Inexperienced users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Macintosh</intervention_name>
    <description>Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope</description>
    <arm_group_label>Experienced users</arm_group_label>
    <arm_group_label>Inexperienced users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>C-MAC</intervention_name>
    <description>Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope</description>
    <arm_group_label>Experienced users</arm_group_label>
    <arm_group_label>Inexperienced users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GlideScope</intervention_name>
    <description>Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope</description>
    <arm_group_label>Experienced users</arm_group_label>
    <arm_group_label>Inexperienced users</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Faculty pediatric anesthesiologists&#xD;
&#xD;
          -  CRNAs&#xD;
&#xD;
          -  Trainees (SRNAs, residents, fellows, and medical students)&#xD;
&#xD;
          -  Nurses from NCH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If subjects are unwilling to participate.&#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>Joseph Tobias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>February 6, 2018</results_first_submitted>
  <results_first_submitted_qc>July 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2018</results_first_posted>
  <last_update_submitted>July 17, 2018</last_update_submitted>
  <last_update_submitted_qc>July 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Joseph D. Tobias</investigator_full_name>
    <investigator_title>Chairman, Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT02991820/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Inexperienced Users</title>
          <description>Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
        </group>
        <group group_id="P2">
          <title>Experienced Users</title>
          <description>Experienced users will include faculty pediatric anesthesiologists CRNAs.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="31"/>
              </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>Inexperienced Users</title>
          <description>Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
        </group>
        <group group_id="B2">
          <title>Experienced Users</title>
          <description>Experienced users will include faculty pediatric anesthesiologists CRNAs.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</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="12"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">was not assessed</measurement>
                    <measurement group_id="B2" value="NA">was not assessed</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">was not assessed</measurement>
                    <measurement group_id="B2" value="NA">was not assessed</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Endotracheal Intubation</title>
        <description>The amount of time it took to successfully intubate the manikin using each device.</description>
        <time_frame>the same day (within seconds to minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inexperienced Users</title>
            <description>Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
          </group>
          <group group_id="O2">
            <title>Experienced Users</title>
            <description>Experienced users will include faculty pediatric anesthesiologists CRNAs.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Endotracheal Intubation</title>
          <description>The amount of time it took to successfully intubate the manikin using each device.</description>
          <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="12"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Miller</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="45"/>
                    <measurement group_id="O2" value="30" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Macintosh</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="45"/>
                    <measurement group_id="O2" value="27" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C-Mac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" spread="34"/>
                    <measurement group_id="O2" value="20" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GlideScope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118" spread="6"/>
                    <measurement group_id="O2" value="85" spread="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Successful Intubation Within 120 Seconds</title>
        <description>The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.</description>
        <time_frame>2 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Inexperienced Users</title>
            <description>Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.&#xD;
Miller: Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope&#xD;
Macintosh: Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope&#xD;
C-MAC: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope&#xD;
GlideScope: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope</description>
          </group>
          <group group_id="O2">
            <title>Experienced Users</title>
            <description>Experienced users will include faculty pediatric anesthesiologists CRNAs.&#xD;
Miller: Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope&#xD;
Macintosh: Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope&#xD;
C-MAC: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope&#xD;
GlideScope: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Successful Intubation Within 120 Seconds</title>
          <description>The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Miller</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Macintosh</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C-Mac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GlideScope</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <desc>All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Inexperienced Users</title>
          <description>Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
        </group>
        <group group_id="E2">
          <title>Experienced Users</title>
          <description>Experienced users will include faculty pediatric anesthesiologists CRNAs.&#xD;
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Joseph D. Tobias, MD</name_or_title>
      <organization>Nationwide Children's Hospital</organization>
      <phone>6147224200</phone>
      <email>Joseph.Tobias@nationwidechildrens.org</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/NCT02991820
org study id: IRB16-00549
nct id: NCT02991820
lead sponsor: 
has dmc: No
This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct
      laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance
      of users. This will involve the use of an intubating pediatric manikin to assess various
      aspects of endotracheal intubation by experienced and inexperienced users.
The commonly used method for endotracheal intubation in children is direct laryngoscopy using
      a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway
      management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to
      align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct
      view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for
      learners as they can visualize all the anatomical structures of larynx at the same time with
      the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced
      users in the pediatric population. There are limited data on the use of videolaryngoscopes by
      anesthesia providers and medical personnel who are inexperienced in the use of
      videolaryngoscopes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
measure: Time to Endotracheal Intubation
time frame: the same day (within seconds to minutes)
description: The amount of time it took to successfully intubate the manikin using each device.
measure: Successful Intubation Within 120 Seconds
time frame: 2 minutes
description: The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.
arm group label: Inexperienced users
arm group type: Experimental
description: Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
arm group label: Experienced users
arm group type: Experimental
description: Experienced users will include faculty pediatric anesthesiologists CRNAs.
intervention type: Device
intervention name: Miller
description: Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope
arm group label: Experienced users
arm group label: Inexperienced users
intervention type: Device
intervention name: Macintosh
description: Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope
arm group label: Experienced users
arm group label: Inexperienced users
intervention type: Device
intervention name: C-MAC
description: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope
arm group label: Experienced users
arm group label: Inexperienced users
intervention type: Device
intervention name: GlideScope
description: Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope
arm group label: Experienced users
arm group label: Inexperienced users
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph Tobias, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Joseph D. Tobias
investigator title: Chairman, Professor of Anesthesiology
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 