<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/NCT03032263</url>
  </required_header>
  <id_info>
    <org_study_id>CMac-032016</org_study_id>
    <nct_id>NCT03032263</nct_id>
  </id_info>
  <brief_title>Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation</brief_title>
  <official_title>A Comparison of Direct Laryngoscopy and Video Laryngoscopy Using the C-Mac in Pediatric Nasal Intubations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the&#xD;
      oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube&#xD;
      (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward&#xD;
      toward the forehead. This unique shape ensures that the tube will not interfere with surgical&#xD;
      exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea&#xD;
      using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is&#xD;
      possible without an adjuvant, but frequently a pair of specially shaped forceps, known as&#xD;
      Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to&#xD;
      the curvature of these ETT. Magill forceps are introduced into the mouth and are used to&#xD;
      grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the&#xD;
      current literature suggests, it has been our experience that nasal intubations using the&#xD;
      C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This&#xD;
      technique may improve the time and ease to intubation because of not having to use the Magill&#xD;
      forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization&#xD;
      due to obstruction of the view by this tool in the airway, and small working space within the&#xD;
      posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps&#xD;
      because the investigators are using a C-Mac as the only tool to intubate is a potentially&#xD;
      inviting one.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to compare the need for the use of standard Magill forceps&#xD;
      when performing a nasal intubation with either conventional DL or VL with a C-Mac.&#xD;
      Secondarily the investigators will also examine the time to intubate (TTI) for both methods&#xD;
      as well.&#xD;
&#xD;
      Once the patient is recruited, the patient will then be randomized to either intubation using&#xD;
      DL or VL with a C-Mac. Once the patient is under anesthesia, the intubation will be performed&#xD;
      by an attending pediatric anesthesiologist or experience pediatric CRNA who has experience&#xD;
      both DL and with the C-Mac and will attempt to intubate the patient with or without Magill&#xD;
      forceps as needed.&#xD;
&#xD;
      The investigators will record the time to intubation (TTI) from the time the laryngoscope or&#xD;
      C-Mac is placed in the mouth to the first appearance of end tidal carbon dioxide (ETCO2). the&#xD;
      investigators will record the presence or absence of nasal bleeding, and the grade of&#xD;
      laryngeal view. The investigators will also record any general narrative comments about the&#xD;
      ease or difficulty of intubation in both groups.&#xD;
&#xD;
      The study will be performed at Wake Forest Baptist Medical Center.&#xD;
&#xD;
      Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment under&#xD;
      general anesthesia will be included.&#xD;
&#xD;
      Normal appearing airway upon pre-operative assessment. The investigators have calculated a&#xD;
      sample size of 35 patients in each group to be able to detect a significant difference in the&#xD;
      rate of use of Magill forceps to place a nasal RAE ETT in this patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough participants enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">August 7, 2017</completion_date>
  <primary_completion_date type="Actual">August 7, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Requiring Use of Magill Forceps for Nasal Intubations</measure>
    <time_frame>1 day</time_frame>
    <description>Reported as the number and percentage of participants that needed the use of Magill forceps during intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Intubation</measure>
    <time_frame>1 day</time_frame>
    <description>Reported as the average time it took to intubate (seconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade of Larynx View</measure>
    <time_frame>1 day</time_frame>
    <description>Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Nasal Bleeding</measure>
    <time_frame>1 day</time_frame>
    <description>Number of participants that experienced nasal bleeding was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Failed Nasal Intubation</measure>
    <time_frame>1 day</time_frame>
    <description>The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Nasal Intubation</condition>
  <arm_group>
    <arm_group_label>Direct Laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Laryngoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Video Laryngoscopy for nasal intubation</intervention_name>
    <description>The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
    <arm_group_label>Video Laryngoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Direct Laryngoscopy</intervention_name>
    <description>These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
    <arm_group_label>Direct Laryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment&#xD;
             under general anesthesia&#xD;
&#xD;
          -  Normal appearing airway upon pre-operative assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a history of difficult airway/intubation&#xD;
&#xD;
          -  Patients suspected to have a difficult airway&#xD;
&#xD;
          -  History of cleft palate and/or cleft palate repair&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Emergency status of surgery&#xD;
&#xD;
          -  Any patient with a contra-indication to nasal tube placement&#xD;
&#xD;
          -  Any patient with a potentially increased risk of nasal bleeding from nasal placement&#xD;
             of the ETT i.e. patients on aspirin or other anticoagulants, patient's with hemophilia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas W Templeton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sun Y, Lu Y, Huang Y, Jiang H. Pediatric video laryngoscope versus direct laryngoscope: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Oct;24(10):1056-65. doi: 10.1111/pan.12458. Epub 2014 Jun 24.</citation>
    <PMID>24958249</PMID>
  </reference>
  <results_reference>
    <citation>Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19.</citation>
    <PMID>21244568</PMID>
  </results_reference>
  <results_reference>
    <citation>Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9.</citation>
    <PMID>18635480</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>June 14, 2018</results_first_submitted>
  <results_first_submitted_qc>June 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2018</results_first_posted>
  <last_update_submitted>July 10, 2018</last_update_submitted>
  <last_update_submitted_qc>July 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>March 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03032263/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Direct Laryngoscopy</title>
          <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
        </group>
        <group group_id="P2">
          <title>Video Laryngoscopy</title>
          <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </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>Direct Laryngoscopy</title>
          <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
        </group>
        <group group_id="B2">
          <title>Video Laryngoscopy</title>
          <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </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="6.33" spread="2.16"/>
                    <measurement group_id="B2" value="7.33" spread="4.55"/>
                    <measurement group_id="B3" value="6.83" spread="3.43"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Requiring Use of Magill Forceps for Nasal Intubations</title>
        <description>Reported as the number and percentage of participants that needed the use of Magill forceps during intubation</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Use of Magill Forceps for Nasal Intubations</title>
          <description>Reported as the number and percentage of participants that needed the use of Magill forceps during intubation</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="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Intubation</title>
        <description>Reported as the average time it took to intubate (seconds).</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Intubation</title>
          <description>Reported as the average time it took to intubate (seconds).</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="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.43" spread="81.1"/>
                    <measurement group_id="O2" value="57.1" spread="25.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Grade of Larynx View</title>
        <description>Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Grade of Larynx View</title>
          <description>Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread=".52"/>
                    <measurement group_id="O2" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Nasal Bleeding</title>
        <description>Number of participants that experienced nasal bleeding was recorded.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Nasal Bleeding</title>
          <description>Number of participants that experienced nasal bleeding was recorded.</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="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Failed Nasal Intubation</title>
        <description>The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Failed Nasal Intubation</title>
          <description>The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.</description>
          <units>number of intubations</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Direct Laryngoscopy</title>
          <description>These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy</description>
        </group>
        <group group_id="E2">
          <title>Video Laryngoscopy</title>
          <description>These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.&#xD;
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </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>Dr. Thomas Templeton</name_or_title>
      <organization>Wake Forest University Health Sciences</organization>
      <phone>336-716-4285</phone>
      <email>ttemplet@wakehealth.edu</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/NCT03032263
org study id: CMac-032016
nct id: NCT03032263
lead sponsor: 
has dmc: No
Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the
      oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube
      (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward
      toward the forehead. This unique shape ensures that the tube will not interfere with surgical
      exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea
      using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is
      possible without an adjuvant, but frequently a pair of specially shaped forceps, known as
      Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to
      the curvature of these ETT. Magill forceps are introduced into the mouth and are used to
      grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the
      current literature suggests, it has been our experience that nasal intubations using the
      C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This
      technique may improve the time and ease to intubation because of not having to use the Magill
      forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization
      due to obstruction of the view by this tool in the airway, and small working space within the
      posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps
      because the investigators are using a C-Mac as the only tool to intubate is a potentially
      inviting one.
The objective of this study is to compare the need for the use of standard Magill forceps
      when performing a nasal intubation with either conventional DL or VL with a C-Mac.
      Secondarily the investigators will also examine the time to intubate (TTI) for both methods
      as well.

      Once the patient is recruited, the patient will then be randomized to either intubation using
      DL or VL with a C-Mac. Once the patient is under anesthesia, the intubation will be performed
      by an attending pediatric anesthesiologist or experience pediatric CRNA who has experience
      both DL and with the C-Mac and will attempt to intubate the patient with or without Magill
      forceps as needed.

      The investigators will record the time to intubation (TTI) from the time the laryngoscope or
      C-Mac is placed in the mouth to the first appearance of end tidal carbon dioxide (ETCO2). the
      investigators will record the presence or absence of nasal bleeding, and the grade of
      laryngeal view. The investigators will also record any general narrative comments about the
      ease or difficulty of intubation in both groups.

      The study will be performed at Wake Forest Baptist Medical Center.

      Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment under
      general anesthesia will be included.

      Normal appearing airway upon pre-operative assessment. The investigators have calculated a
      sample size of 35 patients in each group to be able to detect a significant difference in the
      rate of use of Magill forceps to place a nasal RAE ETT in this patient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants Requiring Use of Magill Forceps for Nasal Intubations
time frame: 1 day
description: Reported as the number and percentage of participants that needed the use of Magill forceps during intubation
measure: Time to Intubation
time frame: 1 day
description: Reported as the average time it took to intubate (seconds).
measure: Grade of Larynx View
time frame: 1 day
description: Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).
measure: Presence of Nasal Bleeding
time frame: 1 day
description: Number of participants that experienced nasal bleeding was recorded.
measure: Incidence of Failed Nasal Intubation
time frame: 1 day
description: The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.
arm group label: Direct Laryngoscopy
arm group type: Active Comparator
description: These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.
arm group label: Video Laryngoscopy
arm group type: Experimental
description: These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.
intervention type: Device
intervention name: Video Laryngoscopy for nasal intubation
description: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.
arm group label: Video Laryngoscopy
intervention type: Device
intervention name: Direct Laryngoscopy
description: These patients will be nasally intubated for their procedure via direct laryngoscopy
arm group label: Direct Laryngoscopy
criteria: 
gender: All
minimum age: 3 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas W Templeton, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
citation: Sun Y, Lu Y, Huang Y, Jiang H. Pediatric video laryngoscope versus direct laryngoscope: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Oct;24(10):1056-65. doi: 10.1111/pan.12458. Epub 2014 Jun 24.
PMID: 24958249
citation: Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19.
PMID: 21244568
citation: Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9.
PMID: 18635480
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 