<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/NCT02250521</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-14-0365</org_study_id>
    <nct_id>NCT02250521</nct_id>
  </id_info>
  <brief_title>McGRATH MAC Video Laryngoscope</brief_title>
  <official_title>McGRATH MAC Video Laryngoscope - To View or Not To View?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to determine the first attempt success rate of tracheal intubation&#xD;
      with the McGRATH™ MAC laryngoscope using direct visualization in patients with known&#xD;
      difficult airways, as well as exploring the possibility of identifying a particular direct&#xD;
      Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial&#xD;
      during laryngoscopy and intubation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View</measure>
    <time_frame>after successful endotracheal tube placement</time_frame>
    <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glottic View With Direct Laryngoscopy</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glottic View With Indirect Laryngoscopy</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Direct View Laryngoscopy During the First Attempt</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>Time from mouth opening to best direct laryngoscopic view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Indirect View Laryngoscopy During the First Attempt</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>Time from mouth opening to best indirect laryngoscopic view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Intubation</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Intubation Attempts</measure>
    <time_frame>at the time of intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received External Laryngeal Manipulation During the First Attempt</measure>
    <time_frame>at the time of intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt</measure>
    <time_frame>at the time of intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ease of Laryngoscopy</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as &quot;very easy,&quot; &quot;easy,&quot; &quot;slight resistance,&quot; &quot;difficult,&quot; or &quot;not possible.&quot; The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ease of Intubation</measure>
    <time_frame>at the time of laryngoscopy</time_frame>
    <description>The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as &quot;very easy,&quot; &quot;easy,&quot; &quot;slight resistance,&quot; &quot;difficult,&quot; or &quot;not possible.&quot; The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Intubation; Difficult</condition>
  <arm_group>
    <arm_group_label>McGrath Mac intubations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>McGrath MAC enhanced direct laryngoscope</intervention_name>
    <description>The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view.&#xD;
All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
    <arm_group_label>McGrath Mac intubations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &lt; 50 kg/m2&#xD;
&#xD;
          -  Two or more of the following inclusion criteria: Mallampati class: III-IV; Reduced&#xD;
             mouth opening &lt; 4 cm; Neck circumference &gt; 40 cm for females and &gt; 43 cm for males;&#xD;
             Thyromental distance &lt; 6 cm; Ratio of the patient's height to thyromental distance ≥&#xD;
             23.5; Sternomental distance &lt; 12 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 50 kg/m2&#xD;
&#xD;
          -  emergency status&#xD;
&#xD;
          -  cervical injury or pathology&#xD;
&#xD;
          -  neck irradiation&#xD;
&#xD;
          -  known difficult airway&#xD;
&#xD;
          -  risk of gastric aspiration&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  requiring rapid sequence intubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carin A Hagberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.medtronic.com/covidien/en-us/products/intubation/mcgrath-mac-video-laryngoscope.html</url>
    <description>Device information</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>February 14, 2018</results_first_submitted>
  <results_first_submitted_qc>October 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2018</results_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BMI &lt; 50 kg/m2</keyword>
  <keyword>Mallampatti class: III-IV</keyword>
  <keyword>Reduced mouth opening &lt; 4 cm</keyword>
  <keyword>Neck circumference &gt; 40 cm for females and &gt; 43 cm for males</keyword>
  <keyword>Thyromental distance &lt; 6 cm</keyword>
  <keyword>Ratio of the patient's height to thyromental distance ≥ 23.5</keyword>
  <keyword>Sternomental distance &lt; 12 cm</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>McGrath Mac Intubations</title>
          <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>McGrath Mac Intubations</title>
          <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age is reported not for 100 subjects, but only for the 94 who were analyzed. Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.17" spread="14.70"/>
                  </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="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View</title>
        <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
        <time_frame>after successful endotracheal tube placement</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View</title>
          <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>direct laryngoscopic view</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>indirect laryngoscopic view</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glottic View With Direct Laryngoscopy</title>
        <description>Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Glottic View With Direct Laryngoscopy</title>
          <description>Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 1 view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2a view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2b view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3 view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4 view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glottic View With Indirect Laryngoscopy</title>
        <description>Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Glottic View With Indirect Laryngoscopy</title>
          <description>Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 1 view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2b view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2a view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3 view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4 view</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Direct View Laryngoscopy During the First Attempt</title>
        <description>Time from mouth opening to best direct laryngoscopic view</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 78 of the 94 analyzed had direct laryngoscopy, and thus 78 are analyzed in this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Direct View Laryngoscopy During the First Attempt</title>
          <description>Time from mouth opening to best direct laryngoscopic view</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 78 of the 94 analyzed had direct laryngoscopy, and thus 78 are analyzed in this outcome measure.</population>
          <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="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.41" spread="7.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Indirect View Laryngoscopy During the First Attempt</title>
        <description>Time from mouth opening to best indirect laryngoscopic view</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 16 of the 94 analyzed had direct laryngoscopy, and thus 16 are analyzed in this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Indirect View Laryngoscopy During the First Attempt</title>
          <description>Time from mouth opening to best indirect laryngoscopic view</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 16 of the 94 analyzed had direct laryngoscopy, and thus 16 are analyzed in this outcome measure.</population>
          <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="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.73" spread="9.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Intubation</title>
        <description>Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Intubation</title>
          <description>Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <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="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.91" spread="22.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Intubation Attempts</title>
        <time_frame>at the time of intubation</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Intubation Attempts</title>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 attempt</title>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 attempts</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 attempts</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received External Laryngeal Manipulation During the First Attempt</title>
        <time_frame>at the time of intubation</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received External Laryngeal Manipulation During the First Attempt</title>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt</title>
        <time_frame>at the time of intubation</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt</title>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Ease of Laryngoscopy</title>
        <description>The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as &quot;very easy,&quot; &quot;easy,&quot; &quot;slight resistance,&quot; &quot;difficult,&quot; or &quot;not possible.&quot; The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained.</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ease of Laryngoscopy</title>
          <description>The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as &quot;very easy,&quot; &quot;easy,&quot; &quot;slight resistance,&quot; &quot;difficult,&quot; or &quot;not possible.&quot; The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained.</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>slight resistance</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not possible</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Ease of Intubation</title>
        <description>The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as &quot;very easy,&quot; &quot;easy,&quot; &quot;slight resistance,&quot; &quot;difficult,&quot; or &quot;not possible.&quot; The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords.</description>
        <time_frame>at the time of laryngoscopy</time_frame>
        <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
        <group_list>
          <group group_id="O1">
            <title>McGrath Mac Intubations</title>
            <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ease of Intubation</title>
          <description>The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as &quot;very easy,&quot; &quot;easy,&quot; &quot;slight resistance,&quot; &quot;difficult,&quot; or &quot;not possible.&quot; The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords.</description>
          <population>Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>very easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>easy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>slight resistance</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not possible</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients enter the PACU within 30 minutes of completion of surgery, and they leave the PACU approximately 1-2 hours after entering the PACU.</time_frame>
      <desc>All 100 patients were assessed for SAEs. 94 patients were assessed for other AEs (not including SAEs): 6 patients were excluded from data analysis; 4 patients were found to not meet inclusion criteria; one patient with glottic view grade 3 was erroneously intubated via the indirect method; and for another patient, the anesthesiologist aborted the protocol due to encountered difficulties.</desc>
      <group_list>
        <group group_id="E1">
          <title>McGrath Mac Intubations</title>
          <description>All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.</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="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" events="41" subjects_affected="41" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Sore mouth</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>sore neck</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Sore jaw</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Alteration in Tongue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </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>Carin A. Hagberg, MD</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>713-500-6200</phone>
      <email>Carin.A.Hagberg@uth.tmc.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/NCT02250521
org study id: HSC-MS-14-0365
nct id: NCT02250521
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study was designed to determine the first attempt success rate of tracheal intubation
      with the McGRATH™ MAC laryngoscope using direct visualization in patients with known
      difficult airways, as well as exploring the possibility of identifying a particular direct
      Cormack-Lehane (C-L) grade view where indirect (video) visualization can be most beneficial
      during laryngoscopy and intubation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View
time frame: after successful endotracheal tube placement
description: All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
measure: Glottic View With Direct Laryngoscopy
time frame: at the time of laryngoscopy
description: Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible
measure: Glottic View With Indirect Laryngoscopy
time frame: at the time of laryngoscopy
description: Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible
measure: Time for Direct View Laryngoscopy During the First Attempt
time frame: at the time of laryngoscopy
description: Time from mouth opening to best direct laryngoscopic view
measure: Time for Indirect View Laryngoscopy During the First Attempt
time frame: at the time of laryngoscopy
description: Time from mouth opening to best indirect laryngoscopic view
measure: Time for Intubation
time frame: at the time of laryngoscopy
description: Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.
measure: Number of Intubation Attempts
time frame: at the time of intubation
measure: Number of Participants Who Received External Laryngeal Manipulation During the First Attempt
time frame: at the time of intubation
measure: Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt
time frame: at the time of intubation
measure: Subjective Ease of Laryngoscopy
time frame: at the time of laryngoscopy
description: The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained.
measure: Subjective Ease of Intubation
time frame: at the time of laryngoscopy
description: The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as "very easy," "easy," "slight resistance," "difficult," or "not possible." The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords.
arm group label: McGrath Mac intubations
arm group type: Experimental
description: All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The liquid crystal display (LCD) monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
intervention type: Device
intervention name: McGrath MAC enhanced direct laryngoscope
description: The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view.
All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.
arm group label: McGrath Mac intubations
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carin A Hagberg, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
url: http://www.medtronic.com/covidien/en-us/products/intubation/mcgrath-mac-video-laryngoscope.html
description: Device information
responsible party type: Sponsor
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 