<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/NCT03265938</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-0963</org_study_id>
    <nct_id>NCT03265938</nct_id>
  </id_info>
  <brief_title>Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology</brief_title>
  <official_title>Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who undergo general anesthesia for surgical procedures frequently need to have a&#xD;
      breathing tube placed (&quot;tracheal intubation&quot;) for the duration of the procedure. Most often&#xD;
      airway management is routine for an experienced anesthesiologist. Less often, airway&#xD;
      management can be difficult and can result in patient harm. In order to reduce risk,&#xD;
      anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and&#xD;
      doing a physical exam, which can aid in predicting which airways may be difficult to manage.&#xD;
      The &quot;gold standard&quot; for management of the anticipated difficult airway is to perform an awake&#xD;
      flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This&#xD;
      affords added safety because the airway remains patent and the patient breaths spontaneously&#xD;
      until a tracheal tube is secured, at which point general anesthesia can be induced.&#xD;
&#xD;
      Recently, authors have advocated for alternative methods of management of the predicted&#xD;
      difficult airway, most commonly by using a video laryngoscope to perform the awake&#xD;
      intubation. A video laryngoscope provides an indirect view of the larynx using a camera at&#xD;
      the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency&#xD;
      compared to flexible bronchoscopy.&#xD;
&#xD;
      Previous studies that have shown successful awake intubation with video laryngoscopy in the&#xD;
      predicted difficult airway have not included patients with head and neck pathology, including&#xD;
      malignancies or a history of head and neck surgery or radiation. In this study, the study&#xD;
      team will perform video laryngoscopy in patients with head and neck pathology who require&#xD;
      awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction&#xD;
      of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of&#xD;
      the larynx with video laryngoscopy in some patients with head and neck pathology. If there is&#xD;
      a significant incidence of difficult video laryngoscopy in this patient population, it will&#xD;
      reinforce that anesthesiologists need to continue to learn and maintain skills in&#xD;
      bronchoscopic intubation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 24, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Cormack-Lehane Grade &gt;2 Obtained With CMAC D Blade</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of participants with difficult (Cormack-Lehane grade &gt;2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC&#xD;
Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Cormack-Lehane Grade &gt;2 Obtained With Glidescope AVL</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of participants with difficult (Cormack-Lehane grade &gt;2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL&#xD;
Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane Grade Obtained With CMAC D Blade</measure>
    <time_frame>Day 1</time_frame>
    <description>Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane Grade Obtained With Glidescope AVL</measure>
    <time_frame>Day 1</time_frame>
    <description>Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade</measure>
    <time_frame>Day 1</time_frame>
    <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL</measure>
    <time_frame>Day 1</time_frame>
    <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade</measure>
    <time_frame>Day 1</time_frame>
    <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL</measure>
    <time_frame>Day 1</time_frame>
    <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Difficult Intubation</condition>
  <arm_group>
    <arm_group_label>Indirect laryngoscopy</arm_group_label>
    <description>Head and neck pathology patients undergoing indirect laryngoscopy. Patients with a past medical history of active or previously treated head and neck pathology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indirect Laryngoscopy</intervention_name>
    <description>The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.</description>
    <arm_group_label>Indirect laryngoscopy</arm_group_label>
    <other_name>Glidescope AVL Indirect Laryngoscopy</other_name>
    <other_name>C-MAC D-Blade Indirect Laryngoscopy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all patients scheduled to undergo a surgical procedure at&#xD;
        the Mount Sinai Hospital (New York, NY)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years old&#xD;
&#xD;
          -  Presence of oral, pharyngeal or laryngeal mass or history of surgery or radiation for&#xD;
             head and neck cancer&#xD;
&#xD;
          -  Requiring awake flexible bronchoscopic intubation for surgery&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency Procedure&#xD;
&#xD;
          -  Presence of one or more loose teeth&#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>Jaime Hyman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.</citation>
    <PMID>23364566</PMID>
  </reference>
  <reference>
    <citation>Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia. 2016 Jan;71(1):12-6. doi: 10.1111/anae.13333. No abstract available.</citation>
    <PMID>26684527</PMID>
  </reference>
  <reference>
    <citation>Kramer A, Muller D, Pfortner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC((R)) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016.</citation>
    <PMID>25764403</PMID>
  </reference>
  <reference>
    <citation>Rosenstock CV, Thogersen B, Afshari A, Christensen AL, Eriksen C, Gatke MR. Awake fiberoptic or awake video laryngoscopic tracheal intubation in patients with anticipated difficult airway management: a randomized clinical trial. Anesthesiology. 2012 Jun;116(6):1210-6. doi: 10.1097/ALN.0b013e318254d085.</citation>
    <PMID>22487805</PMID>
  </reference>
  <reference>
    <citation>Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.</citation>
    <PMID>21150569</PMID>
  </reference>
  <reference>
    <citation>Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.</citation>
    <PMID>21447488</PMID>
  </reference>
  <reference>
    <citation>Fiadjoe JE, Litman RS. Difficult tracheal intubation: looking to the past to determine the future. Anesthesiology. 2012 Jun;116(6):1181-2. doi: 10.1097/ALN.0b013e318254d0a0. No abstract available.</citation>
    <PMID>22487804</PMID>
  </reference>
  <reference>
    <citation>Popat MT, Srivastava M, Russell R. Awake fibreoptic intubation skills in obstetric patients: a survey of anaesthetists in the Oxford region. Int J Obstet Anesth. 2000 Apr;9(2):78-82. doi: 10.1054/ijoa.1999.0361.</citation>
    <PMID>15321093</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>June 1, 2020</results_first_submitted>
  <results_first_submitted_qc>June 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2020</results_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Jaime B Hyman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Head and Neck cancer</keyword>
  <keyword>Cancer of oral cavity</keyword>
  <keyword>Ear, Nose and Throat</keyword>
  <keyword>Indirect laryngoscopy</keyword>
  <keyword>Awake intubation</keyword>
  <keyword>Expected difficult intubation</keyword>
  <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 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03265938/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>study was conducted from September 2017 until July 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Indirect Laryngoscopy</title>
          <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.</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="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>friable mass</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Indirect Laryngoscopy</title>
          <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.</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>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <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>
                  <measurement_list>
                    <measurement group_id="B1" value="65" lower_limit="56.25" upper_limit="71.5"/>
                  </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="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <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>
                  <measurement_list>
                    <measurement group_id="B1" value="23.79" lower_limit="21.67" upper_limit="27.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Head and Neck Surgery</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>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Radiation Therapy</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>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Edentulous</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>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mallampati score</title>
          <description>the Mallampati score (or Mallampati classification) is used to predict the ease of intubation.&#xD;
Complete visualization of the soft palate&#xD;
Complete visualization of the uvula&#xD;
Visualization of only the base of the uvula&#xD;
Soft palate is not visible at all</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Head and Neck Mass Location</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Base of Tongue</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supraglottic</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neck</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Laryngeal</title>
              <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>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Cormack-Lehane Grade &gt;2 Obtained With CMAC D Blade</title>
        <description>Number of participants with difficult (Cormack-Lehane grade &gt;2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC&#xD;
Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cormack-Lehane Grade &gt;2 Obtained With CMAC D Blade</title>
          <description>Number of participants with difficult (Cormack-Lehane grade &gt;2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC&#xD;
Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</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="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Cormack-Lehane Grade &gt;2 Obtained With Glidescope AVL</title>
        <description>Number of participants with difficult (Cormack-Lehane grade &gt;2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL&#xD;
Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the GlideScope AVL video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cormack-Lehane Grade &gt;2 Obtained With Glidescope AVL</title>
          <description>Number of participants with difficult (Cormack-Lehane grade &gt;2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL&#xD;
Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</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="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cormack-Lehane Grade Obtained With CMAC D Blade</title>
        <description>Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Cormack-Lehane Grade Obtained With CMAC D Blade</title>
          <description>Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</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="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cormack-Lehane Grade Obtained With Glidescope AVL</title>
        <description>Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the GlideScope AVL video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Cormack-Lehane Grade Obtained With Glidescope AVL</title>
          <description>Cormack-Lehane grade in patients with head and neck pathology of the larynx.&#xD;
Cormack-Lehane grade:&#xD;
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified</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="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade</title>
        <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.</description>
        <time_frame>Day 1</time_frame>
        <population>Data for participants who have a history of head and neck masses.</population>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade</title>
          <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.</description>
          <population>Data for participants who have a history of head and neck masses.</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="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL</title>
        <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.</description>
        <time_frame>Day 1</time_frame>
        <population>Data for participants who have a history of head and neck masses.</population>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the GlideScope AVL video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL</title>
          <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.</description>
          <population>Data for participants who have a history of head and neck masses.</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="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <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>Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade</title>
        <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.</description>
        <time_frame>Day 1</time_frame>
        <population>Data for participants who have a history of neck radiation</population>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the C-MAC D video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade</title>
          <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.</description>
          <population>Data for participants who have a history of neck radiation</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="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL</title>
        <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.</description>
        <time_frame>Day 1</time_frame>
        <population>Data for participants who have a history of neck radiation.</population>
        <group_list>
          <group group_id="O1">
            <title>Indirect Laryngoscopy</title>
            <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist performed video laryngoscopy with the GlideScope AVL video laryngoscope and graded the view of the larynx.</description>
          </group>
        </group_list>
        <measure>
          <title>Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL</title>
          <description>Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.</description>
          <population>Data for participants who have a history of neck radiation.</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="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2a</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2b</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </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>Indirect Laryngoscopy</title>
          <description>Head and neck pathology patients undergoing indirect laryngoscopy. Indirect Laryngoscopy: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.</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="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was not a comparison between awake techniques. Laryngoscopy conditions may be different after an endotracheal tube is already in place and the patient is anesthetized. The results cannot be generalized to other available types.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Samuel DeMaria</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>(212) 241-1518</phone>
      <email>samuel.demaria@mountsinai.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265938
org study id: GCO 17-0963
nct id: NCT03265938
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Patients who undergo general anesthesia for surgical procedures frequently need to have a
      breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often
      airway management is routine for an experienced anesthesiologist. Less often, airway
      management can be difficult and can result in patient harm. In order to reduce risk,
      anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and
      doing a physical exam, which can aid in predicting which airways may be difficult to manage.
      The "gold standard" for management of the anticipated difficult airway is to perform an awake
      flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This
      affords added safety because the airway remains patent and the patient breaths spontaneously
      until a tracheal tube is secured, at which point general anesthesia can be induced.

      Recently, authors have advocated for alternative methods of management of the predicted
      difficult airway, most commonly by using a video laryngoscope to perform the awake
      intubation. A video laryngoscope provides an indirect view of the larynx using a camera at
      the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency
      compared to flexible bronchoscopy.

      Previous studies that have shown successful awake intubation with video laryngoscopy in the
      predicted difficult airway have not included patients with head and neck pathology, including
      malignancies or a history of head and neck surgery or radiation. In this study, the study
      team will perform video laryngoscopy in patients with head and neck pathology who require
      awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction
      of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of
      the larynx with video laryngoscopy in some patients with head and neck pathology. If there is
      a significant incidence of difficult video laryngoscopy in this patient population, it will
      reinforce that anesthesiologists need to continue to learn and maintain skills in
      bronchoscopic intubation.
observational model: Case-Only
time perspective: Prospective
measure: Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade
time frame: Day 1
description: Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC
Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
measure: Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL
time frame: Day 1
description: Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL
Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
measure: Cormack-Lehane Grade Obtained With CMAC D Blade
time frame: Day 1
description: Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
measure: Cormack-Lehane Grade Obtained With Glidescope AVL
time frame: Day 1
description: Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
measure: Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
time frame: Day 1
description: Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
measure: Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
time frame: Day 1
description: Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
measure: Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
time frame: Day 1
description: Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
measure: Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
time frame: Day 1
description: Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
arm group label: Indirect laryngoscopy
description: Head and neck pathology patients undergoing indirect laryngoscopy. Patients with a past medical history of active or previously treated head and neck pathology.
intervention type: Device
intervention name: Indirect Laryngoscopy
description: The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.
arm group label: Indirect laryngoscopy
other name: Glidescope AVL Indirect Laryngoscopy
other name: C-MAC D-Blade Indirect Laryngoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jaime Hyman, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
citation: Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PMID: 23364566
citation: Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia. 2016 Jan;71(1):12-6. doi: 10.1111/anae.13333. No abstract available.
PMID: 26684527
citation: Kramer A, Muller D, Pfortner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC((R)) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016.
PMID: 25764403
citation: Rosenstock CV, Thogersen B, Afshari A, Christensen AL, Eriksen C, Gatke MR. Awake fiberoptic or awake video laryngoscopic tracheal intubation in patients with anticipated difficult airway management: a randomized clinical trial. Anesthesiology. 2012 Jun;116(6):1210-6. doi: 10.1097/ALN.0b013e318254d085.
PMID: 22487805
citation: Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PMID: 21150569
citation: Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
PMID: 21447488
citation: Fiadjoe JE, Litman RS. Difficult tracheal intubation: looking to the past to determine the future. Anesthesiology. 2012 Jun;116(6):1181-2. doi: 10.1097/ALN.0b013e318254d0a0. No abstract available.
PMID: 22487804
citation: Popat MT, Srivastava M, Russell R. Awake fibreoptic intubation skills in obstetric patients: a survey of anaesthetists in the Oxford region. Int J Obstet Anesth. 2000 Apr;9(2):78-82. doi: 10.1054/ijoa.1999.0361.
PMID: 15321093
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Jaime B Hyman
investigator title: Assistant Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was not a comparison between awake techniques. Laryngoscopy conditions may be different after an endotracheal tube is already in place and the patient is anesthetized. The results cannot be generalized to other available types.
point of contact: 