<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/NCT03757091</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0661</org_study_id>
    <secondary_id>NCI-2018-02698</secondary_id>
    <secondary_id>2018-0661</secondary_id>
    <nct_id>NCT03757091</nct_id>
  </id_info>
  <brief_title>Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery</brief_title>
  <official_title>Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well flexible intubation scope with or without video laryngoscope&#xD;
      works in supporting endotracheal tube placement in patients with head and neck cancer before&#xD;
      surgery. Flexible intubation scope and video laryngoscope are devices that have a small&#xD;
      camera to help the doctor see the patient's airway on a screen. Both devices may help the&#xD;
      doctor who gives anesthesia prevent complications from placing the breathing tube (such as&#xD;
      pain or mouth injury).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible&#xD;
      intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in&#xD;
      difficult airway management.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of&#xD;
      the video laryngoscope (VL).&#xD;
&#xD;
      II. Total time for securing the airway.&#xD;
&#xD;
      III. Number of attempts required for intubation.&#xD;
&#xD;
      IV. Rate of failure at intubation.&#xD;
&#xD;
      V. Incidence of desaturation.&#xD;
&#xD;
      VI. Assessment for hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury,&#xD;
      tongue injury, or tooth damage.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM A: Patients undergo flexible scope intubation up to 2 attempts following induction of&#xD;
      general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients&#xD;
      undergo a third attempt utilizing another technique or device.&#xD;
&#xD;
      ARM B: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts&#xD;
      following induction of general anesthesia and adequate manual ventilation. In case of failed&#xD;
      2 attempts, patients undergo a third attempt utilizing another technique or device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of difficult endotracheal tube (ETT) placement</measure>
    <time_frame>1 day</time_frame>
    <description>Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total time for securing the airway</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts required for intubation</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of failure at intubation</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of desaturation</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of difficult Endotracheal Tube (ETT) placement using a flexible intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in difficult airway management.</measure>
    <time_frame>1 day</time_frame>
    <description>For complications, researchers will assign a '0' for no complication arising and a '1' for any complications arising. The total score will range from 0 to 3 and will be summarized using frequencies and percentages related to each level of the total score and using the mean score and standard deviation, whichever is more appropriate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Head and Neck Neoplasm</condition>
  <arm_group>
    <arm_group_label>Arm A (flexible intubation scope)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (flexible intubation scope,video laryngoscope)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngoscopy</intervention_name>
    <description>Undergo video laryngoscopy</description>
    <arm_group_label>Arm B (flexible intubation scope,video laryngoscope)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracheal Intubation</intervention_name>
    <description>Undergo flexible scope intubation</description>
    <arm_group_label>Arm A (flexible intubation scope)</arm_group_label>
    <arm_group_label>Arm B (flexible intubation scope,video laryngoscope)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages ≥ 18 years of age&#xD;
&#xD;
          -  All surgical patients with known or suspected difficult airways that meet at least&#xD;
             three (3) of the Difficult Airway criteria [Mallampati III-IV, Neck circumference &gt; 40&#xD;
             cm, Sternomental distance &lt; 12 cm, Thyromental distance &lt; 6 cm, Mouth opening &lt; 4 cm,&#xD;
             BMI ≥ 35 kg/m2, Upper Lip Bite Test - ULBT (class III)] or history of radiation to the&#xD;
             head and neck area or oral pathology obstructing the glottic view&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) I-IV&#xD;
&#xD;
          -  Has provided written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bleeding from nasopharynx or oropharynx&#xD;
&#xD;
          -  Trismus&#xD;
&#xD;
          -  Oral pathology obstructing the glottic view&#xD;
&#xD;
          -  Planned awake or nasal intubation&#xD;
&#xD;
          -  Neuromuscular Blockade (NMB) contraindicated post-induction&#xD;
&#xD;
          -  Emergency endotracheal intubation and patients intubated pre and post-surgery&#xD;
&#xD;
          -  Surgical procedures such as Tracheostomy, Laryngectomy, Esophagectomy&#xD;
&#xD;
          -  Patient refusal or inability to consent for study participation&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) V&#xD;
&#xD;
          -  Pregnant females&#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 Hagberg</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carin Hagberg</last_name>
    <phone>713-563-0223</phone>
    <email>chagberg@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carin A. Hagberg</last_name>
      <phone>713-563-0223</phone>
    </contact>
    <investigator>
      <last_name>Carin A. Hagberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03757091
org study id: 2018-0661
secondary id: NCI-2018-02698
secondary id: 2018-0661
nct id: NCT03757091
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This trial studies how well flexible intubation scope with or without video laryngoscope
      works in supporting endotracheal tube placement in patients with head and neck cancer before
      surgery. Flexible intubation scope and video laryngoscope are devices that have a small
      camera to help the doctor see the patient's airway on a screen. Both devices may help the
      doctor who gives anesthesia prevent complications from placing the breathing tube (such as
      pain or mouth injury).
PRIMARY OBJECTIVES:

      I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible
      intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in
      difficult airway management.

      SECONDARY OBJECTIVES:

      I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of
      the video laryngoscope (VL).

      II. Total time for securing the airway.

      III. Number of attempts required for intubation.

      IV. Rate of failure at intubation.

      V. Incidence of desaturation.

      VI. Assessment for hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury,
      tongue injury, or tooth damage.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM A: Patients undergo flexible scope intubation up to 2 attempts following induction of
      general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients
      undergo a third attempt utilizing another technique or device.

      ARM B: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts
      following induction of general anesthesia and adequate manual ventilation. In case of failed
      2 attempts, patients undergo a third attempt utilizing another technique or device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rates of difficult endotracheal tube (ETT) placement
time frame: 1 day
description: Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.
measure: Total time for securing the airway
time frame: 1 day
measure: Number of attempts required for intubation
time frame: 1 day
measure: Rate of failure at intubation
time frame: 1 day
measure: Incidence of desaturation
time frame: 1 day
measure: Complications of difficult Endotracheal Tube (ETT) placement using a flexible intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in difficult airway management.
time frame: 1 day
description: For complications, researchers will assign a '0' for no complication arising and a '1' for any complications arising. The total score will range from 0 to 3 and will be summarized using frequencies and percentages related to each level of the total score and using the mean score and standard deviation, whichever is more appropriate.
arm group label: Arm A (flexible intubation scope)
arm group type: Active Comparator
description: Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.
arm group label: Arm B (flexible intubation scope,video laryngoscope)
arm group type: Experimental
description: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.
intervention type: Device
intervention name: Laryngoscopy
description: Undergo video laryngoscopy
arm group label: Arm B (flexible intubation scope,video laryngoscope)
intervention type: Procedure
intervention name: Tracheal Intubation
description: Undergo flexible scope intubation
arm group label: Arm A (flexible intubation scope)
arm group label: Arm B (flexible intubation scope,video laryngoscope)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carin Hagberg
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Carin Hagberg
phone: 713-563-0223
email: chagberg@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms