<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/NCT02210338</url>
  </required_header>
  <id_info>
    <org_study_id>sghan-cb01</org_study_id>
    <nct_id>NCT02210338</nct_id>
  </id_info>
  <brief_title>A Comparison of the C-mac and Bonfils Intubation Fibrescope</brief_title>
  <official_title>A Comparison of the C-mac and Bonfils Intubation Fibrescope for Tracheal Intubation in Patients With a Simulated Difficult Airway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to determine the better device to facilitate intubation in patients with a&#xD;
      limited neck movement and small mouth opening. This may help anesthesiology as well as&#xD;
      emergency medicine practitioners and departments to decide when choosing between these two&#xD;
      conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior&#xD;
      when compared to the Bonfils Intubation Fibrescope in success of intubation, time to&#xD;
      intubation and complication rate in patients with a fixed cervical collar.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success of intubation on first attempt</measure>
    <time_frame>up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation</time_frame>
    <description>A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time taken to successful intubation</measure>
    <time_frame>up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation</time_frame>
    <description>A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Time to successful intubation will then be measured from the first handling of the airway device, until successful intubation with an endotracheal tube is confirmed by the presence of end tidal carbon dioxide on a capnograph trace.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Intubation</condition>
  <condition>Airway</condition>
  <arm_group>
    <arm_group_label>Karl Storz C-MAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intubation of patient using the Karl Storz C-MAC video laryngoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bonfils Intubation Fibrescope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intubation of patient using Bonfils Intubation Fibrescope</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Karl Storz C-MAC</intervention_name>
    <arm_group_label>Karl Storz C-MAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bonfils Intubation Fibrescope</intervention_name>
    <arm_group_label>Bonfils Intubation Fibrescope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective surgery under general anaesthesia who require&#xD;
             endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of previous difficult endotracheal intubation&#xD;
&#xD;
          -  Patients with two or more predictors of difficult mask ventilation or difficult&#xD;
             intubation or the combination of both&#xD;
&#xD;
          -  Patients with ASA (American Society of Anesthesiologists) grading of III and above are&#xD;
             excluded from the study, as well as patients with 2 or more predictors for difficult&#xD;
             mask ventilation or difficult intubation or the combination of both.&#xD;
&#xD;
          -  Patients needing a rapid sequence induction for rapid securement of the airway&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients below the age of 21 years old&#xD;
&#xD;
          -  Patients unfit to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodore GL Wong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Theodore GL Wong</last_name>
    <phone>+6598203675</phone>
    <email>theodore.wong.g.l@sgh.com.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Theodore GL Wong</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hairil R Abdullah</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diana XH Chan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christine YK Yong</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Abdullah HR, Li-Ming T, Marriott A, Wong TG. A comparison between the Bonfils Intubation Fiberscope and McCoy laryngoscope for tracheal intubation in patients with a simulated difficult airway. Anesth Analg. 2013 Nov;117(5):1217-20. doi: 10.1213/ANE.0b013e3182a46fa9.</citation>
    <PMID>24029854</PMID>
  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02210338
org study id: sghan-cb01
nct id: NCT02210338
lead sponsor: 
has dmc: No
The study aims to determine the better device to facilitate intubation in patients with a
      limited neck movement and small mouth opening. This may help anesthesiology as well as
      emergency medicine practitioners and departments to decide when choosing between these two
      conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior
      when compared to the Bonfils Intubation Fibrescope in success of intubation, time to
      intubation and complication rate in patients with a fixed cervical collar.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Success of intubation on first attempt
time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation
description: A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.
measure: Time taken to successful intubation
time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation
description: A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Time to successful intubation will then be measured from the first handling of the airway device, until successful intubation with an endotracheal tube is confirmed by the presence of end tidal carbon dioxide on a capnograph trace.
arm group label: Karl Storz C-MAC
arm group type: Experimental
description: Intubation of patient using the Karl Storz C-MAC video laryngoscope
arm group label: Bonfils Intubation Fibrescope
arm group type: Experimental
description: Intubation of patient using Bonfils Intubation Fibrescope
intervention type: Device
intervention name: Karl Storz C-MAC
arm group label: Karl Storz C-MAC
intervention type: Device
intervention name: Bonfils Intubation Fibrescope
arm group label: Bonfils Intubation Fibrescope
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Theodore GL Wong
role: Principal Investigator
affiliation: Singapore General Hospital
last name: Theodore GL Wong
phone: +6598203675
email: theodore.wong.g.l@sgh.com.sg
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: Singapore
citation: Abdullah HR, Li-Ming T, Marriott A, Wong TG. A comparison between the Bonfils Intubation Fiberscope and McCoy laryngoscope for tracheal intubation in patients with a simulated difficult airway. Anesth Analg. 2013 Nov;117(5):1217-20. doi: 10.1213/ANE.0b013e3182a46fa9.
PMID: 24029854
responsible party type: Sponsor