<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/NCT01691703</url>
  </required_header>
  <id_info>
    <org_study_id>COM.12</org_study_id>
    <secondary_id>12-624</secondary_id>
    <nct_id>NCT01691703</nct_id>
  </id_info>
  <brief_title>Combined Technique for Difficult Intubation</brief_title>
  <official_title>Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A difficult tracheal intubation can be a problem, even if one has taken all precautions. A&#xD;
      possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation&#xD;
      scope. As such, the videolaryngoscope can be used to achieve the best possible view and space&#xD;
      of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this blinded, unrandomised trial the investigators would like to investigate the change in&#xD;
      Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl&#xD;
      Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to&#xD;
      record the success of intubation and the time needed until successful endotracheal intubation&#xD;
      when using this technique as well as complications (trauma to the oral cavity, dental trauma,&#xD;
      and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at&#xD;
      the end of the procedure will be noted and adjuncts that are used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.</measure>
    <time_frame>The patients will be followed during induction of anesthesia, an average of 10 minutes</time_frame>
    <description>The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.</measure>
    <time_frame>The patients will be followed during induction of anesthesia, an average of 10 minutes</time_frame>
    <description>Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time until successful endotracheal intubation</measure>
    <time_frame>The patients will be followed during induction of anesthesia, an average of maximal 3 minutes</time_frame>
    <description>Time until successful endotracheal intubation will be defined as the time from the moment the blade of the Macintosh videolaryngoscope is placed between the teeth until the time the anaesthesiologist confirms the endotracheal tube to be in the trachea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications rendered on during the procedure</measure>
    <time_frame>The patients will be followed during induction of anesthesia, an average of 10 minutes</time_frame>
    <description>Complications that will be recorded are: trauma to the oral cavity (defined as any amount of bright red blood in the oral cavity), dental trauma, and regurgitation seen by the anaesthesiologist. Also oxygen saturation (SpO2) at the end of the procedure will be noted, a saturation of less than 90% will be defined as hypoxia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjuncts being used</measure>
    <time_frame>The patients will be followed during induction of anesthesia, an average of 10 minutes</time_frame>
    <description>Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Intubation; Difficult</condition>
  <condition>Failed or Difficult Intubation</condition>
  <condition>Failed or Difficult Intubation, Initial Encounter</condition>
  <condition>Anesthesia Intubation Complication</condition>
  <arm_group>
    <arm_group_label>Videolaryngoscope and Bonfils</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Videolaryngoscope and Bonfils</intervention_name>
    <description>First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.</description>
    <arm_group_label>Videolaryngoscope and Bonfils</arm_group_label>
    <other_name>Macintosh videolaryngoscope (Karl Storz)</other_name>
    <other_name>Bonfils® (Karl Storz)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed patient consent Age &gt; 18 years History of difficult intubation (Cormack and&#xD;
             Lehane III-IV)&#xD;
&#xD;
        One or more predictors of a difficult intubation:&#xD;
&#xD;
          -  restricted neck movement&#xD;
&#xD;
          -  thyromental distance &lt; 60 mm&#xD;
&#xD;
          -  interincisor/interdental distance &lt; 30mm&#xD;
&#xD;
          -  BMI &gt; 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than&#xD;
             head and/or neck surgery) Fasted (≥ 6 hours)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed patient consent Age &lt; 18 years Emergency surgery, head and/or neck surgery&#xD;
             Fasted &lt; 6 hours&#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>Barbe MA Pieters, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catharina Ziekenhuis Eindhoven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catharina Ziekenhuis Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Van Zundert AA, Pieters BM. Combined technique using videolaryngoscopy and Bonfils for a difficult airway intubation. Br J Anaesth. 2012 Feb;108(2):327-8. doi: 10.1093/bja/aer471. No abstract available.</citation>
    <PMID>22250284</PMID>
  </reference>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 19, 2013</last_update_submitted>
  <last_update_submitted_qc>February 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>Barbe Pieters</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Fiber Optic Technology/methods</keyword>
  <keyword>Intubation, Intratracheal/methods</keyword>
  <keyword>Laryngoscopy/methods</keyword>
  <!-- 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/NCT01691703
org study id: COM.12
secondary id: 12-624
nct id: NCT01691703
lead sponsor: 
has dmc: No
A difficult tracheal intubation can be a problem, even if one has taken all precautions. A
      possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation
      scope. As such, the videolaryngoscope can be used to achieve the best possible view and space
      of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.
In this blinded, unrandomised trial the investigators would like to investigate the change in
      Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl
      Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to
      record the success of intubation and the time needed until successful endotracheal intubation
      when using this technique as well as complications (trauma to the oral cavity, dental trauma,
      and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at
      the end of the procedure will be noted and adjuncts that are used.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Outcomes Assessor)
measure: Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.
time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
description: The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).
measure: Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.
time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
description: Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.
measure: Time until successful endotracheal intubation
time frame: The patients will be followed during induction of anesthesia, an average of maximal 3 minutes
description: Time until successful endotracheal intubation will be defined as the time from the moment the blade of the Macintosh videolaryngoscope is placed between the teeth until the time the anaesthesiologist confirms the endotracheal tube to be in the trachea.
measure: Complications rendered on during the procedure
time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
description: Complications that will be recorded are: trauma to the oral cavity (defined as any amount of bright red blood in the oral cavity), dental trauma, and regurgitation seen by the anaesthesiologist. Also oxygen saturation (SpO2) at the end of the procedure will be noted, a saturation of less than 90% will be defined as hypoxia.
measure: Adjuncts being used
time frame: The patients will be followed during induction of anesthesia, an average of 10 minutes
description: Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).
arm group label: Videolaryngoscope and Bonfils
arm group type: Experimental
description: First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.
intervention type: Device
intervention name: Videolaryngoscope and Bonfils
description: First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.
arm group label: Videolaryngoscope and Bonfils
other name: Macintosh videolaryngoscope (Karl Storz)
other name: Bonfils® (Karl Storz)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbe MA Pieters, MD
role: Principal Investigator
affiliation: Catharina Ziekenhuis Eindhoven
facility: 
country: Netherlands
citation: Van Zundert AA, Pieters BM. Combined technique using videolaryngoscopy and Bonfils for a difficult airway intubation. Br J Anaesth. 2012 Feb;108(2):327-8. doi: 10.1093/bja/aer471. No abstract available.
PMID: 22250284
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Barbe Pieters
investigator title: MD