<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/NCT01691963</url>
  </required_header>
  <id_info>
    <org_study_id>M12-1233</org_study_id>
    <secondary_id>NL40875.060.12</secondary_id>
    <nct_id>NCT01691963</nct_id>
  </id_info>
  <brief_title>Epiglottic Downfolding During Endotracheal Intubation</brief_title>
  <official_title>Epiglottic Downfolding During Endotracheal Intubation - An Alternative Technique to Improve Glottic Exposure and Facilitate 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Usually videolaryngoscopy using a videolaryngoscope with a classic Macintosh design is&#xD;
      performed with the blade in the vallecula and the epiglottis elevated from the vocal cords&#xD;
      indirectly, as in direct laryngoscopy. However, during an audit of videolaryngoscopic&#xD;
      practice we noticed that, in obtaining the best view, clinicians frequently and inadvertently&#xD;
      advanced the blade into the vallecula to get a better view, such that the epiglottis was&#xD;
      downfolded and elevated directly from the vocal cords. However, a better view does not&#xD;
      necessarily lead to higher intubation success.&#xD;
&#xD;
      In this randomized, controlled trial, we want to determine the efficacy of&#xD;
      videolaryngoscope-guided tracheal intubation using an alternative position for the blade in&#xD;
      patients with normal airways.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anaesthesia will be induced in the conventional matter. For patients randomized to the&#xD;
      intervention group, when the anaesthesiologist considers the depth of anaesthesia to be&#xD;
      sufficient, a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany), will be placed into&#xD;
      the patients mouth. The best possible view of the vocal cords will be obtained with the blade&#xD;
      positioned normally in the vallecula anterior to the epiglottis. The epiglottis will be&#xD;
      elevated from the vocal cords indirectly, identical with direct laryngoscopy. After this, the&#xD;
      best possible view of the vocal cords will be obtained with the blade positioned&#xD;
      alternatively in the vallecula posterior to the epiglottis, such that the epiglottis is&#xD;
      downfolded and elevated directly from the vocal cords. Views will be scored in both positions&#xD;
      using the Cormack and Lehane classification system. When correct laryngoscope positioning&#xD;
      can't be achieved with a size 3 blade, a size 4 blade will be used.&#xD;
&#xD;
      For patients not randomized to the intervention group, anaesthesia will also be induced in&#xD;
      the conventional matter. When the anaesthesiologist considers the depth of anaesthesia to be&#xD;
      sufficient, a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany), will be placed into&#xD;
      the patients mouth. The best possible view of the vocal cords will be obtained with the blade&#xD;
      positioned normally in the vallecula anterior to the epiglottis. The epiglottis will be&#xD;
      elevated from the vocal cords indirectly, identical with direct laryngoscopy. The view will&#xD;
      be scored in this position using the Cormack and Lehane classification system. After this,&#xD;
      the patient will be intubated.&#xD;
&#xD;
      Patients will be interviewed 2 and 24 hours postoperatively about sore throat, dysphonia,&#xD;
      dysphagia and coughing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Main investigators (Pieters/van Zundert) changed institutions. Therefore, they were not able to&#xD;
    start the study and decided to withdraw the study for now.&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Cormack and Lehane grade</measure>
    <time_frame>Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes</time_frame>
    <description>The Cormack and Lehane grade scored in both positions of the C-MAC® videolaryngoscope and consequent success of intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discomfort</measure>
    <time_frame>Patients will be followed for 24 hours postoperatively</time_frame>
    <description>Sore throat, dysphonia, dysphagia and coughing reported by patients 2 and 24 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of adjuncts</measure>
    <time_frame>Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes</time_frame>
    <description>Frequency of use of a stylet, gum elastic bougie or BURP manoeuvre.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Intubation Complication</condition>
  <condition>Injury of Epiglottis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group, anaesthesia will be induced in the same way as mentioned above for the intervention group. Also in this group, intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.&#xD;
The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula. The glottic view will be scored in this position using the Cormack and Lehane classification system. If correct laryngoscope positioning cannot be achieved with a size 3 blade, a size 4 blade will be used. Hereafter, the patient's trachea will be intubated once the optimal view of the larynx had been obtained. Intubation attempts will be scored in the same way as mentioned above for the intervention group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epiglottic downfolding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endotracheal intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.&#xD;
The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula.&#xD;
Next, the view of the glottic inlet will be scored with the blade advanced further into the vallecula, until the epiglottis flips infero-posteriorly and becomes downfolded into the trachea.&#xD;
The glottic view will be scored in both positions using the Cormack and Lehane classification system.&#xD;
After successful intubation, the blade will slowly be withdrawn into the vallecula to elevate the epiglottis back to its normal position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany)</intervention_name>
    <description>Endotracheal intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.&#xD;
The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula.&#xD;
Next, the view of the glottic inlet will be scored with the blade advanced further into the vallecula, until the epiglottis flips infero-posteriorly and becomes downfolded into the trachea.&#xD;
The glottic view will be scored in both positions using the Cormack and Lehane classification system.&#xD;
After successful intubation, the blade will slowly be withdrawn into the vallecula to elevate the epiglottis back to its normal position.</description>
    <arm_group_label>Epiglottic downfolding</arm_group_label>
    <other_name>Epiglottic downfolding during endotracheal intubation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed patient consent&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Elective surgery, other than head and/or neck surgery&#xD;
&#xD;
          -  Elective surgery, duration &lt; 1 hour in supine position&#xD;
&#xD;
          -  Pre-operative Mallampati I-II-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed patient consent&#xD;
&#xD;
          -  ASA IV&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Preoperative complaints of sore throat, dysphagia, dysphonia and coughing&#xD;
&#xD;
          -  Emergency surgery, surgery of head and/of neck&#xD;
&#xD;
          -  Surgery during &gt; 1 hour in other than supine position&#xD;
&#xD;
          -  Locoregional anaesthesia&#xD;
&#xD;
          -  Preoperative Mallampati IV&#xD;
&#xD;
          -  Known difficult airway&#xD;
&#xD;
          -  Bad dentition&#xD;
&#xD;
          -  Dental crowns and/or fixed partial denture&#xD;
&#xD;
          -  Risk of aspiration (fasted &lt; 6 hours, gastroesophageal reflux)&#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 A, van Zundert T, Brimacombe J. Downfolding of the epiglottis during intubation. Anesth Analg. 2010 Apr 1;110(4):1246-7. doi: 10.1213/ANE.0b013e3181ce716f. No abstract available.</citation>
    <PMID>20357168</PMID>
  </reference>
  <reference>
    <citation>Kaplan MB, Hagberg CA, Ward DS, Brambrink A, Chhibber AK, Heidegger T, Lozada L, Ovassapian A, Parsons D, Ramsay J, Wilhelm W, Zwissler B, Gerig HJ, Hofstetter C, Karan S, Kreisler N, Pousman RM, Thierbach A, Wrobel M, Berci G. Comparison of direct and video-assisted views of the larynx during routine intubation. J Clin Anesth. 2006 Aug;18(5):357-62. doi: 10.1016/j.jclinane.2006.01.002.</citation>
    <PMID>16905081</PMID>
  </reference>
  <reference>
    <citation>Merli G. Videolaryngoscopy: is it only a change of view? Minerva Anestesiol. 2010 Aug;76(8):569-71. Epub 2010 Apr 23. No abstract available.</citation>
    <PMID>20661194</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</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>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Epiglottis</keyword>
  <keyword>Intubation</keyword>
  <keyword>Laryngoscopy</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/NCT01691963
org study id: M12-1233
secondary id: NL40875.060.12
nct id: NCT01691963
lead sponsor: 
has dmc: Yes
Usually videolaryngoscopy using a videolaryngoscope with a classic Macintosh design is
      performed with the blade in the vallecula and the epiglottis elevated from the vocal cords
      indirectly, as in direct laryngoscopy. However, during an audit of videolaryngoscopic
      practice we noticed that, in obtaining the best view, clinicians frequently and inadvertently
      advanced the blade into the vallecula to get a better view, such that the epiglottis was
      downfolded and elevated directly from the vocal cords. However, a better view does not
      necessarily lead to higher intubation success.

      In this randomized, controlled trial, we want to determine the efficacy of
      videolaryngoscope-guided tracheal intubation using an alternative position for the blade in
      patients with normal airways.
Anaesthesia will be induced in the conventional matter. For patients randomized to the
      intervention group, when the anaesthesiologist considers the depth of anaesthesia to be
      sufficient, a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany), will be placed into
      the patients mouth. The best possible view of the vocal cords will be obtained with the blade
      positioned normally in the vallecula anterior to the epiglottis. The epiglottis will be
      elevated from the vocal cords indirectly, identical with direct laryngoscopy. After this, the
      best possible view of the vocal cords will be obtained with the blade positioned
      alternatively in the vallecula posterior to the epiglottis, such that the epiglottis is
      downfolded and elevated directly from the vocal cords. Views will be scored in both positions
      using the Cormack and Lehane classification system. When correct laryngoscope positioning
      can't be achieved with a size 3 blade, a size 4 blade will be used.

      For patients not randomized to the intervention group, anaesthesia will also be induced in
      the conventional matter. When the anaesthesiologist considers the depth of anaesthesia to be
      sufficient, a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany), will be placed into
      the patients mouth. The best possible view of the vocal cords will be obtained with the blade
      positioned normally in the vallecula anterior to the epiglottis. The epiglottis will be
      elevated from the vocal cords indirectly, identical with direct laryngoscopy. The view will
      be scored in this position using the Cormack and Lehane classification system. After this,
      the patient will be intubated.

      Patients will be interviewed 2 and 24 hours postoperatively about sore throat, dysphonia,
      dysphagia and coughing.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: The Cormack and Lehane grade
time frame: Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes
description: The Cormack and Lehane grade scored in both positions of the C-MAC® videolaryngoscope and consequent success of intubation
measure: Discomfort
time frame: Patients will be followed for 24 hours postoperatively
description: Sore throat, dysphonia, dysphagia and coughing reported by patients 2 and 24 hours postoperatively
measure: Use of adjuncts
time frame: Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes
description: Frequency of use of a stylet, gum elastic bougie or BURP manoeuvre.
arm group label: Control group
arm group type: No Intervention
description: In the control group, anaesthesia will be induced in the same way as mentioned above for the intervention group. Also in this group, intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.
The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula. The glottic view will be scored in this position using the Cormack and Lehane classification system. If correct laryngoscope positioning cannot be achieved with a size 3 blade, a size 4 blade will be used. Hereafter, the patient's trachea will be intubated once the optimal view of the larynx had been obtained. Intubation attempts will be scored in the same way as mentioned above for the intervention group.
arm group label: Epiglottic downfolding
arm group type: Experimental
description: Endotracheal intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.
The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula.
Next, the view of the glottic inlet will be scored with the blade advanced further into the vallecula, until the epiglottis flips infero-posteriorly and becomes downfolded into the trachea.
The glottic view will be scored in both positions using the Cormack and Lehane classification system.
After successful intubation, the blade will slowly be withdrawn into the vallecula to elevate the epiglottis back to its normal position.
intervention type: Device
intervention name: C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
description: Endotracheal intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.
The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula.
Next, the view of the glottic inlet will be scored with the blade advanced further into the vallecula, until the epiglottis flips infero-posteriorly and becomes downfolded into the trachea.
The glottic view will be scored in both positions using the Cormack and Lehane classification system.
After successful intubation, the blade will slowly be withdrawn into the vallecula to elevate the epiglottis back to its normal position.
arm group label: Epiglottic downfolding
other name: Epiglottic downfolding during endotracheal intubation
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 A, van Zundert T, Brimacombe J. Downfolding of the epiglottis during intubation. Anesth Analg. 2010 Apr 1;110(4):1246-7. doi: 10.1213/ANE.0b013e3181ce716f. No abstract available.
PMID: 20357168
citation: Kaplan MB, Hagberg CA, Ward DS, Brambrink A, Chhibber AK, Heidegger T, Lozada L, Ovassapian A, Parsons D, Ramsay J, Wilhelm W, Zwissler B, Gerig HJ, Hofstetter C, Karan S, Kreisler N, Pousman RM, Thierbach A, Wrobel M, Berci G. Comparison of direct and video-assisted views of the larynx during routine intubation. J Clin Anesth. 2006 Aug;18(5):357-62. doi: 10.1016/j.jclinane.2006.01.002.
PMID: 16905081
citation: Merli G. Videolaryngoscopy: is it only a change of view? Minerva Anestesiol. 2010 Aug;76(8):569-71. Epub 2010 Apr 23. No abstract available.
PMID: 20661194
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Barbe Pieters
investigator title: Principal investigator