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Epiglottic Downfolding During Endotracheal Intubation

This study has been withdrawn prior to enrollment.
(Main investigators (Pieters/van Zundert) changed institutions. Therefore, they were not able to start the study and decided to withdraw the study for now.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691963
First Posted: September 25, 2012
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Barbe Pieters, Catharina Ziekenhuis Eindhoven
  Purpose

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.


Condition Intervention
Intubation Complication Injury of Epiglottis Device: C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Epiglottic Downfolding During Endotracheal Intubation - An Alternative Technique to Improve Glottic Exposure and Facilitate Intubation?

Further study details as provided by Barbe Pieters, Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • The Cormack and Lehane grade [ Time Frame: Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes ]
    The Cormack and Lehane grade scored in both positions of the C-MAC® videolaryngoscope and consequent success of intubation


Secondary Outcome Measures:
  • Discomfort [ Time Frame: Patients will be followed for 24 hours postoperatively ]
    Sore throat, dysphonia, dysphagia and coughing reported by patients 2 and 24 hours postoperatively

  • Use of adjuncts [ Time Frame: Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes ]
    Frequency of use of a stylet, gum elastic bougie or BURP manoeuvre.


Enrollment: 0
Study Start Date: April 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group

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.

Experimental: Epiglottic downfolding

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.

Device: C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany)

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.

Other Name: Epiglottic downfolding during endotracheal intubation

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed patient consent
  • ASA I-III
  • Age > 18 years
  • Elective surgery, other than head and/or neck surgery
  • Elective surgery, duration < 1 hour in supine position
  • Pre-operative Mallampati I-II-III

Exclusion Criteria:

  • No informed patient consent
  • ASA IV
  • Age < 18 years
  • Preoperative complaints of sore throat, dysphagia, dysphonia and coughing
  • Emergency surgery, surgery of head and/of neck
  • Surgery during > 1 hour in other than supine position
  • Locoregional anaesthesia
  • Preoperative Mallampati IV
  • Known difficult airway
  • Bad dentition
  • Dental crowns and/or fixed partial denture
  • Risk of aspiration (fasted < 6 hours, gastroesophageal reflux)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691963


Locations
Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Barbe MA Pieters, MD Catharina Ziekenhuis Eindhoven
  More Information

Publications:
Responsible Party: Barbe Pieters, Principal investigator, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01691963     History of Changes
Other Study ID Numbers: M12-1233
NL40875.060.12 ( Other Identifier: Medisch Ethische Commissie Catharina Ziekenhuis Eindhoven )
First Submitted: September 19, 2012
First Posted: September 25, 2012
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Barbe Pieters, Catharina Ziekenhuis Eindhoven:
Epiglottis
Intubation
Laryngoscopy