Epiglottic Downfolding During Endotracheal Intubation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Catharina Ziekenhuis Eindhoven
Sponsor:
Information provided by (Responsible Party):
Barbe Pieters, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01691963
First received: September 19, 2012
Last updated: April 3, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Frequency of use of a stylet, gum elastic bougie or BURP manoeuvre.


Estimated Enrollment: 140
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691963

Contacts
Contact: Barbe MA Pieters, MD +31642800477 bmapieters@gmail.com
Contact: Andre AJ van Zundert, MD PhD FRCA +3140 239 91 11 zundert@iae.nl

Locations
Netherlands
Catharina Ziekenhuis Eindhoven Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Barbe MA Pieters, MD    +31642800477    bmapieters@gmail.com   
Contact: Andre AJ van Zundert, MD FRCA PhD       zundert@iae.nl   
Principal Investigator: Barbe MA Pieters, MD         
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
Study First Received: September 19, 2012
Last Updated: April 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Epiglottis
Intubation
Laryngoscopy

ClinicalTrials.gov processed this record on September 16, 2014