Epiglottic Downfolding During Endotracheal Intubation

Intubation Complication Clinical Trial

Official title:

Epiglottic Downfolding During Endotracheal Intubation - An Alternative Technique to Improve Glottic Exposure and Facilitate Intubation?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01691963
• Other study ID #: M12-1233
• Secondary ID: NL40875.060.12
• Status: Withdrawn
• Phase: N/A
• First received: September 19, 2012
• Last updated: January 27, 2016
• Start date: April 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Injury of Epiglottis
• Intubation Complication

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View Citation

Merli G. Videolaryngoscopy: is it only a change of view? Minerva Anestesiol. 2010 Aug;76(8):569-71. Epub 2010 Apr 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Cormack and Lehane grade	The Cormack and Lehane grade scored in both positions of the C-MAC® videolaryngoscope and consequent success of intubation	Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes	No
Secondary	Discomfort	Sore throat, dysphonia, dysphagia and coughing reported by patients 2 and 24 hours postoperatively	Patients will be followed for 24 hours postoperatively	Yes
Secondary	Use of adjuncts	Frequency of use of a stylet, gum elastic bougie or BURP manoeuvre.	Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes	No