Epiglottic Downfolding During Endotracheal Intubation

NCT ID: NCT01691963

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-01-31

Brief 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.

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.

Conditions

Intubation Complication; Injury of Epiglottis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Epiglottic downfolding during endotracheal intubation

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Barbe Pieters

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbe MA Pieters, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Ziekenhuis Eindhoven

Eindhoven, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 20357168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16905081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20661194 (View on PubMed)

Other Identifiers

NL40875.060.12

Identifier Type: OTHER

Identifier Source: secondary_id

M12-1233

Identifier Type: -

Identifier Source: org_study_id