NCT01691963

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

September 19, 2012

Last Update Submit

January 27, 2016

Conditions

Intubation ComplicationInjury of Epiglottis

Keywords

EpiglottisIntubationLaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Discomfort

    Patients will be followed for 24 hours postoperatively

  • Use of adjuncts

    Patients will be followed for the duration of induction of anaesthesia, an average of 10 minutes

Study Arms (2)

Control group

NO INTERVENTION

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.

Epiglottic downfolding

EXPERIMENTAL

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)

Interventions

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

Also known as: Epiglottic downfolding during endotracheal intubation
Epiglottic downfolding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, 5623 EJ, Netherlands

Location

Related Publications (3)

  • 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: 20357168BACKGROUND

  • 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: 16905081BACKGROUND

  • 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: 20661194BACKGROUND

Study Officials

  • Barbe MA Pieters, MD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 25, 2012

Study Start

April 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

NL(1)