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Clinical Trials/NCT01691703
NCT01691703
Completed
Not Applicable

Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation

Catharina Ziekenhuis Eindhoven1 site in 1 country40 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation; Difficult
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
40
Locations
1
Primary Endpoint
Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

A difficult tracheal intubation can be a problem, even if one has taken all precautions. A possible solution can be using a videolaryngoscope in conjunct with the Bonfils® intubation scope. As such, the videolaryngoscope can be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® intubation scope.

Detailed Description

In this blinded, unrandomised trial the investigators would like to investigate the change in Cormack and Lehane grade when using both videolaryngoscope (Macintosh videolaryngoscope, Karl Storz, Tuttlingen, Germany) and Bonfils® (Karl Storz, Tuttlingen, Germany). They also want to record the success of intubation and the time needed until successful endotracheal intubation when using this technique as well as complications (trauma to the oral cavity, dental trauma, and regurgitation seen by the anaesthesiologist) that may occur. Also saturation (SpO2) at the end of the procedure will be noted and adjuncts that are used.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
February 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Barbe Pieters

MD

Catharina Ziekenhuis Eindhoven

Eligibility Criteria

Inclusion Criteria

  • Informed patient consent Age \> 18 years History of difficult intubation (Cormack and Lehane III-IV)
  • One or more predictors of a difficult intubation:
  • restricted neck movement
  • thyromental distance \< 60 mm
  • interincisor/interdental distance \< 30mm
  • BMI \> 35 kg.m-2 Elective surgery making endotracheal intubation necessary (other than head and/or neck surgery) Fasted (≥ 6 hours)

Exclusion Criteria

  • No informed patient consent Age \< 18 years Emergency surgery, head and/or neck surgery Fasted \< 6 hours

Outcomes

Primary Outcomes

Cormack and Lehane grade achieved when using the combination technique compared with the Cormack and Lehane grade achieved earlier when using the Macintosh (video)laryngoscope alone.

Time Frame: The patients will be followed during induction of anesthesia, an average of 10 minutes

The operator will score these grades during the process of intubation. Pictures will be taken of the first and the second Cormack and Lehane grade, and these pictures will later be scored by two anaesthesiologists, blinded for the technique used (videolaryngoscopy alone or videolaryngoscopy combined with the Bonfils®).

Secondary Outcomes

  • Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.(The patients will be followed during induction of anesthesia, an average of 10 minutes)
  • Time until successful endotracheal intubation(The patients will be followed during induction of anesthesia, an average of maximal 3 minutes)
  • Complications rendered on during the procedure(The patients will be followed during induction of anesthesia, an average of 10 minutes)
  • Adjuncts being used(The patients will be followed during induction of anesthesia, an average of 10 minutes)

Study Sites (1)

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