Clinical trial NCT01691703: Combined Technique for Difficult Intubation
Official title: Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Failed or Difficult Intubation
Failed or Difficult Intubation, Initial Encounter
Anesthesia Intubation Complication
Keywords: Fiber Optic Technology/methods
Intubation, Intratracheal/methods
Laryngoscopy/methods
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: 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.
timeFrame: The patients will be followed during induction of anesthesia, an average of 10 minutes
Secondary outcomes:
measure: Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.
timeFrame: The patients will be followed during induction of anesthesia, an average of 10 minutes
measure: Time until successful endotracheal intubation
timeFrame: The patients will be followed during induction of anesthesia, an average of maximal 3 minutes
measure: Complications rendered on during the procedure
timeFrame: The patients will be followed during induction of anesthesia, an average of 10 minutes
measure: Adjuncts being used
timeFrame: The patients will be followed during induction of anesthesia, an average of 10 minutes
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Barbe MA Pieters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Zundert AA, Pieters BM. Combined technique using videolaryngoscopy and Bonfils for a difficult airway intubation. Br J Anaesth. 2012 Feb;108(2):327-8. doi: 10.1093/bja/aer471. No abstract available.