Combined Technique for Difficult Intubation

NCT01691703 | Completed

• 2 other identifiers: COM.1212-624
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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®).

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

Secondary Outcomes (4)

• 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 Arms (1)

Videolaryngoscope and Bonfils

EXPERIMENTAL

First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.

Device: Videolaryngoscope and Bonfils

Interventions

Videolaryngoscope and Bonfils DEVICE

First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.

Also known as: Macintosh videolaryngoscope (Karl Storz), Bonfils® (Karl Storz)

Videolaryngoscope and Bonfils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, 5623 EJ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 22250284 BACKGROUND

Study Officials

• Barbe MA Pieters, MD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 25, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

NL (1)