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Completed

NCT Number: NCT01691703

Combined Technique for Difficult Intubation

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.

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Key information

Conditions

Intubation; Difficult Anesthesia Intubation Complication Failed or Difficult Intubation Failed or Difficult Intubation, Initial Encounter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Ziekenhuis Eindhoven

Eindhoven, 5623 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Macintosh videolaryngoscope (Karl Storz), Bonfils® (Karl Storz)

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.

    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

  1. Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.

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

    Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.

  2. Time until successful endotracheal intubation

    Time frame: The patients will be followed during induction of anesthesia, an average of maximal 3 minutes

    Time until successful endotracheal intubation will be defined as the time from the moment the blade of the Macintosh videolaryngoscope is placed between the teeth until the time the anaesthesiologist confirms the endotracheal tube to be in the trachea.

  3. Complications rendered on during the procedure

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

    Complications that will be recorded are: trauma to the oral cavity (defined as any amount of bright red blood in the oral cavity), dental trauma, and regurgitation seen by the anaesthesiologist. Also oxygen saturation (SpO2) at the end of the procedure will be noted, a saturation of less than 90% will be defined as hypoxia.

  4. Adjuncts being used

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

    Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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