Combined Technique for Difficult Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbe Pieters, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01691703
First received: September 18, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Intubation; Difficult
Failed or Difficult Intubation
Failed or Difficult Intubation, Initial Encounter
Anesthesia Intubation Complication
Device: Videolaryngoscope and Bonfils

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation

Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.

  • Time until successful endotracheal intubation [ Time Frame: The patients will be followed during induction of anesthesia, an average of maximal 3 minutes ] [ Designated as safety issue: No ]
    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.

  • Complications rendered on during the procedure [ Time Frame: The patients will be followed during induction of anesthesia, an average of 10 minutes ] [ Designated as safety issue: Yes ]
    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.

  • Adjuncts being used [ Time Frame: The patients will be followed during induction of anesthesia, an average of 10 minutes ] [ Designated as safety issue: No ]
    Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).


Enrollment: 40
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Videolaryngoscope and Bonfils
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
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691703

Locations
Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Barbe MA Pieters, MD Catharina Ziekenhuis Eindhoven
  More Information

Publications:
Responsible Party: Barbe Pieters, MD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01691703     History of Changes
Other Study ID Numbers: COM.12, 12-624
Study First Received: September 18, 2012
Last Updated: February 19, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Fiber Optic Technology/methods
Intubation, Intratracheal/methods
Laryngoscopy/methods

ClinicalTrials.gov processed this record on October 20, 2014