Combined Technique for Difficult Intubation

Anesthesia Intubation Complication Clinical Trial

Official title:

Combined Technique Using Videolaryngoscopy and Bonfils for a Difficult Airway Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691703
• Other study ID #: COM.12
• Secondary ID: 12-624
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: February 19, 2013
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Proportion of successful intubation with the 2 methods under study, without the use of adjuncts.	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	Yes
Secondary	Time until successful endotracheal intubation	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.	The patients will be followed during induction of anesthesia, an average of maximal 3 minutes	No
Secondary	Complications rendered on during the procedure	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.	The patients will be followed during induction of anesthesia, an average of 10 minutes	Yes
Secondary	Adjuncts being used	Adjuncts that can be used are: gum elastic bougie, stylet and the BURP manoeuvre (performed by a second operator).	The patients will be followed during induction of anesthesia, an average of 10 minutes	No