A Comparison of the C-mac and Bonfils Intubation Fibrescope

A Comparison of the C-mac and Bonfils Intubation Fibrescope for Tracheal Intubation in Patients With a Simulated Difficult Airway

The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior when compared to the Bonfils Intubation Fibrescope in success of intubation, time to intubation and complication rate in patients with a fixed cervical collar.

Study Overview

• Status: Unknown
• Conditions: Intubation; Airway
• Intervention / Treatment: Device: Karl Storz C-MAC; Device: Bonfils Intubation Fibrescope

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Recruiting
    • Singapore General Hospital
    • Principal Investigator: Theodore GL Wong
    • Sub-Investigator: Hairil R Abdullah
    • Sub-Investigator: Diana XH Chan
    • Sub-Investigator: Christine YK Yong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing elective surgery under general anaesthesia who require endotracheal intubation

Exclusion Criteria:

• Patients with history of previous difficult endotracheal intubation
• Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
• Patients with ASA (American Society of Anesthesiologists) grading of III and above are excluded from the study, as well as patients with 2 or more predictors for difficult mask ventilation or difficult intubation or the combination of both.
• Patients needing a rapid sequence induction for rapid securement of the airway
• Pregnant women
• Patients below the age of 21 years old
• Patients unfit to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Karl Storz C-MAC; Intubation of patient using the Karl Storz C-MAC video laryngoscope	Device: Karl Storz C-MAC
Experimental: Bonfils Intubation Fibrescope; Intubation of patient using Bonfils Intubation Fibrescope	Device: Bonfils Intubation Fibrescope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of intubation on first attempt	A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.	up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken to successful intubation	A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Time to successful intubation will then be measured from the first handling of the airway device, until successful intubation with an endotracheal tube is confirmed by the presence of end tidal carbon dioxide on a capnograph trace.	up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Theodore GL Wong, Singapore General Hospital

Publications and helpful links

General Publications

• Abdullah HR, Li-Ming T, Marriott A, Wong TG. A comparison between the Bonfils Intubation Fiberscope and McCoy laryngoscope for tracheal intubation in patients with a simulated difficult airway. Anesth Analg. 2013 Nov;117(5):1217-20. doi: 10.1213/ANE.0b013e3182a46fa9.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: sghan-cb01