A Comparison of the C-mac and Bonfils Intubation Fibrescope

Not Applicable

• Conditions: Intubation; Airway
• Interventions: Device: Bonfils Intubation Fibrescope; Device: Karl Storz C-MAC

• Registration Number: NCT02210338
• Lead Sponsor: Singapore General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bonfils Intubation Fibrescope	Bonfils Intubation Fibrescope	Intubation of patient using Bonfils Intubation Fibrescope
Karl Storz C-MAC	Karl Storz C-MAC	Intubation of patient using the Karl Storz C-MAC video laryngoscope

Primary Outcome Measures

Name	Time	Method
Success of intubation on first attempt	up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at 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. 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.

Secondary Outcome Measures

Name	Time	Method
Time taken to successful intubation	up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after 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.

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore