A Comparison of the C-mac and Bonfils Intubation Fibrescope

Singapore General Hospital64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intubation Airway

Interventions

Karl Storz C-MACDEVICE

Bonfils Intubation FibrescopeDEVICE

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Singapore General Hospital

Singapore, Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation

Secondary Outcomes

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.

Time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation

Central Contacts

Theodore GL Wong

CONTACT

+6598203675 theodore.wong.g.l@sgh.com.sg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.