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A Comparison of the C-mac and Bonfils Intubation Fibrescope

Not Applicable
Conditions
Intubation
Airway
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

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
Primary Outcome Measures
NameTimeMethod
Success of intubation on first attemptup 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
NameTimeMethod
Time taken to successful intubationup 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

Singapore General Hospital
🇸🇬Singapore, Singapore
Theodore GL Wong
Principal Investigator
Hairil R Abdullah
Sub Investigator
Diana XH Chan
Sub Investigator
Christine YK Yong
Sub Investigator

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