A Comparison of the C-mac and Bonfils Intubation Fibrescope

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02210338
• Other study ID #: sghan-cb01
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2014
• Last updated: April 27, 2016
• Start date: August 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Singapore General Hospital
• Contact: Theodore GL Wong
• Phone: +6598203675
• Email: theodore.wong.g.l[@]sgh.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway
• Intubation

Intervention

Device:
• Karl Storz C-MAC

• Bonfils Intubation Fibrescope

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes