Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02210338
Enrollment
64
Registered
2014-08-06
Start date
2014-08-31
Completion date
2017-03-31
Last updated
2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway, Intubation

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.

Interventions

DEVICEKarl Storz C-MAC
DEVICEBonfils Intubation Fibrescope

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 intubationA 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

MeasureTime frameDescription
Time taken to successful intubationup to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubationA 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.

Countries

Singapore

Contacts

Primary ContactTheodore GL Wong
theodore.wong.g.l@sgh.com.sg+6598203675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026