A Comparison of the C-mac and Bonfils Intubation Fibrescope

NCT ID: NCT02210338

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Intubation Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Karl Storz C-MAC

Intubation of patient using the Karl Storz C-MAC video laryngoscope

Group Type EXPERIMENTAL

Karl Storz C-MAC

Intervention Type DEVICE

Bonfils Intubation Fibrescope

Intubation of patient using Bonfils Intubation Fibrescope

Group Type EXPERIMENTAL

Bonfils Intubation Fibrescope

Intervention Type DEVICE

Interventions

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Karl Storz C-MAC

Intervention Type DEVICE

Bonfils Intubation Fibrescope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theodore GL Wong

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Theodore GL Wong

Role: CONTACT

+6598203675

References

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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.

Reference Type BACKGROUND
PMID: 24029854 (View on PubMed)

Other Identifiers

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sghan-cb01

Identifier Type: -

Identifier Source: org_study_id

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