A Comparison of the C-mac and Bonfils Intubation Fibrescope

Study Overview
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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.

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

Conditions
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Intubation, Airway

Intervention / Treatment
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* Device: Karl Storz C-MAC
* Device: Bonfils Intubation Fibrescope


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Karl Storz C-MAC<br>Intubation of patient using the Karl Storz C-MAC video laryngoscope | Device: Karl Storz C-MAC<br> <br> |
| Experimental: Bonfils Intubation Fibrescope<br>Intubation of patient using Bonfils Intubation Fibrescope | Device: Bonfils Intubation Fibrescope<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |