Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation

Study Overview
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Brief Summary
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C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.

Detailed Description
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C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation.

Official Title
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Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation in Patients With Predicted Difficult Airway

Conditions
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Difficult Mask Ventilation, Difficult Intubation

Intervention / Treatment
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* Device: C-MAC VS
* Device: flexible fibreoptic bronchoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with BMI ≥ 30 kg/m2, presence of any predictors of difficult intubation; Mallampati score > =3; inter-incisor distance < 3 cm; thyromental distance < 6 cm; neck extension < 80°from neck flexion; cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation Exclusion Criteria: patients have increased risk of pulmonary aspiration; have significant medical diseases in term of cardiac, respiratory, hepatic, renal,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomly assigned into two equal groups using computer-generated randomization technique. The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS. The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VS group<br>include patients undergoing awake intubation using the C-MAC VS | Device: C-MAC VS<br>* The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS<br>|
| Placebo Comparator: FOB group<br>will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope. | Device: flexible fibreoptic bronchoscope<br>* The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time required for a wake intubation | assess the time required for a wake intubation using C-MAC VS versus FOB in patients with anticipated difficult airway. | 10 minutes |