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

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-06-01

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.

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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.

Conditions

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Difficult Mask Ventilation Difficult Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VS group

include patients undergoing awake intubation using the C-MAC VS

Group Type ACTIVE_COMPARATOR

C-MAC VS

Intervention Type DEVICE

The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS

FOB group

will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Group Type PLACEBO_COMPARATOR

flexible fibreoptic bronchoscope

Intervention Type DEVICE

The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Interventions

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C-MAC VS

The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS

Intervention Type DEVICE

flexible fibreoptic bronchoscope

The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.

Intervention Type DEVICE

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