Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation

NCT ID: NCT04759300

Last Updated: 2022-06-01

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-07-31

Brief Summary

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Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.

Detailed Description

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The 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. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.

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. Group C-MAC VS (VS group) included patients undergoing tracheal intubation using the C-MAC VS. Group C-MAC VL D -blade (D group) included patients undergoing intubation using the C-MAC VL D-blade.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group C-MAC VS

patients undergoing tracheal intubation using the C-MAC VS.

Group Type ACTIVE_COMPARATOR

C-MAC VS

Intervention Type DEVICE

patients undergoing tracheal intubation using the C-MAC VS

Group C-MAC VL D -blade

patients undergoing intubation using the C-MAC VL D-blade.

Group Type PLACEBO_COMPARATOR

C-MAC VL D -blade

Intervention Type DEVICE

patients undergoing intubation using the C-MAC VL D-blade.

Interventions

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C-MAC VS

patients undergoing tracheal intubation using the C-MAC VS

Intervention Type DEVICE

C-MAC VL D -blade

patients undergoing intubation using the C-MAC VL D-blade.

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

Exclusion Criteria

* patients have increased risk of pulmonary aspiration;
* have significant medical diseases in term of cardiac, respiratory, hepatic, renal
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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rehab zayed

Assisstant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rehab A. Abd Elaziz, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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rehab Abd Elaziz

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0304844

Identifier Type: -

Identifier Source: org_study_id

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