Videolaryngoscopes for Tracheal 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

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.

Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance \< 30 mm, mental-thyroidal distance \< 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged \< 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.

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Detailed Description

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Conditions

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Airway Management

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endotracheal intubation with Imago V-blade

Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes.

Group Type EXPERIMENTAL

Imago V-Balde

Intervention Type DEVICE

the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual

endotracheal intubation with Glidescope

Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes.

Group Type ACTIVE_COMPARATOR

Glidescope

Intervention Type DEVICE

the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

Interventions

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Imago V-Balde

the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual

Intervention Type DEVICE

Glidescope

the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years
* Mallampati class 3-4
* inter-incisor distance \< 30 mm
* mental-thyroidal distance \< 60 mm
* large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
* reduced mental-jugular distance.