King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.

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Detailed Description

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The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.

Conditions

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Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Ambu King Vision Video Laryngoscope aBlade System

The trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement.

Group Type EXPERIMENTAL

Ambu King Vision Video Laryngoscope aBlade

Intervention Type DEVICE

At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.

Direct Laryngoscope

The trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement.

Group Type ACTIVE_COMPARATOR

Direct Laryngoscopy via Miller Straight Blade

Intervention Type DEVICE

At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.

Interventions

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Ambu King Vision Video Laryngoscope aBlade

At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.

Intervention Type DEVICE

Direct Laryngoscopy via Miller Straight Blade

At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.

Intervention Type DEVICE

Other Intervention Names

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King Vision Video Laryngoscope Miller Blade, Wisconsin blade, Straight blade

Eligibility Criteria

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Inclusion Criteria

* ASA (American Society of Anesthesiologists) I-III classified patients
* Patients undergoing procedure where an endotracheal tube would be normally utilized