Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-12-31

Brief Summary

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We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).

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Detailed Description

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Conditions

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Difficult Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Intervention

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

Group Type EXPERIMENTAL

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)

Intervention Type DEVICE

The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Interventions

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aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)

The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Intervention Type DEVICE

Control

pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Intervention Type DEVICE

Other Intervention Names

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video-stylet

Eligibility Criteria

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Inclusion Criteria

* BMI \> 35
* Thyromental distance \< 6 cm
* Sterno-mental distance \< 12 cm
* Mallampati grade 3 and 4
* Interincisor distance \< 38 mm
* Status of dentition: presence of buckteeth
* Neck movement \< 35°
* Neck circumference \>43 cm at the level of the thyroid cartilage
* Patients with immobilized cervical spine (C-collar in place).
* History of difficult laryngoscopy or intubation