Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small 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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-07-31

Brief Summary

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The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?

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Detailed Description

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The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal intubation, and peri-operative complications will also be assessed.

Conditions

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Fiberoptic Intubation in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Fiberoptic Intubation performed by an expert

Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q

Group Type ACTIVE_COMPARATOR

air-Q, followed by fiberoptic intubation

Intervention Type DEVICE

Free-hand Fiberoptic Intubation

Intervention Type DEVICE

Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed

Fiberoptic Intubation performed by a novice

Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q

Group Type EXPERIMENTAL

air-Q, followed by fiberoptic intubation

Intervention Type DEVICE

Free-hand Fiberoptic Intubation

Intervention Type DEVICE

Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed

Interventions

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air-Q, followed by fiberoptic intubation

Intervention Type DEVICE

Free-hand Fiberoptic Intubation

Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed

Intervention Type DEVICE

Other Intervention Names

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Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Eligibility Criteria

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Inclusion Criteria

* Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
* Age 1 month - 2 years
* Weight 1-20 Kg

Exclusion Criteria

* Children with active respiratory infection
* Known history of difficult mask ventilation
* Diagnosis of a congenital syndrome associated with difficult airway management
* Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).

Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes