A Comparison of the Ambu AuraGain Versus LMA Supreme 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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.

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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 airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.

Conditions

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Supraglottic Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Ambu AuraGain

Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines

Group Type EXPERIMENTAL

Ambu AuraGain (size 1.5 or size 2.0)

Intervention Type DEVICE

The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.

LMA Supreme

Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines

Group Type ACTIVE_COMPARATOR

LMA Supreme (size 1.5 or size 2.0)

Intervention Type DEVICE

The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.

Interventions

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Ambu AuraGain (size 1.5 or size 2.0)

The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.

Intervention Type DEVICE

LMA Supreme (size 1.5 or size 2.0)

The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.

Intervention Type DEVICE

Other Intervention Names

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Ambu AuraGain LMA Supreme

Eligibility Criteria

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Inclusion Criteria

* Scheduled for surgery utilizing a supraglottic airway device
* ASA (American Society of Anesthesiologists) I-III classification
* Weighing between 5 - 20 kilograms

Exclusion Criteria

* Active respiratory infection
* History of difficult mask ventilation
* Diagnosis of congenital syndrome with difficult airway management
* Active gastrointestinal reflux
* Coagulopathy
* Significant Pulmonary disease
* Emergent surgery

Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes