A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

Ann & Robert H Lurie Children's Hospital of Chicago100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

100

Conditions

Supraglottic Airway

Interventions

Ambu AuraGain (size 1.5 or size 2.0)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 (size 1.5 or size 2.0)DEVICE

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Oropharyngeal (airway) leak pressure - Initial

The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway

Time frame: Assessed intraoperatively at the time of confirmed device placement

Oropharyngeal (airway) leak pressure - 10 Minutes

The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway

Time frame: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device

Secondary Outcomes

Time for Successful Placement of the Supraglottic Airway

Time for successful placement of supraglottic device will be recorded

Time frame: Assessed intraoperatively at the time of confirmed device placement

Number of attempts to placement of Supraglottic Airway

Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)

Time frame: Assessed intraoperatively at the time of confirmed device placement

Fiberoptic Grade of Laryngeal View through Supraglottic Airway

Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system

Time frame: Assessed intraoperatively at the time of confirmed device placement

Gastric Tube Insertion Ease of Placement

The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.

Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement

Data from ClinicalTrials.gov

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