A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

Not Applicable

Completed

• Conditions: Supraglottic Airway
• Interventions: Device: Ambu AuraGain (size 1.5 or size 2.0); Device: LMA Supreme (size 1.5 or size 2.0)

• Registration Number: NCT02380768
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu AuraGain	Ambu AuraGain (size 1.5 or size 2.0)	Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
LMA Supreme	LMA Supreme (size 1.5 or size 2.0)	Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines

Primary Outcome Measures

Name	Time	Method
Oropharyngeal (airway) leak pressure - Initial	Assessed intraoperatively at the time of confirmed device placement	The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
Oropharyngeal (airway) leak pressure - 10 Minutes	Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device	The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway

Secondary Outcome Measures

Name	Time	Method
Time for Successful Placement of the Supraglottic Airway	Assessed intraoperatively at the time of confirmed device placement	Time for successful placement of supraglottic device will be recorded
Number of attempts to placement of Supraglottic Airway	Assessed intraoperatively at the time of confirmed device placement	Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)
Fiberoptic Grade of Laryngeal View through Supraglottic Airway	Assessed intraoperatively at the time of confirmed device placement	Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system
Gastric Tube Insertion Ease of Placement	Assessed intraoperatively at the time of confirmed gastric tube placement	The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.
Gastric Tube Insertion Time	Assessed intraoperatively at the time of confirmed gastric tube placement	The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
Gastric Tube Insertion Attempts	Assessed intraoperatively at the time of confirmed gastric tube placement	Number of insertion attempts of the gastric tube through the SGA will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
Postoperative Complications	Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.	Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.
Intraoperative Complications	Assessed intraoperatively	Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States