A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Supraglottic Airway

Treatments: Device: Ambu AuraGain (size 1.5 or size 2.0); Device: LMA Supreme (size 1.5 or size 2.0)

Study type: Interventional

Funder types: Other

Identifiers

NCT02380768

IRB 2015-252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 3 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Ambu AuraGain

Experimental group

Description:

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

Treatment:

Device: Ambu AuraGain (size 1.5 or size 2.0)

LMA Supreme

Active Comparator group

Description:

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

Treatment:

Device: LMA Supreme (size 1.5 or size 2.0)