NCT02380768

A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 3 Months – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Supraglottic Airway

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-03-05
• Last updated: 2015-07-20

Locations

1 site across 1 country: United States