NCT02458794

Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.

Conditions

• Airway Morbidity

Interventions

Type	Name	Description
PROCEDURE	function tests	ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
DEVICE	LMA SupremeTM
DEVICE	Ambu-Aura GainTM

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2015-06-01
• Last updated: 2015-07-29

Locations

2 sites across 2 countries: Italy, Switzerland