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

Schulthess Klinik2 sites in 2 countries200 target enrollmentSeptember 2015

ConditionsAirway Morbidity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Airway Morbidity
Sponsor: Schulthess Klinik
Enrollment: 200
Locations: 2
Primary Endpoint: oropharyngeal seal pressure
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

April 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Schulthess Klinik

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ASA 1 or 2
•Age 19-65 yr
•Written informed consent

Exclusion Criteria

•Difficult airway
•Non fasted
•BMI \> 35

Outcomes

Primary Outcomes

oropharyngeal seal pressure

Time Frame: 5 minutes

Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).