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ClinicalTrials.gov ID

NCT02458794

Lead Sponsor

Schulthess KlinikOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Jul 29, 2015Estimated

Start Date

Sep 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Apr 2016Estimated

Official Title

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

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.

• Airway Morbidity

• function tests
• LMA SupremeTM
• Ambu-Aura GainTM

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Difficult airway
• Non fasted
• BMI > 35

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Single

Lead Sponsor

Schulthess KlinikOTHER

Collaborators

Krankenhaus BozenOTHER

christian.keller@kws.ch+41443857462