Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

Schulthess Klinik

Status: Unknown

Conditions: Airway Morbidity

Treatments: Procedure: function tests; Device: LMA SupremeTM; Device: Ambu-Aura GainTM

Study type: Interventional

Funder types: Other

Identifiers

NCT02458794

Schulthess_Anä_5

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Difficult airway
• Non fasted
• BMI > 35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 2 patient groups

LMA SupremeTM

Active Comparator group

Description:

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Treatment:

Procedure: function tests

Device: LMA SupremeTM

Ambu-Aura GainTM

Active Comparator group

Description:

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Treatment:

Device: Ambu-Aura GainTM

Procedure: function tests