Non-Crossover Study of the LMA Protector Versus Ambu AuraGain

Schulthess Klinik

Status: Completed

Conditions: Airway Morbidity

Treatments: Device: Ambu AuraGainTM; Device: LMA ProtectorTM; Procedure: function tests

Study type: Interventional

Funder types: Other

Identifiers

NCT02820792

Schulthess_Anä_8

Details and patient eligibility

About

The LMA ProtectorTM 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 study the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and the Ambu AuraGainTM in paralyzed, anesthetized patients.

Enrollment: 96 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: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

LMA ProtectorTM

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 ProtectorTM

Ambu AuraGainTM

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: Ambu AuraGainTM