Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

Not Applicable

• Conditions: Airway Morbidity
• Interventions: Procedure: function tests; Device: LMA SupremeTM; Device: Ambu-Aura GainTM

• Registration Number: NCT02458794
• Lead Sponsor: Schulthess Klinik

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29
• Study Start: 2015-09
• Primary Completion: 2016-03
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Difficult airway
• Non fasted
• BMI > 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ambu-Aura GainTM	function tests	function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
LMA SupremeTM	function tests	function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
LMA SupremeTM	LMA SupremeTM	function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
Ambu-Aura GainTM	Ambu-Aura GainTM	function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Primary Outcome Measures

Name	Time	Method
oropharyngeal seal pressure	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).

Secondary Outcome Measures

Name	Time	Method
anatomic position	5 minutes	The anatomic position was assessed by passing a fiberoptic scope through the airway tube stopping 0,5 cm prior to the end of the tube. The airway tube view was scored using an established scoring system.

Trial Locations

Locations (2)

Schulthess Klinik; 🇨🇭 Zürich, Switzerland

Zentralkrankenhaus Bozen; 🇮🇹 Bozen, Italy