Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

Airway Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02458794
• Other study ID #: Schulthess_Anä_5
• Status: Not yet recruiting
• Phase: N/A
• First received: May 20, 2015
• Last updated: July 27, 2015
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Schulthess Klinik
• Contact: Christian Keller, MD MSc
• Phone: ++41443857462
• Email: christian.keller[@]kws.ch
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA 1 or 2

• Age 19-65 yr

• Written informed consent

Exclusion Criteria:

• Difficult airway

• Non fasted

• BMI > 35

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

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

Device:
• LMA SupremeTM

• Ambu-Aura GainTM

Locations

Country	Name	City	State
Italy	Zentralkrankenhaus Bozen	Bozen
Switzerland	Schulthess Klinik	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	Krankenhaus Bozen

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oropharyngeal seal pressure	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).	5 minutes	Yes
Secondary	anatomic position	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.	5 minutes	Yes