Non-Crossover Study of the LMA Protector Versus Ambu AuraGain

Airway Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820792
• Other study ID #: Schulthess_Anä_8
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: January 25, 2017
• Start date: September 2016
• Est. completion date: December 20, 2016

Study information

• Verified date: January 2017
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 20, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

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

Device:
• LMA ProtectorTM

• Ambu AuraGainTM

Locations

Country	Name	City	State
Switzerland	Christian Keller MD, M.Sc.	Zürich
Switzerland	Schulthess Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oropharyngeal leak 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 min
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 min