Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA.

It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP).

The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA.

The study also evaluates the OLP after 15 minutes and after 30 minutes.

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Leak Pressure
• Intervention / Treatment: Device: Gastric Tube; Device: No gastric Tube

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • MUInnsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I - 3
• Signed informed consent
• Age 18 - 90 years
• Edentolous (or partial) patients
• Patients scheduled for elective surgery

Exclusion Criteria:

• Patients with a known or predicted difficult airway
• Patients with anatomical disorders in the upper airway, the oesophagus or the trachea
• Patients at risk for aspiration
• Body mass index (BMI) > 40 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ambu Aura Gain TM with gastric tube	Device: Gastric Tube; SGA is inserted with a gastric tube as guide for insertion
Other: Ambu Aura Gain TM without gastric tube	Device: No gastric Tube; SGA is inserted without a gastric tube as guide for insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal Leak Pressure	after insertion	immediately after insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal Leak Pressure	after 15 minutes	15 minutes
Oropharyngeal Leak Pressure	after 30 minutes	30 minutes

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Lukas Gasteiger, Dr, Departement for Anaesthesia and Intensive Care - Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Zahnlos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No