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

Not Applicable

Completed

• Conditions: Oropharyngeal Leak Pressure
• Interventions: Device: Gastric Tube; Device: No gastric Tube

• Registration Number: NCT03933644
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-01
• Study Start: 2019-05-15
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu Aura Gain TM with gastric tube	Gastric Tube	-
Ambu Aura Gain TM without gastric tube	No gastric Tube	-

Primary Outcome Measures

Name	Time	Method
Oropharyngeal Leak Pressure	immediately after insertion	after insertion

Secondary Outcome Measures

Name	Time	Method
Oropharyngeal Leak Pressure	30 minutes	after 30 minutes

Trial Locations

Locations (1)

MUInnsbruck; 🇦🇹 Innsbruck, Austria