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

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Completed
• CT.gov ID: NCT03933644
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oropharyngeal Leak Pressure	Device: Gastric Tube; Device: No gastric Tube	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
• Actual Study Start Date: May 15, 2019
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Feb 12, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Oropharyngeal Leak Pressure [immediately after insertion]

   after insertion

Secondary Outcome Measures

1. Oropharyngeal Leak Pressure [15 minutes]

   after 15 minutes

2. Oropharyngeal Leak Pressure [30 minutes]

   after 30 minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MUInnsbruck	Innsbruck		Austria

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT03933644
• Other Study ID Numbers: Zahnlos
• First Posted: May 1, 2019
• Last Update Posted: Nov 23, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 23, 2020