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

Oropharyngeal Leak Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933644
• Other study ID #: Zahnlos
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: November 2020
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Leak Pressure

Intervention

Device:
• Gastric Tube
SGA is inserted with a gastric tube as guide for insertion
• No gastric Tube
SGA is inserted without a gastric tube as guide for insertion

Locations

Country	Name	City	State
Austria	MUInnsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal Leak Pressure	after insertion	immediately after insertion
Secondary	Oropharyngeal Leak Pressure	after 15 minutes	15 minutes
Secondary	Oropharyngeal Leak Pressure	after 30 minutes	30 minutes