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

Medical University Innsbruck

Status: Completed

Conditions: Oropharyngeal Leak Pressure

Treatments: Device: Gastric Tube; Device: No gastric Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT03933644

Zahnlos

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Ambu Aura Gain TM with gastric tube

Other group

Treatment:

Device: Gastric Tube

Ambu Aura Gain TM without gastric tube

Other group

Treatment:

Device: No gastric Tube