Evaluation of the Ambu® AuraGain in Ambulatory Surgery

Hospital General Universitario Gregorio Marañon

Status: Completed

Conditions: Airway

Treatments: Device: Ambu® AuraGainTM

Study type: Observational

Funder types: Other

Identifiers

NCT04501068

MULTIAURAGAIN

Details and patient eligibility

About

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist

Full description

Supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup, Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated gastric access port designed to provide functional separation of the respiratory and digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to manage gastric contents.

Its characteristics in the design, composition by a smooth and atraumatic material, the presence of the gastric drainage access, with potential improved patient safety and its characteristic of being disposable, suggests a significant expansion of its use in the coming years.

The series in the literature reporting performance or safety of use of the Ambu® AuraGainTM come from studies on selected cases and in certain surgical procedures. However, there are limited studies that have evaluated the efficacy of the device in routine clinical practice in patients intervened in ambulatory surgery and performed by a single investigator.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices.
• ASA physical status I-III patients
• Age 18-no limit

Exclusion criteria

• Patients with known difficult airway
• Patients with increased risk of aspiration
• Patient refusal to participate in the study

Trial design

150 participants in 1 patient group

Ambu AuraGain

Description:

Ambu® AuraGainTM Patients undergoing anesthesia in which airway management includes a Ambu® AuraGainTM supraglottic airway and fulfill the inclusion criteria of the study.

Treatment:

Device: Ambu® AuraGainTM