A Randomised Controlled Trial to Compare Two Supraglottic Airway Devices (Ambu AuraGain vs Air Q-3) in Terms of Performance Characteristics.

Summary

A supraglottic airway device (SAD) functions as a temporary device to maintain the patency of airway during the administration of anaesthesia. The Ambu AuraGain (Ambu, Ballerup, Denmark) is a second generation SAD, since introduced in 2014, has been widely used in clinical practice. The Ambu AuraGain is an anatomically curved, single-use supraglottic airway device that features a port for orogastric tube insertion and it is a conduit for intubation as well. It is also associated with fast insertion times and high seal pressures. The Air-Q3, on the other hand, is relatively new SAD, however rather similar to Ambu AuraGain, it is also anatomically curved with a built-up mask heel for improved seal and it serves as a conduit for intubation as it features a unique endotracheal tube ramp and epiglottis elevator which aids in fast easy and safe intubation. It also features a port for orogastric tube insertion. Given the relatively recent introduction of the Air-Q3 into the market, there exists a paucity of comprehensive data regarding its efficacy. Meanwhile, the Ambu AuraGain stands as one of the most frequently utilised SAD, especially in our centre. This randomized controlled trial aims to compare the performance characteristics of the Ambu AuraGain and Air Q-3 in 90 patients undergoing surgery under general anaesthesia. The primary objective is to evaluate oropharyngeal leak pressure (OLP), while secondary objectives includes time to insertion, first-pass success rate, ease of orogastric tube (OGT) insertion, laryngeal alignment using a fiberoptic scope, and incidence of postoperative complications.

Conditions

• Oropharyngeal Leak Pressure
• Supraglottic Airway
• Elective Surgery
• General Anaesthesia

Interventions

DEVICE

Air Q-3 Supraglottic Airway Device

Oropharyngeal leak pressure and other performance characteristics including time to insertion, first-pass success rate, ease of orogastric tube (OGT) insertion, laryngeal alignment using a fiberoptic scope, and incidence of postoperative sore throat.

DEVICE

Ambu AuraGain Supraglottic Airway Device

Oropharyngeal Leak Pressure and other performance characteristics including time to insertion, first-pass success rate, ease of orogastric tube (OGT) insertion, laryngeal alignment using a fiberoptic scope, and incidence of postoperative sore throat.

Sponsors & Collaborators

• University of Malaya

  lead OTHER

Principal Investigators

• Ina Ismiarti Shariffuddin, Clinical Professor · Univerisity Malaya

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-26

Primary Completion

2025-01-24

Completion

2025-01-24

Countries

• Malaysia