CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Air Q-3 Supraglottic Airway Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06914453
NCT06914453N/ACompleted

A Comparative Study of Air-Q3 and Ambu AuraGain Supraglottic Airway Device in Patients Undergoing Elective Surgery Under General Anaesthesia: A Randomised Controlled Trial

University of Malaya·interventional·Posted Apr 6, 2025·Updated Apr 9, 2025

In Brief

A clinical study evaluating Air Q-3 Supraglottic Airway Device and Ambu AuraGain Supraglottic Airway Device for Oropharyngeal Leak Pressure and 3 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedApr 6, 2025
Enrollment StartJul 26, 2024
Primary CompletionJan 24, 2025
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.2 years ago

Interventions

Air Q-3 Supraglottic Airway Devicedevice

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.

Ambu AuraGain Supraglottic Airway Devicedevice

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.