CompletedNot Applicable

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

Malaysia90 participantsStarted 2024-07-26

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients (age 18 to 65 years) of either sex, who are scheduled for an elective surgery under general anaesthesia * Patients with ASA physical status of I or II. Exclusion Criteria: * Patients with anticipated difficult airway (Airway Difficulty Score \>8) * Patients with high risk of aspiration and regurgitation * Patients with body mass index (BMI) \> 40kg/m2 * Patients who exhibit evidence of upper respiratory tract infection * Patients with history of radiotherapy to the neck * Patients who are pregnant * Patients who are unable or unwilling to consent for the study * Patients who are mentally challenged and unable to understand the study instructions * Planned operating time more than 4 hours

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oropharyngeal leak pressure (OLP) of the Air-Q3 and Ambu AuraGain supraglottic airway device

Timeframe: After induction of general anaesthesia until successful insertion of supraglottic airway device

Trial details

NCT IDNCT06914453

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-24

View on ClinicalTrials.gov More Oropharyngeal Leak Pressure trials