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NCT06914453
A Randomised Controlled Trial to Compare Two Supraglottic Airway Devices (Ambu AuraGain vs Air Q-3) in Terms of Performance Characteristics.
NA trial testing Air Q-3 Supraglottic Airway Device in Oropharyngeal Leak Pressure in 90 participants. Completed in 24 January 2025.
24 January 2025
Quick facts
| Lead sponsor | University of Malaya |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 90 |
| Start date | 26 July 2024 |
| Primary completion | 24 January 2025 |
| Estimated completion | 24 January 2025 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Air Q-3 Supraglottic Airway Device
- Ambu AuraGain Supraglottic Airway Device
Conditions studied
- Oropharyngeal Leak Pressure — all drugs for Oropharyngeal Leak Pressure →
- Supraglottic Airway — all drugs for Supraglottic Airway →
- Elective Surgery — all drugs for Elective Surgery →
- General Anaesthesia — all drugs for General Anaesthesia →
Sponsor
University of Malaya
Who can join
Adults 18 to 65, any sex, with Oropharyngeal Leak Pressure or Supraglottic Airway. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06914453
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Related trials
Other recruiting trials for Oropharyngeal Leak Pressure
Currently open trials in the same condition.
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Other University of Malaya trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06914453 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Malaya
- Last refreshed: 9 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06914453.
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