Comparing Between Air-Q Intubating Laryngeal Airway and Ambu® AuraGain™ (NCT03130413) | Clinical Trial Compass
CompletedNot Applicable
Comparing Between Air-Q Intubating Laryngeal Airway and Ambu® AuraGain™
Malaysia64 participantsStarted 2016-11
Plain-language summary
The aim of this randomized study is conducted is to evaluate the performance and safety of air-Q intubating laryngeal airway as primary airway device in various short surgical procedure in children compared to Ambu® AuraGain™ Laryngeal Mask. Current Supraglottic airway devices (SADs) available in are classic LMA (cLMA), proseal LMA (pLMA), supreme LMA (sLMA) and the newer is Ambu® AuraGain™laryngeal mask. As variety of newer SADs for children have emerged since their introduction in clinical practice, hope the outcomes of this study it help advancing our knowledge and acumen in selecting appropriate devices for paediatric population.
Who can participate
Age range
1 Year – 6 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:
* Age between 1-6 years
* Weight 10-30kg
* American Society of Anesthesiologist (ASA) physical status class I and II
* Any surgical procedures where supraglottic airway (SGA) management is appropriate
* Duration of procedure within 2hours
Exclusion Criteria:
* Active respiratory infection
* Anticipated and known difficult airway
* Lung disease requiring high airway pressure
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
1
measure fibreoptic (FO) grade of laryngeal view
Timeframe: 5 minutes after insertion of the device when good tidal volume is achieved