Active — Not RecruitingNot Applicable

Comparative Evaluation of Ambu AuraGain, LarySeal Pro and I-gel in Pediatric Airway Management for Day-Case Surgery Under Controlled Ventilation

Egypt165 participantsStarted 2026-01-01

Plain-language summary

This study aims to compare the Ambu AuraGain, LarySeal Pro LMA, and i-gel regarding their insertion characteristics, ventilation efficacy, risk of gastric insufflation, fiberoptic view quality, intraoperative and postoperative airway-related complications, and hemodynamic stability.165 consecutive pediatric patients aged 2-9 years, weighing 10-30 kg, American Society of Anesthesiologists (ASA) physical status I or II, and scheduled for elective day-case surgery suitable for supraglottic airway device (SGAD) use.Patients will be randomly assigned (n= 55 per group) using a computer-generated random number sequence (www.random.org) to one of three groups: * Group I: Ambu® AuraGain TM (Ambu Ltd Xiang Yu Xiamen, Fujian, China) * Group II: LarySeal Pro® LMA (Flexicare Medical Limited, Cynon Valley Business Park, Mountain Ash, UK).Patients will receive oral midazolam before anesthesia, followed by standard monitoring, induction with sevoflurane, fentanyl, and atracurium, and insertion of an appropriately sized SGAD by experienced anesthesiologists. Ventilation quality, oropharyngeal leak pressure (OLP), peak airway pressure (Ppeak), fiberoptic glottic view, and gastric insufflation by ultrasound will be assessed. Anesthesia will be maintained with controlled ventilation and cuff pressure adjusted to 60 cmH₂O. At the end, neuromuscular blockade will be reversed, devices removed upon awakening, and patients observed for complications such as laryngospasm, Outcome parameter (s): * Oropharyngeal Leak Pressure (OLP). * Demographic and Clinical Data. * Hemodynamics. * Insertion Data. * Peak Airway Pressure (Ppeak). * Fiberoptic Glottic View Assessment. * Ultrasound Assessment of Gastric Insufflation. * Perioperative Complications.bronchospasm, or sore throat. * Group III: I-gelTM (Intersurgical Ltd, Berkshire, RG41 2RZ, UK).

Who can participate

Age range

2 Years – 9 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 2-9 years. * Weight 10-30 kg. * ASA Physical Status I or II. * Elective day-case surgery requiring general anesthesia with controlled ventilation using an SGAD. * Written informed consent from parent(s) or legal guardian(s). Exclusion Criteria: * • ASA Physical Status III or IV. * Known or predicted difficult airway. * History of significant respiratory disease (e.g., asthma requiring frequent medication, active upper respiratory tract infection, reactive airway disease within the past month). * History of significant gastroesophageal reflux, hiatal hernia, BMI ≥ 35, or other conditions predisposing to increased aspiration risk. * Neuromuscular disorders affecting airway patency or respiratory function. * Known allergy or contraindication to study devices or anesthetic medications. * Participation in other clinical trials that could influence study outcomes.

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)

Timeframe: from enrollment to the end of the study at 6 months

Trial details

NCT IDNCT07274280

SponsorKasr El Aini Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

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