NCT07274280

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Airway Control

Interventions

Type	Name	Description
DEVICE	supraglottic airway device	use of supraglottic airway device as an airway control device for pediatric patients during day case surgery under controlled ventilation

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-30
• Completion: 2026-07-15
• First posted: 2025-12-10
• Last updated: 2025-12-16

Locations

1 site across 1 country: Egypt