NCT07141498

Fiberoptic Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Devices in Pediatric Patients

Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Device Placement by Fiberoptic Bronchoscopy and Comparison of Gastric Insufflation Volumes Using Ultrasound in Pediatric Patient

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 1 Year – 8 Years
• Healthy volunteers: Accepted

Summary

This single-center, prospective, randomized controlled study aims to compare the placement accuracy of iGel and Air-Q sp3G supraglottic airway (SGA) devices in pediatric patients aged 1-8 years undergoing elective surgery under general anesthesia. Placement will be confirmed via fiberoptic bronchoscopy, and gastric insufflation will be assessed using ultrasound measurement of gastric antral cross-sectional area pre- and post-device placement. Secondary outcomes include postoperative complications such as sore throat, hoarseness and dysphagia.

Detailed description

This single-center, prospective, randomized controlled trial will be conducted in pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Participants will be randomized into two groups to receive either an iGel or an Air-Q sp3G device. Device placement will be confirmed intraoperatively via fiberoptic bronchoscopy using a standardized grading system and gastric antral cross-sectional area will be measured with ultrasound before device insertion, immediately after insertion and at the end of surgery to evaluate gastric insufflation. Secondary outcomes will include postoperative complications such as sore throat, hoarseness, dysphagia, mucosal bleeding, cough, laryngospasm, bronchospasm, nausea, vomiting and stridor. Intraoperative variables such as number of insertion attempts, ease of placement and peak airway pressure will also be recorded. The results are expected to identify which device offers better placement accuracy and lower gastric insufflation rates, thereby improving perioperative safety and postoperative recovery in pediatric patients.

Conditions

• Laryngeal Mask Airways
• Fiberoptic Bronchoscopy (FOB)
• Elective Surgeries
• Gastric Insufflation
• Gastric Ultrasound

Timeline

• Start date: 2025-08-28
• Primary completion: 2025-12-30
• Completion: 2026-01-09
• First posted: 2025-08-26
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)