NCT06853756

Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia

Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.

Detailed description

Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs). Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.

Conditions

• Gastric Insufflation
• I-gel
• Ambu AuraGain
• Pediatric
• Orthopedic Operations
• General Anesthesia

Interventions

Type	Name	Description
DEVICE	Ambu Auragain	Ambu Auragain was inserted after induction.
DEVICE	I-gel	The I-gel device was inserted after induction.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-03-27
• Completion: 2025-03-27
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: Egypt