Comparing Laryseal Pro and Ambu Aura Gain Devices for Fiberoptic Tracheal Intubation in Children Ages 4 to 8 A Randomized Controlled Study on Pediatric Airway Management

What this Trial Is About

Researchers are evaluating two extraglottic airway devices, Laryseal Pro and Ambu Aura Gain, as conduits for fiberoptic endotracheal intubation in children aged 4 to 8 years. The study aims to compare these devices in terms of the time required for endotracheal intubation and other clinical performance measures, focusing on improving airway management safety and effectiveness in pediatric patients undergoing general anesthesia. The trial involves two study groups one using the Ambu Aura Gain device and the other using the Laryseal Pro device for fiberoptic-guided endotracheal intubation. Both devices allow oxygenation while guiding the endotracheal tube into the airway, with features such as gastric access and design elements to improve safety and ease of intubation. This is a prospective randomized controlled study assessing device performance during surgeries lasting more than one hour under general anesthesia. Participants will be closely monitored during intubation procedures with assessments including intubation time, laryngeal view quality, airway seal pressure, success rates, number of attempts for device insertion and intubation, and any complications. The primary outcome is the time taken for fiberoptic-guided intubation. Safety and effectiveness will be evaluated throughout the study period, which runs until April 2026.

A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population