Comparing Laryseal Clear and Ambu Aura40 Laryngeal Mask Airway Devices in Preschool Children Undergoing Surgery

What this Trial Is About

Researchers are evaluating the clinical performance of two supraglottic airway devices, Laryseal Clear and Ambu Aura40 laryngeal masks, in preschool children undergoing surgery. The study focuses on children aged 3 to 6 years and aims to compare the effectiveness and safety of these devices, which are used to maintain the airway during anesthesia and may cause less stress and fewer complications than traditional methods. This research is conducted at Zagazig University hospitals in their anesthesia and intensive care departments. The study involves randomly assigning children into two groups one group uses the LarySeal Clear device while the other uses the Ambu Aura40 device. Both devices are sized according to the childs weight and inserted following manufacturer guidelines, with differences in head positioning and insertion technique. Anesthesia is induced with sevoflurane and intravenous medications, and the devices are inserted after ensuring proper anesthesia depth. Device placement is confirmed by monitoring oxygen levels, chest movement, and ventilation, with up to three attempts allowed before switching to an endotracheal tube if needed. During the study, children will be closely monitored with standard anesthesia equipment and assessed for airway device performance, including leak pressure measurements and ease of insertion. Researchers will also observe and record any complications during and after surgery, such as coughing, airway obstruction, or trauma. Follow-up includes evaluation in the post-anesthesia care unit and up to 24 hours after the procedure to check for any related side effects. Participation lasts through the surgical procedure and immediate recovery period, with safety and device effectiveness as primary outcomes.

Clinical Performance of Laryseal Clear Versus Ambu Aura 40 Laryngeal Mask Airway for Preschool Children