Comparison of Gastric Insufflation With the Classic Igel Laryngeal Mask and the New Igelplus Laryngeal Mask Using Gastric Ultrasound

This study aims to compare the effectiveness and safety of two types of laryngeal masks- iGel and iGel Plus, used during elective surgeries. The focus is on evaluating differences in gastric insufflation and ventilation parameters between these two devices. Participants will be patients classified as ASA 1-2 with a BMI of less than 35, undergoing elective procedures. The study is designed as a prospective, randomized, controlled trial with 200 subjects divided evenly between the two laryngeal mask groups. Key outcomes include gastric cross-sectional area (CSA) measurements before and after surgery, ventilation metrics such as leakage pressure and PEEP, and the incidence of postoperative complications like nausea and respiratory issues.

NCT Number	NCT06578598
Lead Sponsor	Luzerner Kantonsspital
Conditions	Surgery, Anesthesia
Enrollment	200 participants
Start Date	2024-10-01
Primary Completion	2025-10-01 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2024-08-29