NCT07019961

Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if GMA-TULIP laryngeal mask willfit well in the right place in participants undergoing trauma surgery in a supine position under general anaesthesia. It will also learn about the convenience, effectiveness and safety of the GMA-TULIP laryngeal mask. The main questions it aims to answer are: Does the GMA-TULIP laryngeal mask exhibit better anatomical alignment? Does the GMA-TULIP laryngeal mask perform effectively in trauma surgery patients in a supine position under general anaesthesia? Researchers will compare with the i-gel laryngeal mask (a device already popular among anaesthetists) to see if the GMA-TULIP laryngeal mask works to have a good performance in general anaesthesia. Participants will describe feelings immediately after anesthesia， 1 hour later and 24 hours later.

Conditions

• Trauma Surgery
• General Anesthesia

Interventions

Type	Name	Description
DEVICE	the GMA-TULIP laryngeal mask	insert GMA-TULIP laryngeal masks after anesthesia induction
DEVICE	the i-gel laryngeal mask	insert i-gel laryngeal masks after anesthesia induction

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-01
• Completion: 2025-12-03
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: China