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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the GMA-TULIP laryngeal mask, a device used to help patients breathe during trauma surgery while they are under general anesthesia. The researchers want to find out if the GMA-TULIP fits better and works more effectively than another commonly used device called the i-gel laryngeal mask. They will look at how well the GMA-TULIP works in patients lying on their backs for surgery and will gather feedback from participants about their experience right after anesthesia and then again one hour and 24 hours later.

To be eligible for this study, you need to be between 18 and 70 years old and scheduled for trauma surgery in a supine position (lying on your back) under general anesthesia. You should also have a body mass index (BMI) between 18 and 35 and be in good health according to the American Society of Anesthesiologists grading. However, if you have a history of difficult airways or certain medical conditions, you may not be able to participate. If you join, you’ll be helping researchers learn more about airway management during surgery, which could improve safety and comfort for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years old ≤ age ≤ 70 years old. Patients undergoing trauma surgery in a supine position under general anesthesia.
• • 18 kg/m2 ≤ BMI ≤ 35 kg/m2. American Society of Anesthesiologists (ASA) grades I-III. Can understand the research process and the use of pain scales. Clear understanding and voluntary participation in the study, signing of informed consent form.
• Exclusion Criteria:
• • Patients with known or predicted difficult airways. High risk of reflux or aspiration (e.g., gastroesophageal reflux disease patients).
• • Individuals with active upper respiratory tract infections. Cervical related diseases or surgical history. Preoperative sore throat or previous sore throat or hoarseness. Patients with oral and maxillofacial trauma or fractures. Other reasons why researchers believe it is not appropriate to participate in the experiment.