Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia… (NCT07019961) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
China198 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation