Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
NCT ID: NCT07019961
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
198 participants
INTERVENTIONAL
2025-07-01
2025-12-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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G group
Participants who will use the GMA-TULIP laryngeal mask
the GMA-TULIP laryngeal mask
insert GMA-TULIP laryngeal masks after anesthesia induction
I Group
Participants who will use the i-gel laryngeal mask
the i-gel laryngeal mask
insert i-gel laryngeal masks after anesthesia induction
Interventions
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the GMA-TULIP laryngeal mask
insert GMA-TULIP laryngeal masks after anesthesia induction
the i-gel laryngeal mask
insert i-gel laryngeal masks after anesthesia induction
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Principal Investigators
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Shaozhong Yang, Doctor
Role: STUDY_CHAIR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KYLL-202502-002-01
Identifier Type: -
Identifier Source: org_study_id
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