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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: General Anesthesia; Trauma Surgery
• Intervention / Treatment: Device: the GMA-TULIP laryngeal mask; Device: the i-gel laryngeal mask

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaozhong Yang, Doctor; Phone Number: +86 18560083790; Email: yszyang@163.com

Study Locations

• China
  • Shandong
    • Jinan,, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Shaozhong Yang, Doctor; Phone Number: +86 18560083790; Email: yszyang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G group; Participants who will use the GMA-TULIP laryngeal mask	Device: the GMA-TULIP laryngeal mask; insert GMA-TULIP laryngeal masks after anesthesia induction
Active Comparator: I Group; Participants who will use the i-gel laryngeal mask	Device: the i-gel laryngeal mask; insert i-gel laryngeal masks after anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation	Class I: Vocal cords visible. Class II: Vocal cords and posterior epiglottis visible. Class III: Vocal cords and anterior epiglottis visible, <50% visual obstruction of epiglottis to vocal cords. Class IV: Vocal cords and anterior epiglottis visible, >50% visual obstruction of epiglottis to vocal cords. Class V: Vocal cords not visible. We define Class I and II field of view as accurate alignment; Class III and IV vision are defined as poor alignment; Class V vision is defined as alignment failure.	After insertion of laryngeal mask

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of laryngeal mask insertions	After anesthesia induction
Placement time of laryngeal mask	After anesthesia induction
Difficulty level of laryngeal mask insertion	After insertion of laryngeal mask
Time of insertion of gastric tube through laryngeal mask airway	After insertion of laryngeal mask
Number of gastric tube insertions	After insertion of laryngeal mask
Difficulty level of gastric tube insertion	After insertion of laryngeal mask
Oral and pharyngeal leakage pressure	10 minutes after stable ventilation and 1 hour after ventilation
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation	1 hour after ventilation and at the end of surgery
Success rate of initial ventilation placement	During the anesthesia process
Success rate of intraoperative ventilation	During the anesthesia process
Number of laryngeal mask adjustments during surgery	During the anesthesia process
Intraoperative injury situation	During the surgical process
Postoperative respiratory complications	Immediately after anesthesia awakening, 1 hour later, 24 hours later

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Chair: Shaozhong Yang, Doctor, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 3, 2025

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: oropharyngeal leak pressure; GMA-TULIP laryngeal mask; i-gel laryngeal mask; anatomical alignment of laryngeal mask
• Other Study ID Numbers: KYLL-202502-002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the research is completed, share research data, research plans, statistical analysis plans, informed consent forms, and other data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No