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

Not Applicable

Not yet recruiting

• Conditions: Trauma Surgery; General Anesthesia

• Registration Number: NCT07019961
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation	After insertion of laryngeal mask	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative respiratory complications	Immediately after anesthesia awakening, 1 hour later, 24 hours later
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

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan,, Shandong, China