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

NCT07019961 | Not Yet Recruiting

• 1 other identifier: KYLL-202502-002-01
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Surgery; General Anesthesia

Keywords

GMA-TULIP laryngeal mask; i-gel laryngeal mask; anatomical alignment of laryngeal mask; oropharyngeal leak pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (2)

G group

EXPERIMENTAL

Participants who will use the GMA-TULIP laryngeal mask

Device: the GMA-TULIP laryngeal mask

I Group

ACTIVE COMPARATOR

Participants who will use the i-gel laryngeal mask

Device: the i-gel laryngeal mask

Interventions

the GMA-TULIP laryngeal mask DEVICE

insert GMA-TULIP laryngeal masks after anesthesia induction

G group

the i-gel laryngeal mask DEVICE

insert i-gel laryngeal masks after anesthesia induction

I Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 70 years old. Patients undergoing trauma surgery in a supine position under general anesthesia.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

• Shaozhong Yang, Doctor

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Shaozhong Yang, Doctor

CONTACT

+86 18560083790; yszyang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 3, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)