Clinical trial NCT07019961: Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
Official title: Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma Surgery
General Anesthesia
Keywords: GMA-TULIP laryngeal mask
i-gel laryngeal mask
anatomical alignment of laryngeal mask
oropharyngeal leak pressure
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
timeFrame: After insertion of laryngeal mask
Secondary outcomes:
measure: Number of laryngeal mask insertions
timeFrame: After anesthesia induction
measure: Placement time of laryngeal mask
timeFrame: After anesthesia induction
measure: Difficulty level of laryngeal mask insertion
timeFrame: After insertion of laryngeal mask
measure: Time of insertion of gastric tube through laryngeal mask airway
timeFrame: After insertion of laryngeal mask
measure: Number of gastric tube insertions
timeFrame: After insertion of laryngeal mask
measure: Difficulty level of gastric tube insertion
timeFrame: After insertion of laryngeal mask
measure: Oral and pharyngeal leakage pressure
timeFrame: 10 minutes after stable ventilation and 1 hour after ventilation
measure: Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
timeFrame: 1 hour after ventilation and at the end of surgery
measure: Success rate of initial ventilation placement
timeFrame: During the anesthesia process
measure: Success rate of intraoperative ventilation
timeFrame: During the anesthesia process
measure: Number of laryngeal mask adjustments during surgery
timeFrame: During the anesthesia process
measure: Intraoperative injury situation
timeFrame: During the surgical process
measure: Postoperative respiratory complications
timeFrame: Immediately after anesthesia awakening, 1 hour later, 24 hours later
Other outcomes:
Locations:
city: Jinan,
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Shaozhong Yang, Doctor
role: STUDY_CHAIR
References: