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

S

Shandong University

Status

Not yet enrolling

Conditions

General Anesthesia
Trauma Surgery

Treatments

Device: the GMA-TULIP laryngeal mask
Device: the i-gel laryngeal mask

Study type

Interventional

Funder types

Other

Identifiers

NCT07019961
KYLL-202502-002-01

Details and patient eligibility

About

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.

Enrollment

198 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

198 participants in 2 patient groups

G group
Experimental group
Description:
Participants who will use the GMA-TULIP laryngeal mask
Treatment:
Device: the GMA-TULIP laryngeal mask
I Group
Active Comparator group
Description:
Participants who will use the i-gel laryngeal mask
Treatment:
Device: the i-gel laryngeal mask

Trial contacts and locations

1

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Central trial contact

Shaozhong Yang, Doctor

Data sourced from clinicaltrials.gov

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