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NCT Number: NCT07019961

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.

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Key information

Conditions

Trauma Surgery General Anesthesia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the GMA-TULIP laryngeal mask

Device

insert GMA-TULIP laryngeal masks after anesthesia induction

the i-gel laryngeal mask

Device

insert i-gel laryngeal masks after anesthesia induction

Primary outcomes

  1. Accuracy of anatomical alignment under fiberoptic bronchoscopy observation

    Time frame: 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 outcomes

  1. Number of laryngeal mask insertions

    Time frame: After anesthesia induction

  2. Placement time of laryngeal mask

    Time frame: After anesthesia induction

  3. Difficulty level of laryngeal mask insertion

    Time frame: After insertion of laryngeal mask

  4. Time of insertion of gastric tube through laryngeal mask airway

    Time frame: After insertion of laryngeal mask

  5. Number of gastric tube insertions

    Time frame: After insertion of laryngeal mask

  6. Difficulty level of gastric tube insertion

    Time frame: After insertion of laryngeal mask

  7. Oral and pharyngeal leakage pressure

    Time frame: 10 minutes after stable ventilation and 1 hour after ventilation

  8. Accuracy of anatomical alignment under fiberoptic bronchoscopy observation

    Time frame: 1 hour after ventilation and at the end of surgery

  9. Success rate of initial ventilation placement

    Time frame: During the anesthesia process

  10. Success rate of intraoperative ventilation

    Time frame: During the anesthesia process

  11. Number of laryngeal mask adjustments during surgery

    Time frame: During the anesthesia process

  12. Intraoperative injury situation

    Time frame: During the surgical process

  13. Postoperative respiratory complications

    Time frame: Immediately after anesthesia awakening, 1 hour later, 24 hours later

Study contacts

Contact information is provided by the study sponsor or research team.

Shaozhong Yang, Doctor

CONTACT

[email protected]

+86 18560083790

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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