Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: the GMA-TULIP laryngeal mask, the i-gel laryngeal mask.
- Who it may be relevant to
- Registry conditions: Trauma Surgery, General Anesthesia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device the GMA-TULIP laryngeal mask
insert GMA-TULIP laryngeal masks after anesthesia induction - Device the i-gel laryngeal mask
insert i-gel laryngeal masks after anesthesia induction
Primary outcome measures
- Accuracy of anatomical alignment under fiberoptic bronchoscopy observation [Time frame: After insertion of laryngeal mask]
Secondary outcome measures (12)
- Number of laryngeal mask insertions [Time frame: After anesthesia induction]
- Placement time of laryngeal mask [Time frame: After anesthesia induction]
- Difficulty level of laryngeal mask insertion [Time frame: After insertion of laryngeal mask]
- Time of insertion of gastric tube through laryngeal mask airway [Time frame: After insertion of laryngeal mask]
- Number of gastric tube insertions [Time frame: After insertion of laryngeal mask]
- Difficulty level of gastric tube insertion [Time frame: After insertion of laryngeal mask]
- Oral and pharyngeal leakage pressure [Time frame: 10 minutes after stable ventilation and 1 hour after ventilation]
- Accuracy of anatomical alignment under fiberoptic bronchoscopy observation [Time frame: 1 hour after ventilation and at the end of surgery]
- Success rate of initial ventilation placement [Time frame: During the anesthesia process]
- Success rate of intraoperative ventilation [Time frame: During the anesthesia process]
- Number of laryngeal mask adjustments during surgery [Time frame: During the anesthesia process]
- Intraoperative injury situation [Time frame: During the surgical process]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT07019961 · KYLL-202502-002-01