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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
198
insert GMA-TULIP laryngeal masks after anesthesia induction
insert i-gel laryngeal masks after anesthesia induction
Qilu Hospital of Shandong University
Jinan, Shandong, China
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.
Time frame: After insertion of laryngeal mask
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
Postoperative respiratory complications
Time frame: Immediately after anesthesia awakening, 1 hour later, 24 hours later
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