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

Condition(s) studied

Investigational drug(s) / intervention(s)

the GMA-TULIP laryngeal mask: insert GMA-TULIP laryngeal masks after anesthesia induction

the i-gel laryngeal mask: insert i-gel laryngeal masks after anesthesia induction

Study 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

Primary outcome measure(s)

• Accuracy of anatomical alignment under fiberoptic bronchoscopy observation — 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.

Trial sites (1)

More Qilu Hospital of Shandong University trials in China

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