Application of a novel gastro-laryngeal mask in upper gastrointestinal endoscopy surgery: A pilot randomized clinical trial

Background

The Gastro-Laryngeal Mask (Jcerity Endoscoper™ Airway) is a new airway management technique utilized in patients undergoing upper gastrointestinal endoscopy surgery under general anesthesia, but evidence of its effectiveness and safety is scarce.

Objective

To assess the success rate of insertion, cardiovascular response, airway pressure, time taken for placement, nausea or vomiting, pharyngodynia, and other complications of using the new type of back-open gastroscopy laryngeal mask.

Methods

We screened 1401 patients; 105 were ineligible, and 40 declined to participate. Participants were randomly allocated into the Jcerity Endoscoper™ Airway (JEA) group and the endotracheal tube (ET) group. Among them, 1266 patients were randomly assigned to receive endotracheal intubation (n = 633) or JEA (n = 633).

Results

Compared with the ET group, the JEA group had a significantly shorter insertion time and less cardiovascular response during insertion. The time taken for extubation after anesthesia and residence time in PACU in the JEA group was shorter than in the ET group. Especially, the incidence of pharyngodynia in the JEA group was lower than that in the ET group. The satisfaction of endoscopists with the JEA reached 99.4%.

Conclusions

This study showed that the back-open JEA can not only provide a safe and effective airway guarantee for patients but also provide convenience for gastroenterologists to carry out endoscopic operations.

Trial Registration

The trial was registered before patient enrollment at the Chinese Clinical Trial Registry Center (ChiCTR2100046864, principal investigator: Yunqi Lv, date of registration: 2021-05-29). The study was conducted in the painless diagnosis and treatment center of the First Affiliated Hospital of Zhengzhou University from June 2021 to October 2023 (Date of enrolment of the first research participant:2021-06-01).