Clinical effects of the use of a novel oropharyngeal airway in painless gastroscopy in patients with obstructive sleep apnoea-hypopnoea syndrome: a randomised controlled trial protocol.

Abstract

Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) is a sleep-related breathing disorder characterised by partial or complete obstruction of the upper respiratory tract. Owing to their relevant physiological anatomy, patients with OSAHS often experience severe respiratory complications, such as airway obstruction and hypoxaemia, during painless gastroscopy. In addition, the use of the shared airway approach increases the difficulty of airway management. At present, simple and effective tools for airway management for use during gastroscopy in clinical practice are lacking. Therefore, the aim of this study is to investigate whether a novel oropharyngeal airway designed for use in endoscopy can effectively relieve airway obstruction and prevent hypoxaemia. In this prospective, randomised, controlled clinical study, 130 patients with OSAHS diagnosed via polysomnography monitoring will be randomly divided into two groups. The experimental group will receive the novel oropharyngeal airway, whereas the control group will receive a conventional bite block. The primary outcome will be the incidence of hypoxia (75%≤SpO₂ (pulse oxygen saturation)<90%, ≤60 s), and the secondary outcome measure will be the incidence of severe hypoxia (SpO₂<75% or 75%≤SpO₂<90%, ≥60 s). The rate of airway intervention, the doses of additional drugs used during the operation, endoscopist and patient satisfaction with the procedure, and the incidence of various adverse events will be recorded. The Institutional Review Committee of the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) approved the experimental protocol on 22 August 2024 (ethics number: YXLL-KY-2024(084)). The results of this study will be reported in peer-reviewed journals and relevant academic conferences or related research platforms. NCT06594380.