二氧化碳监测降低老年患者在异丙酚镇静下接受胃肠内镜检查时缺氧的发生率：一项多中心随机对照试验的研究方案。
Capnographic monitoring reduces hypoxia incidence in older patients undergoing gastrointestinal endoscopy under propofol sedation: study protocol for a multicenter randomized controlled trial.
机构信息
Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
出版信息
Trials. 2023 Mar 15;24(1):192. doi: 10.1186/s13063-023-07208-0.
BACKGROUND
Hypoxia is a very common adverse event that occurs during gastrointestinal endoscopy under sedation, especially in older patients, owing to limited reservation of heart, brain, lung, and other organs. Prolonged or severe hypoxia can cause ischemia of the coronary artery and permanent nervous system damage, and even result in death. Hence, it is imperative to reduce or prevent hypoxia during gastrointestinal endoscopy under sedation in older patients. Although several oxygen delivery methods would reduce hypoxia during this procedure, early detection of respiratory depression and early administration of intervention would be the best method to reduce or even confirm the hypoxia. Capnographic monitoring is reportedly more sensitive for detecting respiratory depression before the onset of hypoxia than the current clinical routine monitoring of pulse oxygen saturation; however, its effect is controversial. Therefore, in this study, we aimed to improve the safety of gastrointestinal endoscopy under sedation in older patients.
METHODS
A multicenter, randomized, single-blind, two-arm parallel-group, controlled with an active comparator, interventional superiority clinical trial will be conducted to evaluate the impact of an additional capnographic monitoring-based intervention on the incidence of hypoxia in older patients. Patients (n = 1800) scheduled for gastrointestinal endoscopy with propofol sedation will be randomly assigned to either a control or interventional arm, wherein standard or capnographic monitoring is implemented, respectively.
DISCUSSION
This study primarily aims to examine whether an additional capnographic monitoring-based intervention can reduce the incidence of hypoxia in older patients during gastrointestinal endoscopy under propofol and sufentanil sedation. The results of this study may extensively impact gastrointestinal endoscopy under sedation and the development of associated guidelines.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05030870. Registered on September 1, 2021.
背景
在镇静下进行胃肠内镜检查时，缺氧是一种非常常见的不良事件，尤其是在老年患者中，由于心脏、大脑、肺和其他器官的储备有限。长时间或严重的缺氧可导致冠状动脉缺血和永久性神经系统损伤，甚至导致死亡。因此，在老年患者镇静下进行胃肠内镜检查时，必须减少或预防缺氧。尽管几种供氧方法可以减少该过程中的缺氧，但早期发现呼吸抑制并及早进行干预将是减少甚至确定缺氧的最佳方法。与当前临床常规监测脉搏血氧饱和度相比，呼气末二氧化碳监测据称更能早期发现缺氧前的呼吸抑制；然而，其效果存在争议。因此，在这项研究中，我们旨在提高老年患者镇静下胃肠内镜检查的安全性。
方法
一项多中心、随机、单盲、两臂平行组、以活性对照物为对照的干预性优效性临床试验，将评估基于附加呼气末二氧化碳监测的干预措施对老年患者缺氧发生率的影响。将 1800 例拟行异丙酚镇静下胃肠内镜检查的患者随机分配至对照组或干预组，分别实施标准或呼气末二氧化碳监测。
讨论
本研究主要旨在检验附加呼气末二氧化碳监测干预措施是否可减少老年患者在异丙酚和舒芬太尼镇静下进行胃肠内镜检查时缺氧的发生率。该研究的结果可能会广泛影响镇静下胃肠内镜检查和相关指南的制定。
试验注册
ClinicalTrials.gov NCT05030870。注册于 2021 年 9 月 1 日。
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