胃肠内镜中与镇静相关的不良事件 (CH-ESC研究):在中国第三级医院进行前性观察队列研究的研究方案
Jun Lu1, Bo Li1, Shushu Yan1
1Faculty of Anesthesiology, Changhai Hospital, Naval Medical University, Shanghai, 200433, China.
Trials
|September 26, 2025
概括
这项研究调查了中国消化道内镜期间与镇静相关的不良事件. 它旨在识别风险因素,以提高这一群体的患者安全.
科学领域:
- 胃肠病学 胃肠病学
- 麻醉学 麻醉学
- 公共卫生 公共卫生
背景情况:
- 胃肠内镜 (GIE) 的镇静具有风险,特别是心肺复杂症.
- 关于镇静相关不良事件 (SRAE) 的现有研究主要来自西方国家,在中国人口中留下了数据缺口.
- 了解中国的SRAEs是至关重要的,因为在GIE中愈来愈多地使用镇静剂.
研究的目的:
- 评估中国患者中SRAE的患病率,特征和风险因素,这些患者接受了镇静剂GIE.
- 确定中国人口特有的SRAE预测因子.
- 为了有助于改善风险分层和患者安全协议的镇静性GIE.
主要方法:
- 在中国一家主要的三级医院进行了前性,观察性队列研究.
- 在2023年11月至2026年11月期间招募100,100名接受镇静性GIE的患者.
- 多变量后勤回归分析以确定SRAE的独立预测因子,使用人口统计,镇静和程序特征的数据.
主要成果:
- 截至2024年7月31日,自2023年12月1日以来,已有6023名参与者注册.
- 该研究正在进行中,计划将招生延长至2028年12月31日.
- 主要结果是GIE期间SRAE的发生率.
结论:
- 由于GIE的门诊和短期性质,准确报告SRAE可能具有挑战性.
- 这项研究是对中国SRAE的首次大规模调查.
- 结果可能会为加强风险分层模型和中国镇静性GIE患者的患者安全协议提供信息.
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