胃肠内镜中COMBO内镜口气道的有效性和安全性:多中心随机对照试验的研究方案
Yuhan Zhang1, Muyan Shi1, Yifeng Qu1
1Department of Anesthesiology, School of Medicine, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.
康博内镜口腔大气道在镇静性肠道内镜期间可以减少缺氧. 这种新的呼吸道管理技术旨在通过预防低氧症来提高患者的安全.
科学领域:
- 胃肠病学 胃肠病学
- 麻醉学 麻醉学
- 呼吸系统医学 呼吸系统医学
背景情况:
- 低氧是镇静性胃肠道 (GI) 内镜期间常见的不良事件,造成冠状动脉缺血和神经损伤等风险.
- 及时治疗缺氧是预防严重并发症和死亡的关键.
- 鼻口腔呼吸道内镜COMBO (镜监测咬伤阻断氧化) 是一种用于氧化和呼吸道管理的新设备.
研究的目的:
- 评估COMBO内镜口腔气道在镇静性肠道内镜期间预防缺氧的疗效和安全性.
- 为了比较使用COMBO气道的患者和接受常规鼻管的患者之间缺氧的发生率.
- 评估二次结果,包括亚临床和严重缺氧率和其他不良事件.
主要方法:
- 一个多中心的,随机的,开放的标签,优越性试验,涉及1200名患者,在普罗波镇静下接受肠道内镜检查.
- 18-60岁的参与者 (ASA等级I-II) 预期的手术时间≤45分钟被随机分配到传统的鼻腔管或COMBO气道组.
- 主要结果是缺氧的发生率 (定义为SpO2 75%-90% < 60秒).
主要成果:
- 这个部分不在所提供的摘要中.
结论:
- 康博内镜口气道代表了在镇静性肠道内镜期间氧化和气道管理的新方法.
- 这项研究旨在确定COMBO气道是否可以与标准护理相比显著降低缺氧发生率.
- 如果成功实施COMBO气道,这将是预防该患者群体低氧化血症的重大进展.
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