输管选择镇静剂 (RSI) 随机试验的协议和统计分析计划
medRxiv : the preprint server for health sciences
|January 27, 2025
概括
与埃托米达相比,胺可能会降低紧急气管管道输入时的死亡率. 静脉注射 (RSI) 选择镇静剂的随机试验正在研究这一关键问题,对重症成人进行研究.
科学领域:
- 关键护理医学 关键护理医学
- 麻醉学 麻醉学
- 临床试验 临床试验
背景情况:
- 紧急气管输管是一种高风险的程序,基于选择镇静剂的不确定结果.
- 胺和埃托米达是用于紧急气管管道输液的常见诱导剂.
- 胺与埃托米达对患者死亡率的比较影响尚不清楚.
研究的目的:
- 为了确定胺与埃托米达相比,在接受紧急气管输管治疗的成年人中降低了28天住院死亡率.
- 评估输管过程中心血管崩的发生率作为次要结果.
主要方法:
- 静脉注射 (RSI) 选择镇静剂的随机试验是一种务实的,多中心的,未盲目的,并行组随机试验.
- 这项研究在14个美国地点招募了2,364名患重病的成年人接受紧急气管输管.
- 胺被比较与etomidate用于麻醉诱导.
主要成果:
- 这份手稿详细介绍了RSI试验的协议和统计分析计划.
- 主要结局是全因,28天住院死亡率.
- 二次结果包括心血管崩,由低血压,血管压缩剂使用和心脏骤停来定义.
结论:
- 该RSI试验将提供关于在紧急气道管理中选择镇静剂的关键数据.
- 预先指定协议和统计分析计划可以提高试验的严格性,可重现性和可解释性.
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