多中心随机试验的协议和统计分析计划 胺基与埃托米达特用于紧急气管管道输入
Stephanie C DeMasi1, Brant Imhoff1, Ariel A Lewis1
1From the Department of Emergency Medicine (S. C. D., G. W. W. V. S., A. J. L., W. H. S., and J. H. H.), the Department of Biostatistics (B. I. and L. W.), the Vanderbilt Institute for Clinical and Translational Research (A. A. L., B. D. L., T. L. I., T. W. R., W. H. S., J. D. C., and M. W. S.), the Division of Allergy, Pulmonary, and Critical Care Medicine (K.P. S., A. L. M., T. W. R., J. D. C., and M. W. S.), the Department of Pharmacy (K. C. S.), Vanderbilt University Medical Center, the Geriatric Research, Education, and Clinical Center (J. H. H.), Tennessee Valley Healthcare System, Nashville, TN; the Department of Emergency Medicine (B. E. D., M. E.P., A. E. R., and G. K. C.), the Division of Pulmonary, Allergy, and Critical Care Medicine (M. E.P. and G. K. C.), Department of Medicine, Hennepin County Medical Center, Minneapolis, MN; the Section of Pulmonary, Critical Care, Allergy and Immunologic Disease (K. W. G., J. A.P., and J. M. C.), Department of Medicine, the Department of Anesthesiology-Critical Care (J.P. G.), the Department of Emergency Medicine (J.P. G. and B. R.), Wake Forest School of Medicine, Winston-Salem, NC; the Department of Emergency Medicine (A. A. G., S. A. T., D. R.-A., and C. W.), the Department of Anesthesiology (L. J. S., J. C. B., and D. J. D.), University of Colorado School of Medicine; the Division of Pulmonary Sciences and Critical Care Medicine (N. R. A. and C. H.), Department of Medicine, University of Colorado Anschutz Medical Center, Aurora; the Department of Emergency Medicine (S. A. T. and C. L.), the Department of Anesthesiology (L. J. S.), Denver Health Medical Center (B. G.), Denver, CO; the Division of Pulmonary, Allergy and Critical Care Medicine (D. W. R., M. R. W., and S. G.), Department of Medicine, the Department of Emergency Medicine (M. R. W. and L. L. B.), University of Alabama at Birmingham, the Pulmonary Section (D. W. R.), Birmingham Veteran's Affairs Medical Center (J. M.), Birmingham, AL.
这项试验旨在调查胺与埃托米达相比,在紧急气管管道输液中是否能降低死亡率. 结果将为直管患者的重症监护镇静实践提供信息.
科学领域:
- 关键护理医学 关键护理医学
- 麻醉学 麻醉学
- 紧急医疗 紧急医疗
背景情况:
- 紧急气管输管是一种高风险的程序,诱导药物的效果不确定.
- 胺和埃托米达特是这个程序常用的镇静剂.
研究的目的:
- 为了确定胺是否与埃托米达相比,在接受紧急气管输管治疗的严重病情的成年人中降低了28天的死亡率.
- 评估输管期间心血管崩的发生率作为次要结果.
主要方法:
- 输管镇静剂选择随机试验 (RSI) 是一个务实的,多中心的,随机试验.
- 在2,364名患病危急的成年人中,比较胺与埃托米达特,这些成年人接受了紧急气管输管.
- 主要结局:所有原因的28天住院死亡率. 二次结局:心血管崩.
主要成果:
- 报名开始于2022年4月,预计将于2025年完成.
- 关于死亡率和心血管崩的数据正在等待最终结果.
结论:
- 该RSI试验将产生关于胺与埃托米达的关键数据,用于紧急气管管道输入.
- 协议和分析计划的透明度提高了试验的严谨性和可重复性.
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