高流量鼻氧 带或不带轮换头盔 非侵入性通风用于急性呼吸衰竭的氧化支持 (HONOUR):试点随机对照试验的协议
Federico Angriman1,2, Bruno L Ferreyro3,4, Bram Rochwerg5
1Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.
这项试点试验调查了与HFNO单独相比,在急性低氧性呼吸衰竭中,使用高流量鼻氧 (HFNO) 的头盔非侵入性通风是否可行. 结果将指导一项关于重症监护呼吸支的更大规模研究.
科学领域:
- 关键护理医学 关键护理医学
- 呼吸系统生理学 呼吸系统生理学
- 临床试验方法论 临床试验方法论
背景情况:
- 急性低氧性呼吸衰竭经常导致重症监护室 (ICU) 的入院.
- 非侵入性呼吸辅助,包括高流量鼻氧 (HFNO) 和头盔非侵入性通风,可能会降低对侵入性机械通风和死亡率的需求.
- 高流量鼻氧与或没有交替头盔的非侵入性通风为氧化支持急性呼吸衰竭 (HONOR) 试点试验旨在评估这些策略.
研究的目的:
- 在急性低氧性呼吸衰竭患者中,比较头盔非侵入性通风加HFNO与单独HFNO的可行性.
- 为了确定进行更大的随机对照试验的可行性.
主要方法:
- 一个务实的,开放的,多中心的随机控制试点试验,涉及200名加拿大12个加拿大ICU的急性低氧性呼吸衰竭的危急病人.
- 参与者被随机分配1:1接受头盔非侵入性通风加HFNO或单独HFNO至少48小时.
- 主要可行性结果包括招募率,协议遵守率和忠实于输管标准;次要结果包括输管率,死亡率,无呼吸器日,ICU停留时间和生活质量.
主要成果:
- 评估了可行性指标,如招聘率,协议遵守率和对输管标准的忠诚度.
- 评估了包括输管率,全因死亡率,无呼吸器日,ICU停留时间和6个月后的生活质量在内的次要结果.
- 贝叶斯方法用于分析初级和二级结果.
结论:
- 结果将为未来全面试验的可行性和设计提供信息.
- 结果将通过同行评审的出版物和会议演讲进行传播.
- 从所有参与的中心获得了道德认可.
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