术后的INTELLiVENT-适应性支持心脏手术患者的VEntilation (POSITiVE) 一个随机临床试验的II研究协议
Martin H Bernardi1, Dominique Bettex2, Laura A Buiteman-Kruizinga3,4
1Department of Anesthesia, General Intensive Care and Pain Management--Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. martin.bernardi@meduniwien.ac.at.
Trials
|July 3, 2024
概括
这项研究调查了与传统方法相比,INTELLiVENT适应性支持通风 (ASV) 是否可以改善心脏手术患者的通风质量. 结果将指导重症监护小组在手术后使用自动化通风.
科学领域:
- 关键护理医学 关键护理医学
- 呼吸系统疗法 呼吸系统疗法
- 麻醉学 麻醉学
背景情况:
- 之前的单中心试验表明,INTELLiVENT适应性支持通风 (ASV) 可以提高心脏手术后患者的通风质量.
- 自动通风模式,包括INTELLiVENT-ASV,已在各种重症患者群体中减少了人工呼吸器干预.
- 这项多中心研究专门评估INTELLiVENT-ASV在心脏手术后患者的疗效.
研究的目的:
- 测试INTELLiVENT-ASV在心脏手术后的患者中提供比传统通风更优质的通风质量的假设.
- 评估INTELLiVENT-ASV对重症监护室 (ICU) 团队工作人员工作量的影响.
- 评估以患者为中心的结果,例如机械呼吸的持续时间和ICU停留时间.
主要方法:
- 术后INTELLiVENT适应性支持心脏手术患者的VEntilationII (POSITiVEII) 试验是一项国际性的多中心随机优势试验.
- 328名接受选择性心脏手术并需要超过2小时的术后通风的成年患者被随机分组.
- 患者接受了INTELLiVENT-ASV或常规通风,主要终点是术后前两个小时内的通风质量.
主要成果:
- 主要终点,通风质量,是由时间在最佳,可接受和有害的通风参数范围内的比例定义的.
- 二级终点包括ICU团队员工的工作量,通过手动通风器设置和报警来衡量.
- 还评估了以患者为中心的结果,如通风持续时间和ICU停留时间.
结论:
- POSITiVE II是第一个国际性的多中心RCT,评估INTELLiVENT-ASV在心脏手术后患者的通风质量方面的优越性.
- 该试验旨在确认INTELLiVENT-ASV的好处,并评估其降低ICU工作人员工作负担的潜力.
- 研究结果将为关于在术后心脏手术护理中使用自动通风的临床决策提供信息.
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