一个多组件的干预计划,以预防和减少激动和身体劳累在ICU (PRAISE):研究协议为一个多中心,阶梯,集群随机控制试验试验
Rens W J Kooken1, Bram Tilburgs2, Rob Ter Heine3
1Department of Intensive Care Medicine, Radboud university medical center, Nijmegen, The Netherlands. Rens.Kooken@radboudumc.nl.
本研究将多组分干预 (MCI) 进行比较,将非药物方法和轻度镇静与激动重症监护室 (ICU) 患者的身体限制相结合. 该MCI的目标是减少身体限制的使用,并改善患者的治疗结果.
科学领域:
- 关键护理医学 关键护理医学
- 患者安全 患者安全
- 临床试验设计 临床试验设计
背景情况:
- 对于激动的ICU患者来说,物理约束是常见的,尽管缺乏证据并造成伤害.
- 目前的限制最小化侧重于教育和非药物方法.
- 将干预措施与轻度镇静相结合,可能会进一步减少自制使用.
研究的目的:
- 为激动的ICU患者评估多组件干预 (MCI).
- 为了比较MCI (非药物 + 轻度镇静) 与物理限制.
- 评估减少ICU中物理限制使用的有效性.
主要方法:
- 多中心阶梯集群随机对照试验在6个荷兰ICU.
- 在26个月的时间里,有480名激动的成年患者,随访2年.
- 干预:MCI (教育,风险识别,护理计划,用德克塞米丁轻度镇静) 和标准护理.
主要成果:
- 主要结局:活着几天,28天内离开ICU.
- 二次结果:住院,生活质量,身体/精神/认知健康,成本效益.
- 过程评估将评估实施的忠实性.
结论:
- 第一个多中心RCT比较MCI (非药物 + 轻度镇静) 与激动的ICU患者的身体限制.
- 研究将提供对长期,以患者为中心的结果的见解.
- 结果将为ICU专业人员提供有关管理激动患者的信息.
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