医院前临床试验相关程序对现场间隔,认知负载和错误的影响:随机模拟研究
Willem Stassen1, Craig Wylie1,2, Wesley Craig1
1Division of Emergency Medicine, University of Cape Town, Cape Town, South Africa.
Prehospital emergency care
|September 15, 2023
概括
涉及冷干燥血 (FDP) 和基于血红蛋白的氧载体 (HBOC) 的医院前随机对照试验在模拟环境中没有增加场景间隔,认知负载或医疗错误. 这表明试验程序可以安全地整合到紧急护理中.
科学领域:
- 紧急医疗 紧急医疗
- 临床试验 临床试验
- 在医院前的护理.
背景情况:
- 在全球范围内,医院前随机对照试验是罕见的.
- 缺乏经验可能导致协议偏差,间隔延长和错误,影响患者安全.
- 评估试验程序对医院前护理的影响至关重要.
研究的目的:
- 评估试验相关程序对模拟场景间隔,认知负载,医疗错误和行动时间的影响.
- 确定是否结合FDP和HBOC的管理影响了医院前护理的效率和安全.
主要方法:
- 具有交叉设计的前性模拟研究,涉及十个医院前临床医师团队.
- 三个模拟臂: (1) FDP + HBOC, (2) 仅 HBOC, (3) 标准护理,所有包括出血性休克管理.
- 测量场景间隔,错误率,认知负载 (NASA-TLX) 和能力 (SATLAB).
主要成果:
- 模拟组之间的场景间隔 (p=0.27),错误率 (p=0.28) 或认知负载 (p=0.67) 没有显著差异.
- 在认知负载和错误率 (r=0.15,p=0.42) 之间没有发现相关性.
- 所有参与者在所有模拟手臂中都获得了临床护理能力.
结论:
- 资格查和试验程序 (FDP,HBOC) 可以由医院前临床医生有效地执行,而不会增加现场时间.
- 模拟试验表明,试验程序可以安全地整合到医院前紧急护理中.
- 这种方法支持在医院前环境中谨慎执行临床试验.
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