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腹腔内高血压比以前更少:一个试点阶段形试验
Shane Smith1,2,3, Fran Priestap3, Neil Parry1,2,3
1Office of Academic Military Medicine, Western University, London, Ontario, Canada.
概括
这项试点研究发现,在实施世界腹腔隔间综合征学会 (WSACS) 针对重症患者腹腔高血压 (IAH) 的指南时,患者招募和遵守率较低. 较大的试验不太可能检测出治疗效果,因为IAH发病率下降.
科学领域:
- 关键护理医学 关键护理医学
- 手术重症监护手术重症监护
- 临床试验设计 临床试验设计
背景情况:
- 腹腔内高血压 (IAH) 和腹腔综合征 (ACS) 是重症患者的严重疾病.
- 世界腹腔内腔综合症协会 (WSACS) 为管理IAH/ACS.提供了指导方针.
- 在多中心试验中实施这些指南的可行性需要评估.
研究的目的:
- 为了确定一个多中心阶段子集群随机试验的可行性,实施WSACS指南.
- 评估该干预措施对治疗危重病患者的IAH和ACS的影响.
主要方法:
- 使用单中心前后试验设计的试点研究.
- 观察期为3个月,然后在35个床位的医疗外科创伤ICU中进行9个月的干预期.
- 实施WSACS干预措施促使患者在干预期间被诊断出IAH.
主要成果:
- 招募了129名患者;IAH的发病率很低 (17.0%和12.9%).
- 观察到患者招募率低,协议遵守率差.
- 在ICU死亡率中,在队列之间或在IAH和没有IAH的患者之间没有发现显著差异.
结论:
- IAH的发病率有所下降,可能是由于日常护理的变化,影响了研究可行性.
- 较低的招聘和坚持,加上后勤压力,表明更大的多中心试验不太可能产生可检测的治疗效果.
- 进一步的研究可能需要考虑在重症患者群体中IAH管理的不断变化的格局.
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