一个随机的,受控的,可行性试验比较血管压缩剂输入通过外周管与中心静脉接入严重病情的成年人:VIPCA试验
Mahesh Ramanan1,2,3,4, Yogesh Apte1,5, Stacey Watts1
1Caboolture Hospital, Caboolture, Queensland, Australia.
概括
这项可行性研究发现,在重症患者中,早期中央静脉导管 (CVC) 插入的协议遵守率较低. 对于未来关于CVC时间和患者结果的最终试验,需要进行修改.
科学领域:
- 关键护理医学 关键护理医学
- 临床试验方法论 临床试验方法论
- 血管接入 血管接入
背景情况:
- 中枢静脉导管 (CVC) 插入时间对于重症患者至关重要.
- 早期插入CVC可能会带来好处,但需要进行可行性评估.
- 在等待CVC安置期间,使用外周静脉注射小管 (PIVC).
研究的目的:
- 评估最终随机试验的可行性,比较早期和晚期的CVC插入.
- 评估早期CVC插入是否会增加活着和出院的日数 (DAH-30).
- 检查协议的遵守,招募和数据完整性,用于未来的试验.
主要方法:
- 一个单一的中心,可行性随机对照试验.
- 用血管压缩剂治疗的危急病患者被随机分为1:1早期 (4小时内) 或晚期 (12小时后) 的CVC插入.
- 可行性结果包括协议遵守,招聘率和数据完整性.
主要成果:
- 招募了40名患者;每组20名患者.
- 早期的CVC组中 (55%) 与晚期的CVC组 (100%) 相比,协议遵守率明显较低.
- 中位数DAH-30在两组之间是相似的 (13.5 vs 19.0天),没有显著差异.
结论:
- 早期CVC组的协议遵守率较低,表明需要进行修改.
- 一个最终的试验需要调整协议以确保成功实施.
- 可行性受到坚持挑战的影响,需要为未来的研究进行改进.
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