在新生儿和儿童体外膜氧化过程中扫除氧化气 (NECTAR试验):单中心,试点随机对照试验
Adrian C Mattke1,2, Kerry Johnson1,2, Kristen Gibbons3
1Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.
概括
这项试点研究发现,将氧化输送到体外膜氧化 (ECMO) 电路中,对于重症儿童来说是安全和可行的. 在进行更大的试验之前,需要对氧化 (NO) 剂量和输送进行进一步的研究.
科学领域:
- 儿科重症监护医学 儿科重症监护医学
- 心肺支技术的心肺支技术
- 呼吸系统生理学 呼吸系统生理学
背景情况:
- 身体外膜氧化 (ECMO) 是对患有心肺衰竭的重症儿童的生命支持措施.
- 氧化 (NO) 是一种具有血管扩张性质的气体,在ECMO中可能有益.
- 在儿科患者中通过ECMO扫气 (sNO) 给NO的可行性和安全性需要研究.
研究的目的:
- 评估一项随机对照试验 (RCT) 的可行性和安全性,用于儿科ECMO的sNO输送.
- 探索sNO对接受ECMO的重症儿童临床结果的潜在影响.
主要方法:
- 一个前性的,单中心的,开放标签的试验RCT进行了.
- 需要静脉或静脉ECMO的重症儿童 (出生至16岁) 被随机分类.
- 干预组在扫除气中接受了sNO (20 ppm),对照组接受了标准扫除气.
主要成果:
- 60名符合条件的患者中有53名被随机分组;干预组的中位数年龄为1个月,对照组为6.2个月.
- 在30天和90天,没有ECMO和PICU的生存率在各组之间是相似的.
- 在血液产品的使用,循环持续时间,血血红蛋白,氧化器血栓或甲基红蛋白血症方面没有观察到显著差异;没有发生重大不良事件.
结论:
- 试验RCT表明,在儿科ECMO中进行sNO的试验是安全和可行的.
- 在这项研究中,没有发现sNO对临床结果的显著影响.
- 在进行更大规模的最终试验之前,建议进一步研究最佳的NO剂量和施用途径.
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