Monash Newborn, Monash Children's Hospital, 246 Clayton Road, Clayton, Melbourne, VIC, 3168, Australia.
Hudson Institute of Medical Research, 246 Clayton Road, Clayton, Melbourne, VIC, 3168, Australia.
Eur J Pediatr. 2018 Nov;177(11):1719-1726. doi: 10.1007/s00431-018-3234-7. Epub 2018 Sep 6.
Peripheral intravenous cannula (PIVC) insertion is one of the most common invasive procedures performed in neonates and is frequently associated with adverse events. There are no studies in the neonatal population looking at the possibility of reducing the risk of PIVC-related complications by elective replacement of PIVC. A randomised, non-blinded, control trial was conducted in a tertiary level neonatal unit in Melbourne, Australia, to examine rates of extravasation in neonates with elective replacement of PIVC as compared to standard practice. Neonates born at 32 weeks of gestation or more were randomly assigned to have their PIVC replaced electively (every 72-96 h) or when clinically indicated in a 1:1 allocation ratio after parental consent. Primary outcome studied was rate of extravasation. Secondary outcomes included rates of phlebitis, leakage or spontaneous dislodgement of PIVC. One hundred thirteen infants were enrolled. Extravasation was noted in 33 (60%) of standard practice group vs. 28 (48.3%) of elective replacement (RR 0.80, CI 0.57-1.13, p = 0.21) infants. Time to first extravasation was similar between the groups (hazard ratio 0.69, CI 0.42-1.15). Extravasation events per 1000 IV hours were also similar between groups. Similar results were seen by both intention to treat and per protocol analyses. There was an increase in leaking rates (HR1.98, CI 1.03-3.81, p = 0.04) in the elective group, while phlebitis and spontaneous dislodgement rates were similar to standard group.Conclusion: Elective replacement of PIVC in neonates is not associated with reduction in extravasation rates.Trial registration: This trial has been registered with the Australian and New Zealand Clinical Trials Register. Identifier: ACTRN12615000827538. What is Known: • The reported incidence of extravasation injury is as high as 70% in the neonatal and paediatric population and has an association with cannula dwell time. • Adult studies have done to look at the possibility of reducing intravenous cannula-related complications with routine replacement of the cannulas but no similar studies have been done in the neonatal population. What is New: • Routine replacement of intravenous cannula in neonates between 72 and 96 h of use does not reduce the rate of extravasation injuries. • There might be some added complications associated with such a practice.
外周静脉置管 (PIVC) 插入是新生儿最常见的侵入性操作之一，常伴有不良事件。目前还没有研究关注通过选择性更换 PIVC 来降低与 PIVC 相关并发症的风险。本研究在澳大利亚墨尔本的一家三级新生儿病房进行了一项随机、非盲、对照试验，以检查在新生儿中选择性更换 PIVC 是否比标准实践更能降低外渗的发生率。胎龄 32 周或以上的新生儿在获得父母同意后，以 1:1 的比例随机分配到选择性更换 PIVC（每 72-96 小时）或根据临床指征更换 PIVC。主要研究结果是外渗发生率。次要结果包括静脉炎、渗漏或 PIVC 自发性脱落的发生率。共纳入 113 名婴儿。标准组外渗 33 例（60%），择期更换组 28 例（48.3%）（RR 0.80，CI 0.57-1.13，p=0.21）。两组首次外渗的时间相似（风险比 0.69，CI 0.42-1.15）。每 1000 小时静脉输液的外渗事件也相似。意向治疗和按方案分析均得出类似的结果。择期更换组漏液率升高（HR1.98，CI 1.03-3.81，p=0.04），而静脉炎和自发性脱落率与标准组相似。结论：新生儿选择性更换 PIVC 并不能降低外渗发生率。试验注册：本试验已在澳大利亚和新西兰临床试验注册中心注册。标识符：ACTRN12615000827538。已知：• 在新生儿和儿科人群中，外渗损伤的报告发生率高达 70%，且与导管留置时间有关。• 成人研究已经探讨了通过常规更换导管来降低与静脉导管相关的并发症的可能性，但在新生儿人群中尚未进行类似的研究。新发现：• 在新生儿使用静脉导管 72-96 小时之间进行常规更换不会降低外渗损伤的发生率。• 这种做法可能会带来一些额外的并发症。
