Kleidon Tricia, Ullman Amanda J, Zhang Li, Mihala Gabor, Chaseling Brett, Schoutrop Jason, Rickard Claire M
Children's Health Queensland, Lady Cilento Children's Hospital, South Brisbane, Queensland, Australia.
Alliance for Vascular Access Teaching and Research Group, Menzies Health Institute Queensland, Nathan Campus, Queensland, Australia.
J Hosp Med. 2018 Aug 1;13(8):517-525. doi: 10.12788/jhm.2911. Epub 2018 Feb 8.
Despite the popularity of peripherally inserted central catheters (PICCs), recent literature highlights their potential injurious complications. Innovative PICC materials have been developed to prevent thrombosis and infection formation (Endexo®) and antireflux valves to prevent occlusion (pressure-activated safety valve®). No large randomized controlled trial has assessed these technologies. Our primary aim was to evaluate the feasibility of a large randomized controlled efficacy trial of PICC materials and design to reduce PICC complication in pediatrics.
A randomized controlled feasibility trial was undertaken at the Lady Cilento Children's Hospital in South Brisbane, Australia, between March 2016 and November 2016. Consecutive recruitment of 150 pediatric participants were randomly assigned to receive either (1) polyurethane PICC with a clamp or (2) BioFlo® PICC (AngioDynamics Inc, Queensbury, NY). Primary outcomes were trial feasibility, including PICC failure (thrombosis, occlusion, infection, breakage, or dislodgement). Secondary outcomes were PICC complications during use.
Protocol feasibility was established, including staff and patient acceptability, timely recruitment, no missing primary outcome data, and 0% attrition. PICC failure was 22% (16 of 74, standard care) and 11% (8 of 72, BioFlo®) corresponding to 12.6 and 7.3 failures per 1000 hours (risk ratio 0.58; 95% confidence interval, 0.21-1.43; P = .172). PICC failures were primarily due to thrombosis (standard care 7% versus BioFlo® 3%) and complete occlusion (standard care 7% versus BioFlo® 1%). No blood stream infections occurred. Significantly fewer patients with BioFlo® had PICC complications during use (15% vs 34%; P = .009).
BioFlo® PICCs appear potentially safer for pediatrics than traditional standard care PICCs with a clamp. Further research is required to definitively identify clinical, cost-effective methods to prevent PICC failure and improve reliability.
尽管外周静脉穿刺中心静脉导管（PICC）很常用，但近期文献强调了其潜在的有害并发症。已研发出创新的PICC材料以预防血栓形成和感染（Endexo®），以及防反流阀以预防堵塞（压力激活安全阀®）。尚无大型随机对照试验评估这些技术。我们的主要目的是评估一项关于PICC材料的大型随机对照疗效试验的可行性，并设计减少儿科PICC并发症的方案。
2016年3月至2016年11月期间，在澳大利亚布里斯班南部的西伦托夫人儿童医院进行了一项随机对照可行性试验。连续招募150名儿科参与者，随机分配接受以下两种情况之一：（1）带夹子的聚氨酯PICC，或（2）BioFlo® PICC（AngioDynamics公司，纽约州昆斯伯里）。主要结局是试验可行性，包括PICC失败（血栓形成、堵塞、感染）、断裂或移位。次要结局是使用期间的PICC并发症。
确定了方案的可行性，包括工作人员和患者的可接受性、及时招募、无主要结局数据缺失以及0%的损耗率。PICC失败率在标准护理组为22%（74例中的16例），在BioFlo®组为11%（72例中的8例），分别相当于每1000小时12.6次和7.3次失败（风险比0.58；95%置信区间，0.21 - 1.43；P = 0.172）。PICC失败主要归因于血栓形成（标准护理组7%对比BioFlo®组3%）和完全堵塞（标准护理组7%对比BioFlo®组1%）。未发生血流感染。使用期间BioFlo®组发生PICC并发症（15%对比34%；P = 0.009）的患者明显更少。
对于儿科患者，BioFlo® PICC似乎比带夹子的传统标准护理PICC更安全。需要进一步研究以明确确定预防PICC失败并提高可靠性的临床、具有成本效益的方法。
