Ullman Amanda J, August Deanne, Kleidon Tricia, Walker Rachel, Marsh Nicole M, Bulmer Andrew, Pearch Benjamin, Runnegar Naomi, Schults Jessica A, Leema Joanne, Lee-Archer Paul, Biles Cathy, Southam Katrina, Gibson Victoria, Byrnes Joshua, Ware Robert S, Chopra Vineet, Coulthard Alan, Mollee Peter, Rickard Claire M, Harris Patrick N A
School of Nursing, Midwifery and Social Work, The University of Queensland, St Lucia, Queensland, Australia
Menzies Health Institute Queensland, Griffith University, Nathan, Queensland, Australia.
BMJ Open. 2021 Apr 14;11(4):e042475. doi: 10.1136/bmjopen-2020-042475.
Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications.
A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is , a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI.
Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published.
ACTRN12619000022167.
经外周静脉穿刺中心静脉导管（PICC）对于实施医学治疗至关重要，但高达30%的PICC会引发诸如深静脉血栓形成或感染等并发症。将抗菌和疏水导管材料以及压力激活阀整合到聚氨酯PICC中，是旨在预防感染性和/或血栓性并发症的创新举措。
一项多中心、平行组、优效性随机对照试验，设有两个试验组（(1) 疏水PICC（带压力激活阀）；(2) 葡萄糖酸氯己定浸渍PICC（带外部夹））和一个对照组（(3) 传统聚氨酯PICC（带外部夹））。将在澳大利亚昆士兰州的三家三级转诊医院，于2年时间内招募1098名成人和儿科患者。如果患者因医疗需要插入PICC，血管尺寸足以支撑4F或更大尺寸的PICC，且已获得知情同意，则符合纳入条件。主要结局是血栓形成（静脉血栓形成、破损和堵塞）和感染性并发症（PICC相关血流感染和局部感染）的综合情况。次要结局包括：全因PICC并发症；血栓形成并发症；感染性并发症；不良事件（局部或全身反应）；PICC留置时间；患者/家长满意度；以及医疗费用。将使用Cox比例风险回归比较两个干预组与对照组之间的差异。效应估计值将以风险比（HR）及相应的95%置信区间表示。
获得昆士兰卫生部门（HREC/QCHQ/48682）和格里菲斯大学（参考编号：2019/094）的伦理批准。研究结果将予以发表。
ACTRN12619000022167。
