成人急性医院患者外周静脉置入中心静脉导管的中心静脉通路装置固定与敷料有效性研究（CASCADE）：一项试点随机对照试验
Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial.
作者信息
Chan Raymond J, Northfield Sarah, Larsen Emily, Mihala Gabor, Ullman Amanda, Hancock Peter, Marsh Nicole, Gavin Nicole, Wyld David, Allworth Anthony, Russell Emily, Choudhury Md Abu, Flynn Julie, Rickard Claire M
机构信息
Royal Brisbane and Women's Hospital, Metro North Hospital and Health Service, Butterfield Street, Herston, Brisbane, Queensland, 4029, Australia.
School of Nursing and Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Brisbane, Queensland, 4059, Australia.
出版信息
Trials. 2017 Oct 4;18(1):458. doi: 10.1186/s13063-017-2207-x.
BACKGROUND
Peripherally inserted central catheters (PICCs) are commonly used for delivering intravenous therapy. PICC failure is unacceptably high (up to 40%) due to mechanical, infectious and thrombotic complications. Poor securement potentiates all complication types. This randomised controlled trial (RCT) aimed to examine the feasibility of a large RCT of four dressing and securement methods to prevent PICC failure.
METHODS
This single-centre pilot RCT included 124 admitted medical/surgical/cancer patients aged ≥ 16 years with a PICC. Interventions were: (i) standard polyurethane dressing and sutureless securement device (SPU + SSD, control); (ii) polyurethane with absorbent lattice pad dressing (PAL + Tape); (iii) combination securement-dressing (CSD); and (iv) tissue adhesive (TA + SPU). All groups except TA + SPU had a chlorhexidine-gluconate (CHG) impregnated disc. Feasibility outcomes were recruitment and safety/acceptability of the interventions. The primary outcome was PICC failure, a composite of PICC removal for local infection, catheter-associated bloodstream infection, dislodgement, occlusion, and/or catheter fracture. Secondary outcomes included individual complications, dressing failure and dwell time, PICC dwell time, skin complications/phlebitis indicators, product costs, and patient and staff satisfaction. Qualitative feedback was also collected.
RESULTS
PICC failure incidence was: PAL + CHG + Tape (1/5; 20%; 17.4/1000 days), SPU + SSD + CHG (control) (4/39; 10%; 9.0/1000 days), TA + SPU (3/35; 9%; 9.6/1000 days), and CSD + CHG (3/42; 7%; 9.4/1000 days). Recruitment to PAL + CHG + Tape was ceased after five participants due to concerns of PICC dislodgement when removing the dressing. CSD + CHG, TA + SPU (TA applied only at PICC insertion time), and control treatments were acceptable to patients and health professionals.
CONCLUSION
A large RCT of CSD + CHG and TA + SPU (but not PAL + CHG + Tape) versus standard care is feasible.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry, ACTRN12616000027415 . Registered on 15 January 2016.
背景
外周静脉穿刺中心静脉导管（PICC）常用于进行静脉治疗。由于机械性、感染性和血栓性并发症，PICC失败率高得令人难以接受（高达40%）。固定不佳会增加所有类型并发症的发生风险。这项随机对照试验（RCT）旨在检验一项大型RCT的可行性，该大型RCT将比较四种敷料和固定方法预防PICC失败的效果。
方法
这项单中心试点RCT纳入了124例年龄≥16岁、接受PICC的内科/外科/癌症住院患者。干预措施包括：（i）标准聚氨酯敷料和无缝合固定装置（SPU + SSD，对照组）；（ii）带有吸收性网格垫的聚氨酯敷料（PAL + 胶带）；（iii）联合固定 - 敷料（CSD）；（iv）组织粘合剂（TA + SPU）。除TA + SPU组外，所有组均有含葡萄糖酸氯己定（CHG）的圆盘。可行性指标为招募情况以及干预措施的安全性/可接受性。主要结局是PICC失败，定义为因局部感染、导管相关血流感染、移位、堵塞和/或导管断裂而拔除PICC的综合情况。次要结局包括个体并发症、敷料失败和留置时间、PICC留置时间、皮肤并发症/静脉炎指标、产品成本以及患者和工作人员满意度。还收集了定性反馈。
结果
PICC失败发生率分别为：PAL + CHG + 胶带组（1/5；20%；17.4/1000天），SPU + SSD + CHG（对照组）（4/39；10%；9.0/1000天），TA + SPU组（3/35；9%；9.6/1000天），以及CSD + CHG组（3/42；7%；9.4/1000天）。由于担心移除敷料时PICC移位，在纳入5名参与者后停止了PAL + CHG + 胶带组的招募。CSD + CHG组、TA + SPU组（TA仅在PICC插入时应用）和对照治疗对患者和医护人员来说是可接受的。
结论
对CSD + CHG组和TA + SPU组（而非PAL + CHG + 胶带组）与标准护理进行大型RCT是可行的。
试验注册
澳大利亚和新西兰临床试验注册中心，ACTRN12616000027415。于2016年1月15日注册。
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