外周静脉穿刺中心静脉导管材料的比较

A Comparison of Peripherally Inserted Central Catheter Materials.

作者信息

Ullman Amanda J, August Deanne, Kleidon Tricia M, Walker Rachel M, Marsh Nicole, Bulmer Andrew C, Pearch Ben, Runnegar Naomi, Leema Joanne, Lee-Archer Paul, Biles Cathy, Gibson Victoria, Royle Ruth, Southam Katrina, Byrnes Joshua, Chopra Vineet, Coulthard Alan, Mollee Peter, Rickard Claire M, Harris Patrick N A, Ware Robert S

机构信息

From the University of Queensland, Brisbane, QLD, Australia (A.J.U., D.A., T.M.K., N.M., N.R., P.L.-A., V.G., A.C., P.M., C.M.R., P.N.A.H.); Children's Health Queensland Hospital and Health Service, Brisbane, QLD, Australia (A.J.U., T.M.K., P.L.-A., V.G.); Griffith University, Brisbane, QLD, Australia (A.J.U., D.A., T.M.K., R.M.W., N.M., A.C.B., R.R., J.B., V.C., C.M.R., R.S.W.); Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia (A.J.U., T.M.K., N.M., K.S., A.C., P.N.A.H.); Princess Alexandra Hospital, Brisbane, QLD, Australia (R.M.W., B.P., N.R., J.L., C.B., P.M.); University of Colorado, Denver (V.C.); and Metro North Health, Brisbane, QLD, Australia (C.M.R.).

出版信息

N Engl J Med. 2025 Jan 9;392(2):161-172. doi: 10.1056/NEJMoa2406815.

DOI:10.1056/NEJMoa2406815

PMID:39778170

Abstract

BACKGROUND

New catheter materials for peripherally inserted central catheters (PICCs) may reduce the risk of device failure due to infectious, thrombotic, and catheter occlusion events. However, data from randomized trials comparing these catheters are lacking.

METHODS

We conducted a randomized, controlled, superiority trial in three Australian tertiary hospitals. Adults and children who were referred for PICC placement were assigned in a 1:1:1 ratio to receive a hydrophobic or chlorhexidine PICC or a standard polyurethane PICC and were followed for 8 weeks. The primary outcome was device failure, which was a composite of infectious (bloodstream or local) or noninfectious (thrombosis, breakage, or occlusion) complications.

RESULTS

A total of 1098 participants underwent randomization; 365 were assigned to the hydrophobic group, 365 to the chlorhexidine group, and 368 to the standard-polyurethane group. Device failure occurred in 21 of 358 participants (5.9%) in the hydrophobic group, in 36 of 363 (9.9%) in the chlorhexidine group, and in 22 of 359 (6.1%) in the standard-polyurethane group (risk difference, hydrophobic vs. standard polyurethane, -0.2 percentage points [95% confidence interval {CI}, -3.7 to 3.2; P = 0.89]; and chlorhexidine vs. standard polyurethane, 3.8 percentage points [95% CI, -0.1 to 7.8; P = 0.06]). In the hydrophobic group as compared with the standard-polyurethane group, the odds ratio for device failure was 0.96 (95% CI, 0.51 to 1.78), and in the chlorhexidine group as compared with the standard-polyurethane group, the odds ratio was 1.71 (95% CI, 0.98 to 2.99). Complications from any cause during the period of PICC placement occurred in 77 participants (21.5%) in the hydrophobic group, in 140 (38.6%) in the chlorhexidine group, and in 78 (21.7%) in the standard-polyurethane group (odds ratio, hydrophobic vs. standard polyurethane, 0.99 [95% CI, 0.69 to 1.42]; and chlorhexidine vs. standard polyurethane, 2.35 [95% CI, 1.68 to 3.29]). No adverse events were attributable to the interventions.

CONCLUSIONS

Among adults and children who were referred for PICC placement, the risk of device failure due to noninfectious or infectious complications was not lower with hydrophobic or chlorhexidine PICCs than with standard polyurethane PICCs. (Funded by the National Health and Medical Research Council of Australia; PICNIC Australian New Zealand Clinical Trials Registry number, ACTRN12619000022167.).

摘要

背景

用于外周静脉穿刺中心静脉导管（PICC）的新型导管材料可能会降低因感染、血栓形成和导管堵塞事件导致的器械故障风险。然而，缺乏比较这些导管的随机试验数据。

方法

我们在澳大利亚的三家三级医院进行了一项随机对照优效性试验。被转诊进行PICC置管的成人和儿童按1:1:1的比例分配，分别接受疏水型或洗必泰PICC或标准聚氨酯PICC，并随访8周。主要结局是器械故障，其为感染性（血流感染或局部感染）或非感染性（血栓形成、破损或堵塞）并发症的综合结果。

结果

共有1098名参与者进行了随机分组；365人被分配到疏水型组，365人被分配到洗必泰组，368人被分配到标准聚氨酯组。疏水型组358名参与者中有21人（5.9%）发生器械故障，洗必泰组363名中有36人（9.9%），标准聚氨酯组359名中有22人（6.1%）（风险差异，疏水型与标准聚氨酯相比，-0.2个百分点[95%置信区间{CI}，-3.7至3.2；P = 0.89]；洗必泰与标准聚氨酯相比，3.8个百分点[95% CI，-0.1至7.8；P = 0.06]）。与标准聚氨酯组相比，疏水型组器械故障的比值比为0.96（95% CI，0.51至1.78），洗必泰组与标准聚氨酯组相比，比值比为1.71（95% CI，0.98至2.99）。在PICC置管期间，疏水型组77名参与者（21.5%）发生任何原因的并发症，洗必泰组140名（38.6%），标准聚氨酯组78名（21.7%）（比值比，疏水型与标准聚氨酯相比，0.99[95% CI，0.69至1.42]；洗必泰与标准聚氨酯相比，2.35[95% CI，1.68至3.29]）。没有不良事件可归因于干预措施。