澳大利亚儿童健康研究中心Amanda J. Ullman团队比较了三种外周置管中心导管材料的装置故障风险。该项研究成果发表在2025年1月9日出版的《新英格兰医学杂志》上。

用于经外周放置中心静脉导管（PICC）的新型导管材料可以降低因感染、血栓和导管闭塞事件导致的装置故障风险。然而，缺乏比较这些导管的随机试验数据。

研究组在三家澳大利亚三级医院进行了一项随机、对照、优势试验。被转诊进行PICC放置的成人和儿童以1:1:1的比例分配，接受疏水性或氯己定PICC或标准聚氨酯PICC，并随访8周。主要结局是装置故障，这是感染性（血流或局部）或非感染性（血栓形成、破裂或闭塞）并发症的复合表现。

共有1098名参与者接受了随机分组；365名分至疏水组，365名分至氯己定组，368名分至标准聚氨酯组。疏水组358名参与者中有21名（5.9%）发生装置故障，氯己定组363名参与者中有36名（9.9%），标准聚氨酯组359名参与者中有22名（6.1%）（疏水组与标准聚氨酯组的风险差异为-0.2个百分点[95%置信区间{CI}，-3.7至3.2；P=0.89]；氯己定组与标准聚氨酯组为3.8个百分点[95%CI，-0.1至7.8；P=0.06]）。

在疏水组中，与标准聚氨酯组相比，装置故障的优势比为0.96（95%CI，0.51至1.78），在氯己定组中，相较于标准聚氨酯组，优势比为1.71（95%CI：0.98至2.99）。在PICC置入期间，疏水性组有77名参与者（21.5%）出现全因并发症，氯己定组有140名参与者（38.6%），标准聚氨酯组有78名参与者（21.7%）（优势比：疏水性与标准聚氨酯，0.99[95%CI，0.69至1.42]；氯己定与标准聚氨酯，2.35[95%CI，1.68至3.29]）。干预措施未导致不良事件。

研究结果表明，在转诊进行PICC放置的成人和儿童中，疏水性或氯己定PICC因非感染性或感染性并发症导致的设备故障风险，并不低于标准聚氨酯PICC。

附：英文原文

Title: A Comparison of Peripherally Inserted Central Catheter Materials

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

Issue&Volume: 2025-01-09

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.

DOI: NJ202501093920211

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2406815