Lancet: 输液器更换间隔对导管相关血流感染的影响:随机-对照-等效-非劣势性试验

2021
05/04

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Lancet: 输液器更换间隔对导管相关血流感染的影响: 随机-对照-等效-非劣势性试验 分享智慧 共同成长 摘要 背景 目前尚不清楚用于预防威胁生命的导管相关血流感染(CRBSI)的最佳输液器更换时...

Lancet:

输液器更换间隔对导管相关血流感染的影响:

随机-对照-等效-非劣势性试验

 




 



分享智慧

共同成长


摘要

背景

目前尚不清楚用于预防威胁生命的导管相关血流感染(CRBSI)的最佳输液器更换时间。我们旨在比较7天(干预)和4天(对照组)输注套件更换以预防中央静脉通路装置(隧道式,非隧道式,外围插入式和完全植入式)和外周动脉导管患者发生CRBSI的有效性和成本。

方法

我们在澳大利亚的十家医院进行了一项随机,对照,评估者盲的试验。我们的假设是中央静脉通路设备的CRBSI等效性和外周动脉导管的非劣性(均为2%宽度)。通过集中的基于网络的服务(隐匿),将预期使用中央静脉通路设备超过24小时的成人和儿童–外周动脉导管的使用随机分配(1:1;按医院,导管类型,重症监护病房或病房分层,分组前隐)每7天或4天更换一次输液器。这包括晶体、非脂质肠胃外营养和药物输注。患者和临床医生没有被盲,但是主要结果(CRBSI)是由设盲的传染病医师裁定。使用修正的治疗意向分析进行数据处理(mITT)。

发现

在2011年5月30日至2016年12月9日之间,从6007名接受评估的患者中,我们为2944名患者分配了7天(n = 1463)或4天(n = 1481)输注套件更换,其中mITT分析为2941名。对于中心静脉通路设备,在1124例患者(7天组)中有20例(1.78%)和在1097例患者(4天组)中有16例(1·46%)患有CRBSI(绝对风险差异[ARD] 0· 32%,95%CI -0·73至1·37)。对于外周动脉导管,在7天组中357例患者中有1名(0·28%),在4天组中363例患者中没有CRBSI(ARD 0·28%,-0.27%至0·83 %)。没有与治疗有关的不良事件。

解释

输液器的使用可以安全地延长至7天,从而减少成本和工作量。

Abstract

Background

The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters.

Methods

We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device–peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete.

Findings

Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI −0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, −0·27% to 0·83%). There were no treatment-related adverse events.

Interpretation

Infusion set use can be safely extended to 7 days with resultant cost and workload reductions.




原文链接:

https://www.sciencedirect.com/science/article/abs/pii/S0140673621003512


THE

END


本文由作者自行上传,并且作者对本文图文涉及知识产权负全部责任。如有侵权请及时联系(邮箱:nanxingjun@hmkx.cn
关键词:
输液器,劣势性,ARD,导管,感染

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