中心静脉通路装置的固定与敷料效果：成人重症监护中的CASCADE初步随机对照试验

Central venous access device Securement and dressing effectiveness: The CASCADE pilot randomised controlled trial in the adult intensive care.

作者信息

Mitchell Marion L, Ullman Amanda J, Takashima Mari, Davis Chelsea, Mihala Gabor, Powell Madeleine, Gibson Victoria, Zhang Li, Bauer Michelle, Geoffrey Playford E, Rickard Claire M

机构信息

Alliance for Vascular Access Teaching and Research Group (AVATAR), Menzies Health Institute Queensland, Griffith University, Australia; School of Nursing and Midwifery, Griffith University, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.

出版信息

Aust Crit Care. 2020 Sep;33(5):441-451. doi: 10.1016/j.aucc.2019.10.002. Epub 2019 Nov 19.

DOI:10.1016/j.aucc.2019.10.002

PMID:31757717

Abstract

INTRODUCTION

Central venous access devices (CVADs) are a vital medical device for intensive care (ICU) patients; however, complications and failure are common, yet potentially prevented through effective dressings and securement.

OBJECTIVES/AIMS: The objective of this study was to test the feasibility of a randomised controlled trial (RCT) comparing standard care with three dressing and securement products to prevent CVAD failure. Secondary aims included comparing dressing and securement products on CVAD failure, microbial colonisation, and intervention costs.

METHODS

A single-centre pilot RCT of ICU adult patients requiring CVADs for >24 h were randomised to four groups: (i) sutures plus chlorhexidine gluconate (CHG) dressing (standard care); (ii) standard care plus tissue adhesive (TA); (iii) two sutureless stabilisation devices (SSD) plus CHG dressing; (iv) sutures, CHG disc plus integrated securement dressing (ISD). Descriptive statistics assessed feasibility. Incidence rates (IRs) of CVAD failure were reported, with group differences compared using the Fisher exact and log-rank tests. Cox regression explored univariable risks for failure. A substudy examined bacterial colonisation of catheter tips, dressings, and skin. Cost estimates of the intervention were compared.

RESULTS

A total of 121 participants were randomised. Study feasibility was established with no withdrawal and moderate staff acceptability; however, recruitment was low at 12%. Overall CVAD failure was seen in 14 of 114 (12%) CVADs (19 per 1000 catheter-days); highest in the SSD group (IR: 27.3 per 1000 catheter-days [95% confidence interval {CI}: 11.4-65.6]), followed by the standard care group (IR: 22.3 per 1000 catheter-days [95% CI: 8.38-59.5]) and TA group (IR: 20.6 per 1000 catheter-days [95% CI: 6.66-64.0]), and lowest in the ISD group (IR: 8.8 per 1000 catheter-days [95% CI: 2.19-35.0]). The majority of complications (11/14, 79%) were suspected central line-associated bloodstream infection (CLABSI), of which only one was laboratory confirmed (standard care group). The cost per patient was lowest in the standard care group by an average difference of AUD $14.

CONCLUSION(S): A large multisite RCT examining forms of securement and dressing is feasible. ISD is the highest priority to test further as it had the lowest failure rate.

TRIAL REGISTRATION

ACTRN12615000667516 PROTOCOL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 368765.

摘要

引言

中心静脉通路装置（CVADs）是重症监护（ICU）患者的重要医疗设备；然而，并发症和故障很常见，但通过有效的敷料和固定措施有可能预防。

目的

本研究的目的是测试一项随机对照试验（RCT）的可行性，该试验比较标准护理与三种敷料和固定产品以预防CVAD故障。次要目的包括比较敷料和固定产品对CVAD故障、微生物定植和干预成本的影响。

方法

对需要CVAD超过24小时的ICU成年患者进行单中心试点RCT，随机分为四组：（i）缝线加葡萄糖酸氯己定（CHG）敷料（标准护理）；（ii）标准护理加组织粘合剂（TA）；（iii）两种无缝线固定装置（SSD）加CHG敷料；（iv）缝线、CHG圆盘加集成固定敷料（ISD）。描述性统计评估可行性。报告CVAD故障的发生率（IRs），使用Fisher精确检验和对数秩检验比较组间差异。Cox回归探索失败的单变量风险。一项子研究检查了导管尖端、敷料和皮肤的细菌定植情况。比较了干预的成本估计。

结果

共有121名参与者被随机分组。确定了研究的可行性，无退出且工作人员接受度适中；然而，招募率较低，为12%。114个CVAD中有14个（12%）出现总体CVAD故障（每1000导管日19次）；SSD组最高（IR：每1000导管日27.3次[95%置信区间{CI}：11.4 - 65.6]），其次是标准护理组（IR：每1000导管日22.3次[95% CI：8.38 - 59.5]）和TA组（IR：每1000导管日20.6次[95% CI：6.66 - 64.0]），ISD组最低（IR：每1000导管日8.8次[95% CI：2.19 - 35.0]）。大多数并发症（11/14，79%）为疑似中心静脉导管相关血流感染（CLABSI），其中只有一例经实验室确诊（标准护理组）。标准护理组每位患者的成本最低，平均差异为14澳元。