血管内装置给药套件：住院患者标准使用与延长使用后的更换——一项随机对照试验的研究方案（RSVP试验）
Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients-a study protocol for a randomised controlled trial (The RSVP Trial).
作者信息
Rickard Claire M, Marsh Nicole M, Webster Joan, Gavin Nicole C, McGrail Matthew R, Larsen Emily, Corley Amanda, Long Debbie, Gowardman John R, Murgo Marghie, Fraser John F, Chan Raymond J, Wallis Marianne C, Young Jeanine, McMillan David, Zhang Li, Choudhury Md Abu, Graves Nicholas, Playford E Geoffrey
机构信息
NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Royal Brisbane and Women's Hospital, Brisbane, Australia Infection Management Services, Princess Alexandra Hospital, Brisbane, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Australia.
NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Royal Brisbane and Women's Hospital, Brisbane, Australia.
出版信息
BMJ Open. 2015 Feb 3;5(2):e007257. doi: 10.1136/bmjopen-2014-007257.
INTRODUCTION
Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3-4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload.
METHODS AND ANALYSIS
This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.
ETHICS AND DISSEMINATION
Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care.
TRIAL REGISTRATION NUMBER
Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).
引言
血管通路装置（VADs），如外周或中心静脉导管，在所有医学和外科专业中都至关重要。为了进行治疗或血流动力学监测，VADs通常需要由输液管路、液体容器、压力监测换能器和/或滴管组成的给药装置（AS）。虽然VADs仅在必要时更换，但AS通常每3 - 4天常规更换一次，因为人们认为这样可以减少感染并发症。有力证据支持AS使用长达4天，但对于AS使用超过4天的证据较少。每周更换两次AS会增加医院成本和工作量。
方法与分析
这是一项实用的、多中心、等效性设计的随机对照试验（RCT），比较4天（对照）与7天（试验）更换一次AS的情况。随机分组按部位和装置分层，由中心进行分配并保密直至入组。4年内将纳入6554例患有中心静脉导管、外周插入中心导管或外周动脉导管的成人/儿科患者。主要结局是VAD相关血流感染（BSI），次要结局是VAD定植、AS定植、全因BSI、全因死亡率、每位患者的AS数量、VAD在位时间和成本。每100个装置的VAD - BSI相对发病率和每1000装置日的风险率（95%置信区间）将总结7天与4天使用AS的影响并检验等效性。Kaplan - Meier生存曲线（采用对数秩Mantel - Cox检验）将比较不同时间的VAD - BSI。将使用适当的参数或非参数技术比较次要终点。p值<0.05将被视为具有统计学意义。
伦理与传播
已获得相关伦理批准。将使用CONSORT声明建议指导任何出版物的撰写。结果将在相关会议上公布，并发送给制定VAD护理临床实践指南的主要组织。
试验注册号
澳大利亚和新西兰临床试验注册中心（ACTRN 12610000505000）
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