Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)

Claire M Rickard; Nicole M Marsh; Joan Webster; Nicole C Gavin; Matthew R McGrail; Emily Larsen; Amanda Corley; Debbie Long; John R Gowardman; Marghie Murgo; John F Fraser; Raymond J Chan; Marianne C Wallis; Jeanine Young; David McMillan; Li Zhang; Md Abu Choudhury; Nicholas Graves; E Geoffrey Playford

doi:10.1136/bmjopen-2014-007257

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Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)

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Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)

Claire M Rickard, Nicole M Marsh, Joan Webster, Nicole C Gavin, Matthew R McGrail, Emily Larsen, Amanda Corley, Debbie Long, John R Gowardman, Marghie Murgo, …

BMJ Open, Vol.5(2), pp.e007257-e007257

02/2015

DOI: https://doi.org/10.1136/bmjopen-2014-007257

PMCID: PMC4322194

PMID: 25649214

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Abstract

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).

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Title: Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)
Creators: Claire M Rickard (Author) - Griffith University
Nicole M Marsh (Author) - Griffith University
Joan Webster (Author) - Griffith University
Nicole C Gavin (Author) - Griffith University
Matthew R McGrail (Author) - Monash University
Emily Larsen (Author) - Griffith University
Amanda Corley (Author) - Griffith University
Debbie Long (Author) - Griffith University
John R Gowardman (Author) - Griffith University
Marghie Murgo (Author) - Prince Charles Hospital
John F Fraser (Author) - Griffith University
Raymond J Chan (Author) - Griffith University
Marianne C Wallis (Author) - Griffith University
Jeanine Young (Author) - University of the Sunshine Coast
David McMillan (Author) - University of the Sunshine Coast
Li Zhang (Author) - Griffith University
Md Abu Choudhury (Author) - Griffith University
Nicholas Graves (Author) - Queensland University of Technology
E Geoffrey Playford (Author) - Griffith University
Publication Details: BMJ Open, Vol.5(2), pp.e007257-e007257
Publisher: B M J Group
Identifiers: 991012926995602368
Copyright: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Academic Unit: Nursing; Faculty of Health
Language: English
Resource Type: Journal article

Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)

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