title: Securing All intraVenous devices Effectively in hospitalised patients--the SAVE trial: study protocol for a multicentre randomised controlled trial.
abstract: BACKGROUND
  Over 70% of all hospital admissions have a peripheral intravenous device (PIV) inserted; however, the failure rate of PIVs is unacceptably high, with up to 69% of these devices failing before treatment is complete. Failure can be due to dislodgement, phlebitis, occlusion/infiltration and/or infection. This results in interrupted medical therapy; painful phlebitis and reinsertions; increased hospital length of stay, morbidity and mortality from infections; and wasted medical/nursing time. Appropriate PIV dressing and securement may prevent many cases of PIV failure, but little comparative data exist regarding the efficacy of various PIV dressing and securement methods. This trial will investigate the clinical and cost-effectiveness of 4 methods of PIV dressing and securement in preventing PIV failure.
  
  
  METHODS
  A multicentre, parallel group, superiority randomised controlled trial with 4 arms, 3 experimental groups (tissue adhesive, bordered polyurethane dressing, sutureless securement device) and 1 control (standard polyurethane dressing) is planned. There will be a 3-year recruitment of 1708 adult patients, with allocation concealment until randomisation by a centralised web-based service. The primary outcome is PIV failure which includes any of: dislodgement, occlusion/infiltration, phlebitis and infection. Secondary outcomes include: types of PIV failure, PIV dwell time, costs, device colonisation, skin colonisation, patient and staff satisfaction. Relative incidence rates of device failure per 100 devices and per 1000 device days with 95% CIs will summarise the impact of each dressing, and test differences between groups. Kaplan-Meier survival curves (with log-rank Mantel-Cox test) will compare device failure over time. p Values of <0.05 will be considered significant. Secondary end points will be compared between groups using parametric or non-parametric techniques appropriate to level of measurement.
  
  
  BACKGROUND
  Ethical approval has been received from Queensland Health (HREC/11/QRCH/152) and Griffith University (NRS/46/11/HREC). Results will be published according to the CONSORT statement and presented at relevant conferences.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trial Registry (ACTRN); 12611000769987.
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia Infection Management Services, Princess Alexandra Hospital, Brisbane, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Claire M
authors.initials: CM
authors.lastname: Rickard
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Nicole
authors.initials: N
authors.lastname: Marsh
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Joan
authors.initials: J
authors.lastname: Webster
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Infection Management Services, Princess Alexandra Hospital, Brisbane, Australia.
authors.forename: E Geoffrey
authors.initials: EG
authors.lastname: Playford
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia School of Rural Health, Monash University, Churchill, Victoria, Australia.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: McGrail
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Emily
authors.initials: E
authors.lastname: Larsen
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Samantha
authors.initials: S
authors.lastname: Keogh
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Inflammation and Healing Research Cluster, School of Health and Sport Sciences, University of the Sunshine Coast, Maroochydore, Queensland, Australia.
authors.forename: David
authors.initials: D
authors.lastname: McMillan
authors.affiliation: Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Whitty
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.
authors.forename: Md Abu
authors.initials: MA
authors.lastname: Choudhury
authors.affiliation: Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia Biomedical Engineering and Medical Physics, Science and Engineering Faculty, Queensland University of Technology, Brisbane, Queensland, Australia.
authors.forename: Kimble R
authors.initials: KR
authors.lastname: Dunster
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Heather
authors.initials: H
authors.lastname: Reynolds
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Gold Coast University Hospital, Gold Coast, Queensland, Australia.
authors.forename: Andrea
authors.initials: A
authors.lastname: Marshall
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Gold Coast University Hospital, Gold Coast, Queensland, Australia.
authors.forename: Julia
authors.initials: J
authors.lastname: Crilly
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia School of Nursing and Midwifery, University of the Sunshine Coast, Maroochydore, Queensland, Australia.
authors.forename: Jeanine
authors.initials: J
authors.lastname: Young
authors.affiliation: Nambour General Hospital, Nambour, Queensland, Australia Sunshine Coast Clinical School, The University of Queensland, Nambour, Queensland, Australia.
authors.forename: Ogilvie
authors.initials: O
authors.lastname: Thom
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Gowardman
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Corley
authors.affiliation: Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia.
authors.forename: John F
authors.initials: JF
authors.lastname: Fraser
mesh_terms: D000269:Adhesives; D061605:Administration, Intravenous; D000328:Adult; D001458:Bandages; D002406:Catheterization, Peripheral / Q000009:adverse effects; D002408:Catheters, Indwelling / Q000009:adverse effects; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003428:Cross Infection / Q000209:etiology; D004868:Equipment Failure; D006760:Hospitalization; D006801:Humans; D007262:Infusions, Intravenous; D010689:Phlebitis / Q000209:etiology; D011140:Polyurethanes; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000269:Adhesives; D011140:Polyurethanes
keywords: HEALTH ECONOMICS; MICROBIOLOGY