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Securing All intraVenous devices Effectively in hospitalised patients—the SAVE trial: study protocol for a multicentre randomised controlled trial
  1. Claire M Rickard1,2,3,4,
  2. Nicole Marsh1,2,
  3. Joan Webster1,2,
  4. E Geoffrey Playford1,3,
  5. Matthew R McGrail1,5,
  6. Emily Larsen1,2,
  7. Samantha Keogh1,2,
  8. David McMillan1,6,
  9. Jennifer A Whitty7,
  10. Md Abu Choudhury1,
  11. Kimble R Dunster4,8,
  12. Heather Reynolds1,2,
  13. Andrea Marshall1,9,
  14. Julia Crilly1,9,
  15. Jeanine Young1,10,
  16. Ogilvie Thom11,12,
  17. John Gowardman1,2,
  18. Amanda Corley1,4,
  19. John F Fraser1,4
  1. 1Alliance for Vascular Access Teaching and Research, NHMRC Centre of Research Excellence in Nursing (NCREN), Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia
  2. 2Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
  3. 3Infection Management Services, Princess Alexandra Hospital, Brisbane, Australia
  4. 4Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia
  5. 5School of Rural Health, Monash University, Churchill, Victoria, Australia
  6. 6Inflammation and Healing Research Cluster, School of Health and Sport Sciences, University of the Sunshine Coast, Maroochydore, Queensland, Australia
  7. 7Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia
  8. 8Biomedical Engineering and Medical Physics, Science and Engineering Faculty, Queensland University of Technology, Brisbane, Queensland, Australia
  9. 9Gold Coast University Hospital, Gold Coast, Queensland, Australia
  10. 10School of Nursing and Midwifery, University of the Sunshine Coast, Maroochydore, Queensland, Australia
  11. 11Nambour General Hospital, Nambour, Queensland, Australia
  12. 12Sunshine Coast Clinical School, The University of Queensland, Nambour, Queensland, Australia
  1. Correspondence to Professor Claire M Rickard; c.rickard{at}griffith.edu.au

Abstract

Introduction 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 and analysis 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.

Ethics and dissemination 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.

Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN); 12611000769987.

  • HEALTH ECONOMICS
  • MICROBIOLOGY

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 non-commercially, 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/

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