TY - JOUR
T1 - Securing All intraVenous devices Effectively in hospitalised patients-the SAVE trial
T2 - Study protocol for a multicentre randomised controlled trial
AU - Rickard, Claire M.
AU - Marsh, Nicole
AU - Webster, Joan
AU - Playford, E. Geoffrey
AU - McGrail, Matthew R.
AU - Larsen, Emily
AU - Keogh, Samantha
AU - McMillan, David
AU - Whitty, Jennifer A.
AU - Choudhury, Md Abu
AU - Dunster, Kimble R.
AU - Reynolds, Heather
AU - Marshall, Andrea
AU - Crilly, Julia
AU - Young, Jeanine
AU - Thom, Ogilvie
AU - Gowardman, John
AU - Corley, Amanda
AU - Fraser, John F.
PY - 2015
Y1 - 2015
N2 - 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 costeffectiveness 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.
AB - 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 costeffectiveness 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.
UR - http://www.scopus.com/inward/record.url?scp=84956955377&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2015-008689
DO - 10.1136/bmjopen-2015-008689
M3 - Article
C2 - 26399574
AN - SCOPUS:84956955377
SN - 2044-6055
VL - 5
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e008689
ER -