Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial.

Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. Patients, clinicians, and research staff were not masked because of the nature of the intervention, but infections were adjudicated by a physician who was masked to treatment allocation. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 163 (38%) of 427 patients in the tissue adhesive with polyurethane group (absolute risk difference -4·5% [95% CI -11·1 to 2·1%], p=0·19), 169 (40%) of 423 of patients in the bordered polyurethane group (-2·7% [-9·3 to 3·9%] p=0·44), 176 (41%) of 425 patients in the securement device with poplyurethane group (-1·2% [-7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. Australian National Health and Medical Research Council.

Rickard CM ，Marsh N ，Webster J ，Runnegar N ，Larsen E ，McGrail MR ，Fullerton F ，Bettington E ，Whitty JA ，Choudhury MA ，Tuffaha H ，Corley A ，McMillan DJ ，Fraser JF ，Marshall AP ，Playford EG ... -  《-》

Novel technologies can provide effective dressing and securement for peripheral arterial catheters: A pilot randomised controlled trial in the operating theatre and the intensive care unit.

Peripheral arterial catheters are widely used in the care of intensive care patients for continuous blood pressure monitoring and blood sampling, yet failure - from dislodgement, accidental removal, and complications of phlebitis, pain, occlusion and infection - is common. While appropriate methods of dressing and securement are required to reduce these complications that cause failure, few studies have been conducted in this area. To determine initial effectiveness of one dressing and two securement methods versus usual care, in minimising failure in peripheral arterial catheters. Feasibility objectives were considered successful if 90/120 patients (75%) received the study intervention and protocol correctly, and had ease and satisfaction scores for the study dressing and securement devices of ≥ 7 on Numerical Rating Scale scores 1-10. In this single-site, four-arm, parallel, pilot randomised controlled trial, patients with arterial catheters, inserted in the operating theatre and admitted to the intensive care unit postoperatively, were randomly assigned to either one of the three treatment groups (bordered polyurethane dressing (n=30); a sutureless securement device (n=31); tissue adhesive (n=32)), or a control group (usual practice polyurethane dressing (not bordered) (n=30)). One hundred and twenty-three patients completed the trial. The primary outcome of catheter failure was 2/32 (6.3%) for tissue adhesive, 4/30 (13.3%) for bordered polyurethane, 5/31 (16.1%) for the sutureless securement device, and 6/30 (20%) for the control usual care polyurethane. Feasibility criteria were fulfilled. Cost analysis suggested that tissue adhesive was the most cost effective. The pilot trial showed that the novel technologies were at least as effective as the present method of a polyurethane dressing for dressing and securement of arterial catheters, and may be cost effective. The trial also provided evidence that a larger, multicentre trial would be feasible.

Reynolds H ，Taraporewalla K ，Tower M ，Mihala G ，Tuffaha HW ，Fraser JF ，Rickard CM ... -  《-》

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Charters B ，Foster K ，Lawton B ，Lee L ，Byrnes J ，Mihala G ，Cassidy C ，Schults J ，Kleidon TM ，McCaffery R ，Van K ，Funk V ，Ullman A ... -  《-》

Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial.

Chan RJ ，Northfield S ，Larsen E ，Mihala G ，Ullman A ，Hancock P ，Marsh N ，Gavin N ，Wyld D ，Allworth A ，Russell E ，Choudhury MA ，Flynn J ，Rickard CM ... -  《Trials》

Securing All intraVenous devices Effectively in hospitalised patients--the SAVE trial: study protocol for a multicentre randomised controlled trial.

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

Rickard CM ，Marsh N ，Webster J ，Playford EG ，McGrail MR ，Larsen E ，Keogh S ，McMillan D ，Whitty JA ，Choudhury MA ，Dunster KR ，Reynolds H ，Marshall A ，Crilly J ，Young J ，Thom O ，Gowardman J ，Corley A ，Fraser JF ... -  《BMJ Open》