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Abstract Background The reported incidence of peripheral intravenous catheter (PIV) failure has been as high as 69%. This is in part due to inadequate stabilisation or securement to the skin, which allows micro-motion of the catheter within the vein. Methods A pilot open randomised controlled trial of 300 patients was conducted in the medical and surgical wards of a large tertiary hospital. A superiority parallel pragmatic design was used. Eligible patients over the age of 16 years were randomised using a centralised service (randomly varied block sizes and 1:1 ratio) to have PIV dressings of either (i) a bordered polyurethane dressing (BPU, standard care) or (ii) the integrated securement device (ISD). Allocation was concealed until entry. The primary outcome of feasibility addressed eligibility, consent, protocol adherence and retention rates. All-cause PIV failure was an additional primary outcome. This was a composite of infection (laboratory-confirmed local or bloodstream infection), occlusion or infiltration, dislodgement, phlebitis and thrombosis. Group comparisons were by proportions, incidence rates per 1000 PIV days and hazard ratios. Secondary outcomes were local or bloodstream infection, occlusion or infiltration, dislodgement, phlebitis, thrombosis, PIV dwell time, safety and adverse events and patient satisfaction with study products. Analysis was by intention to treat and the patient was the unit of measurement. Multivariable modelling was undertaken. Results Feasibility outcomes were 91% of screened patients were eligible, 98% of invited patients consented, 100% of randomised participants received the allocated intervention on insertion and 1/300 (

Abstract Background Peripheral intravenous catheters (PVCs) are essential invasive devices, with 2 billion PVCs sold each year. The comparative efficacy of expert versus generalist inserter models for successful PVC insertion and subsequent reliable vascular access is unknown. Methods A single-centre, parallel-group, pilot randomised controlled trial (RCT) of 138 medical/surgical patients was conducted in a large tertiary hospital in Australia to compare PVC insertion by (1) a vascular access specialist (VAS) or (2) any nursing or medical clinician (generalist model). The primary outcome was the feasibility of a larger RCT as established by predetermined criteria (eligibility, recruitment, retention, protocol adherence). Secondary outcomes were PVC failure: phlebitis, infiltration/extravasation, occlusion, accidental removal or partial dislodgement, local infection or catheter-related bloodstream infection; dwell time; insertion success, insertion attempts; patient satisfaction; and procedural cost-effectiveness. Results Feasibility outcomes were achieved: 92% of screened patients were eligible; two patients refused participation; there was no attrition or missing outcome data. PVC failure was higher with generalists (27/50, 54%) than with VASs (33/69, 48%) (228 versus 217 per 1000 PVC days; incidence rate ratio 1.05, 95% confidence interval 0.61–1.80). There were no local or PVC-related infections in either group. All PVCs (n = 69) were successfully inserted in the VAS group. In the generalist group, 19 (28%) patients did not have a PVC inserted. There were inadequate data available for the cost-effectiveness analysis, but the mean insertion procedure time was 2 min in the VAS group and 11 min in the generalist group. Overall satisfaction with the PVC was measured on an 11-point scale (0 = not satisfied and 10 = satisfied) and was higher in the VAS group (n = 43; median = 7) compared to the generalist group (n = 20; median = 4.5). The multivariable model identified medical diagnosis and bed-bound status as being significantly associated with higher PVC failure, and securement with additional non-sterile tape was significantly associated with lower PVC failure. Conclusion This pilot trial confirmed the feasibility and need for a large, multicentre RCT to test these PVC insertion models. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616001675415. Registered on 6 December 2016.