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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. [ABSTRACT FROM AUTHOR]

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 (< 1%) were lost to follow-up. In total, 792 PIV days were studied. PIV failure occurred in 43/150 BPU patients (29%) and 40/150 ISD patients (27%) (119 vs 93 per 1000 PIV days; incidence rate ratio 0.78, 95% confidence interval, CI 0.50-1.23). In the multivariate model, ISD (hazard ratio 0.51, 95% CI 0.29-0.89) and admission for a surgical emergency were significantly associated with decreased failure, while female gender, wound, hand insertion and more frequent PIV use were significantly associated with increased PIV failure.Conclusion: ISDs were significantly associated with decreased failure in the multivariable modelling. Feasibility outcomes were supportive of the need to undertake a larger trial to confirm these results.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12616000984493 . Registered 27 July 2016. [ABSTRACT FROM AUTHOR]

Background: Research has identified high failure rates of peripheral intravenous catheter (PIVC) and varied flushing practices.Methods: This is a single-centre, pilot, non-masked, factorial randomised controlled trial. Participants were adults, with a PIVC of expected use ≥24 hours (n = 160), admitted to general medical or surgical wards of a tertiary referral hospital in Queensland (Australia). Patients were randomly allocated to one of four flush groups using manually prepared syringes and 0.9 % sodium chloride: 10 mL or 3 mL flush, every 24 or 6 hours. The primary endpoint was PIVC failure, a composite measure of occlusion, infiltration, accidental dislodgement and phlebitis.Results: PIVC average dwell was 3.1 days. PIVC failure rates per 1000 hours were not significantly different for the volume intervention (4.84 [3 mL] versus 7.44 [10 mL], p = 0.06, log-rank). PIVC failure rates per 1000 hours were also not significantly different for the frequency intervention (5.06 [24 hour] versus 7.34 [6 hour], p = 0.05, log-rank). Cox proportional hazard regression found neither the flushing nor frequency intervention, or their interaction (p = 0.21) to be significantly associated with PIVC failure. However, female gender (hazard ratio [HR] 2.2 [1.3-3.6], p < 0.01), insertion in hand/posterior wrist (HR 1.7 [1.0-2.7], p < 0.05) and the rate per day of PIVC access (combined flushes and medication pushes) (HR 1.2 [1.1-1.4], p < 0.01) significantly predicted PIVC failure.Conclusion: Neither increased flushing volume nor frequency significantly altered the risk of PIVC failure. Female gender, hand/posterior wrist placement and episodes of access (flushes and medication) may be more important. Larger, definitive trials are feasible and required.Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12615000025538 . Registered on 19 January 2015. [ABSTRACT FROM AUTHOR]

Background: Peripherally inserted central catheters (PICCs) are commonly used for delivering intravenous therapy. PICC failure is unacceptably high (up to 40%) due to mechanical, infectious and thrombotic complications. Poor securement potentiates all complication types. This randomised controlled trial (RCT) aimed to examine the feasibility of a large RCT of four dressing and securement methods to prevent PICC failure.Methods: This single-centre pilot RCT included 124 admitted medical/surgical/cancer patients aged ≥ 16 years with a PICC. Interventions were: (i) standard polyurethane dressing and sutureless securement device (SPU + SSD, control); (ii) polyurethane with absorbent lattice pad dressing (PAL + Tape); (iii) combination securement-dressing (CSD); and (iv) tissue adhesive (TA + SPU). All groups except TA + SPU had a chlorhexidine-gluconate (CHG) impregnated disc. Feasibility outcomes were recruitment and safety/acceptability of the interventions. The primary outcome was PICC failure, a composite of PICC removal for local infection, catheter-associated bloodstream infection, dislodgement, occlusion, and/or catheter fracture. Secondary outcomes included individual complications, dressing failure and dwell time, PICC dwell time, skin complications/phlebitis indicators, product costs, and patient and staff satisfaction. Qualitative feedback was also collected.Results: PICC failure incidence was: PAL + CHG + Tape (1/5; 20%; 17.4/1000 days), SPU + SSD + CHG (control) (4/39; 10%; 9.0/1000 days), TA + SPU (3/35; 9%; 9.6/1000 days), and CSD + CHG (3/42; 7%; 9.4/1000 days). Recruitment to PAL + CHG + Tape was ceased after five participants due to concerns of PICC dislodgement when removing the dressing. CSD + CHG, TA + SPU (TA applied only at PICC insertion time), and control treatments were acceptable to patients and health professionals.Conclusion: A large RCT of CSD + CHG and TA + SPU (but not PAL + CHG + Tape) versus standard care is feasible.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12616000027415 . Registered on 15 January 2016. [ABSTRACT FROM AUTHOR]

Background: Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes.Methods: This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat.Results: Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference - 8%, 95% CI - 14 to - 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred.Conclusions: This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes.Trial Registration: Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415 . [ABSTRACT FROM AUTHOR]