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Aim: To test the feasibility of a study protocol that compared the efficacy of neutral‐ and negative‐pressure needleless connectors (NCs). Design: A single‐centre, parallel‐group, pilot randomised control trial. Methods: Our study compared neutral‐(intervention) and negative‐pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all‐cause peripheral intravenous catheter failure, analysed as time‐to‐event data. Results: In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All‐cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). Conclusion: With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. Implications for the Profession and/or Patient Care: There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high‐quality research is needed to explore NC design. Reporting Method: Study methods and results reported in adherence to the CONSORT Statement. Patient or Public Contribution: No patient or public contribution. [ABSTRACT FROM AUTHOR]

Background: Integrated peripheral intravenous catheters (PIVCs) demonstrate clinical efficacy, however, device complexity and design differences may be a potential barrier to implementation. Aims: To assess nurse acceptability of integrated PIVC systems. Methods: A cross-sectional survey was nested within a multicentre randomised controlled trial. One hundred nurses caring for patients with integrated and non-integrated PIVCs completed a 17-item survey about key differences between devices (eg function and appearance, perceived patient comfort and skin injuries). Findings: Most nurses reported the integrated PIVC wings prevented device movement (80%), achieved patient comfort in areas of flexion (78%), and no patients developed skin injuries (100%). Nurses rated the ease of accessing and overall confidence using the integrated PIVC as significantly higher than the non-integrated design (P<0.001).Conclusion: The integrated PIVC received positive feedback from nurses and had few barriers to implementation. [ABSTRACT FROM AUTHOR]

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Background: 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.Methods: 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.Findings: 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.Interpretation: 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.Funding: Australian National Health and Medical Research Council. [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 venous catheterisation is the most frequent invasive procedure performed in hospitalised patients; yet over 30% of peripheral venous catheters fail before treatment ends. Objectives To assess the effects of peripheral venous catheter dressings and securement devices on the incidence of peripheral venous catheter failure. Data sources We searched the Cochrane Wounds Group Register, The Cochrane Central Register of Controlled Trials, MEDLINE; EMBASE and CINAHL for any randomised controlled trials comparing different dressings or securement devices used to stabilise peripheral venous catheters. The reference lists of included studies were also searched for any previously unidentified studies. Results We included six randomised controlled trials (1539 participants) that compared various dressings and securement devices (transparent dressings versus gauze; bordered transparent dressings versus a securement device; bordered transparent dressings versus tape; and transparent dressing versus sticking plaster). Trial sizes ranged from 50 to 703 participants. The quality of evidence ranged from low to very low. Catheter dislodgements or accidental removals were lower with transparent dressings compared with gauze (two studies, 278 participants, risk ratio (RR) 0.40; 95% confidence interval (CI) 0.17–0.92, P = 0.03%). However, the relative effects of transparent dressings and gauze on phlebitis (RR 0.89; 95% CI 0.47–1.68) and infiltration (RR 0.80; 95% CI 0.48–1.33) are unclear. A single study identified less frequent dislodgement or accidental catheter removal with bordered transparent dressings compared to a securement device (RR 0.14, 95% CI 0.03–0.63) but more phlebitis with bordered dressings (RR 8.11, 95% CI 1.03–64.02). A comparison of a bordered transparent dressing and tape found more peripheral venous catheter failure with the bordered dressing (RR 1.84, 95% CI 1.08–3.11) but the relative effect on dislodgement was unclear. Conclusions There is no strong evidence to suggest that any one dressing or securement product for preventing peripheral venous catheter failure is more effective than any other product. All of the included trials were small, had high or unclear risk of bias for one or more of the quality elements we assessed, and wide confidence intervals, indicating that further randomised controlled trials are necessary. There is a need for suitably powered, high quality trials to evaluate the newer, high use products and novel – but expensive – securement methods, such as surgical grade glue. [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: 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]