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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: Central venous access devices (CVADs) can have high rates of failure due to dressing-related complications. CVADs placed in the internal jugular vein are at particular risk of dressing failure-related complications, including catheter-associated bloodstream infection and medical adhesive-related skin injury. Application of Mastisol liquid adhesive (MLA) may reduce CVAD dressing failure and associated complications, by reducing the frequency of dressing changes. The aim of this study is to investigate whether, in an intensive care unit (ICU) population, standard dressing care with or without the addition of MLA, improves internal jugular CVAD dressing adherence.Methods: This two-arm, parallel group randomised controlled trial will be conducted in three Australian ICUs. A total of 160 patients (80 per group) will be enrolled in accordance with study inclusion and exclusion criteria. Patients will be randomised to receive either (1) 'standard' (in accordance with local hospital policy) CVAD dressings (control) or (2) 'standard' dressings in addition to MLA (intervention). Patients will be followed from the time of CVAD insertion to 48 h after CVAD removal. The primary outcome is 'dressing failure' defined as requirement for initial CVAD dressing to be replaced prior to seven days (routine replacement).Discussion: This study will be the first randomised controlled trial to evaluate the clinical effectiveness of MLA in the adult intensive care unit population and will also provide crucial data for patient-important outcomes such as infection and skin injury.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001012864 . Registered on 2 August 2021. [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: To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC.Methods: This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time.Results: All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group.Conclusions: This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service.Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12616001578493 . Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15-21, 2017). [ABSTRACT FROM AUTHOR]