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Abstract Objectives Arterial catheters (ACs) are critical for haemodynamic monitoring and blood sampling but are prone to complications. We investigated the incidence and risk factors of AC failure. Methods Secondary analysis of a multi-centre randomised controlled trial (ACTRN 12610000505000). Analysis included a subset of adult intensive care unit patients with an AC. The primary outcome was all-cause device failure. Secondary outcomes were catheter associated bloodstream infection (CABSI), suspected CABSI, occlusion, thrombosis, accidental removal, pain, and line fracture. Risk factors associated with AC failure were investigated using Cox proportional hazards and competing-risk models. Results Of 664 patients, 173 (26%) experienced AC failure (incidence rate [IR] 37/1000 catheter days). Suspected CABSI was the most common failure type (11%; IR 15.3/1000 catheter days), followed by occlusion (8%; IR 11.9/1,000 catheter days), and accidental removal (4%; IR 5.5/1000 catheter days). CABSI occurred in 16 (2%) patients. All-cause failure and occlusion were reduced with ultrasound-assisted insertion (failure: adjusted hazard ratio [HR] 0.43, 95% CI 0.25, 0.76; occlusion: sub-HR 0.11, 95% CI 0.03, 0.43). Increased age was associated with less AC failure (60–74 years HR 0.63, 95% CI 0.44 to 0.89; 75 + years HR 0.36, 95% CI 0.20, 0.64; referent 15–59 years). Females experienced more occlusion (adjusted sub-HR 2.53, 95% CI 1.49, 4.29), while patients with diabetes had less (SHR 0.15, 95% CI 0.04, 0.63). Suspected CABSI was associated with an abnormal insertion site appearance (SHR 2.71, 95% CI 1.48, 4.99). Conclusions AC failure is common with ultrasound-guided insertion associated with lower failure rates. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000); date registered: 18 June 2010.

Abstract Background Peripheral intravenous catheters (PIVCs) are essential for successful administration of intravenous treatments. However, insertion failure and PIVC complications are common and negatively impact patients’ health-outcomes and experiences. We aimed to assess whether generic (not condition-specific) quality of life and experience measures were suitable for assessing outcomes and experiences of patients with PIVCs. Methods We undertook a secondary analysis of data collected on three existing instruments within a large randomised controlled trial, conducted at two adult tertiary hospitals in Queensland, Australia. Instruments included the EuroQol Five Dimension - Five Level (EQ5D-5L), the Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – General measure (FACIT-TS-G, eight items), and the Australian Hospital Patient Experience Question Set (AHPEQS, 12 items). Responses were compared against two clinical PIVC outcomes of interest: all-cause failure and multiple insertion attempts. Classic descriptives were reported for ceiling and floor effects. Regression analyses examined validity (discrimination). Standardised response mean and effect size (ES) assessed responsiveness (EQ5D-5L, only). Results In total, 685 participants completed the EQ5D-5L at insertion and 526 at removal. The FACIT-TS-G was completed by 264 and the AHPEQS by 262 participants. Two FACIT-TS-G items and one AHPEQS item demonstrated ceiling effect. Instruments overall demonstrated poor discrimination, however, all-cause PIVC failure was significantly associated with several individual items in the instruments (e.g., AHPEQS, ‘unexpected physical and emotional harm’). EQ5D-5L demonstrated trivial (ES

Abstract Background Peripheral intravenous catheters (PIVCs) are the most used invasive medical device in healthcare. Yet around half of insertion attempts are unsuccessful leading to delayed medical treatments and patient discomfort of harm. Ultrasound-guided PIVC (USGPIVC) insertion is an evidence-based intervention shown to improve insertion success especially in patients with Difficult IntraVenous Access (BMC Health Serv Res 22:220, 2022), however the implementation in some healthcare settings remains suboptimal. This study aims to co-design interventions that optimise ultrasound guided PIVC insertion in patients with DIVA, implement and evaluate these initiatives and develop scale up activities. Methods A stepped-wedge cluster randomized controlled trial will be conducted in three hospitals (two adult, one paediatric) in Queensland, Australia. The intervention will be rolled out across 12 distinct clusters (four per hospital). Intervention development will be guided by Michie’s Behavior Change Wheel with the aim to increase local staff capability, opportunity, and motivation for appropriate, sustainable adoption of USGPIVC insertion. Eligible clusters include all wards or departments where > 10 PIVCs/week are typically inserted. All clusters will commence in the control (baseline) phase, then, one cluster per hospital will step up every two months, as feasible, to the implementation phase, where the intervention will be rolled out. Implementation strategies are tailored for each hospital by local investigators and advisory groups, through context assessments, staff surveys, and stakeholder interviews and informed by extensive consumer interviews and consultation. Outcome measures align with the RE-AIM framework including clinical-effectiveness outcomes (e.g., first-time PIVC insertion success for DIVA patients [primary outcome], number of insertion attempts); implementation outcomes (e.g., intervention fidelity, readiness assessment) and cost effectiveness outcomes. The Consolidated Framework for Implementation Research framework will be used to report the intervention as it was implemented; how people participated in and responded to the intervention; contextual influences and how the theory underpinning the intervention was realised and delivered at each site. A sustainability assessment will be undertaken at three- and six-months post intervention. Discussion Study findings will help define systematic solutions to implement DIVA identification and escalation tools aiming to address consumer dissatisfaction with current PIVC insertion practices. Such actionable knowledge is critical for implementation of scale-up activities. Trial registration Prospectively registered (Australian and New Zealand Clinical Trials Registry; ACTRN12621001497897).

Abstract 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 Background Unused ('idle') peripheral intravenous catheters (PIVC) are those not used within 24 hours of insertion. There is little data on cannulation practices and idle PIVC rates in emergency settings, especially the pre-hospital environment. Methods This was an observational cohort study set in south-east Queensland, Australia using data from a large tertiary level emergency department (ED) and the local statutory ambulance service. Demographic, clinical and PIVC data were collected over two periods; 9 February–18 March 2017 and 5 January–4 February 2018. Adult patients were included if they were allocated an Australasian triage scale (ATS) category between 2 and 5, and had a PIVC inserted in the pre-hospital setting or ED. PIVC use was defined as idle if no fluids, medications or contrast were administered intravenously within 24 hours of insertion. Comparisons between pre-hospital and ED practice and idle PIVC status were undertaken using descriptive statistics and logistic regression. Results A total of 1249 patients with a PIVC (372 pre-hospital; 877 ED) were included. Overall, 366 PIVCs (29.3%; 95% CI 26.9%–31.9%) remained idle at 24 hours. In the pre-hospital group, 147 (39.5%) PIVCs inserted were not used pre-hospital, and 74 (19.9%) remained idle. In comparison, 292 (33.3%) PIVCs placed in the ED remained idle. ED staff more frequently inserted PIVCs in the antecubital fossa than paramedics (65.5% vs. 49.7%), where forearm PIVC insertion was more common pre-hospital than in ED (13.7% vs. 7.4%). Nursing staff inserted idle PIVCs at a rate of (35.1%) compared to doctors (29.6%) and paramedics (19.9%). Having a PIVC inserted in the ED was the only factor significantly (p ≤ .001) predicting an idle outcome (Odds Ratio: 2.4; 95% CI 1.7–3.3). Conclusion One-third of PIVCs inserted within the emergency setting remained idle, suggesting unnecessary risk and costs. Pre-hospital and ED PIVC insertion practices differed, with idle PIVCs 2.4 times more prevalent if inserted in the ED than pre-hospital and with greater use of antecubital insertion. Reasons for these differences are not well understood and requires more targeted research.

Abstract 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 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 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.

Abstract 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.