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Peripheral intravascular cannula/catheter (PIVC) insertion is a common invasive procedure, but PIVC failure before the end of therapy is unacceptably high. As PIVC failure disrupts treatment and reinsertion can be distressing for the patient, prevention of PIVC failure is an important patient outcome. Consumer participation in PIVC care to prevent failure is an untapped resource. This study aimed to understand consumers' PIVC experience; establish aspects of PIVC insertion and care relevant to them; and to compare experiences of adult consumers to adult carers of a child. An international, web-based, cross-sectional survey was distributed via social media inviting adult consumers and adult carers of a child under 18 years who had experienced having a PIVC in the last five years (one survey each for adults and adult carers) to complete a 10-item survey. As such, sampling bias is a limitation and results should be carefully considered in light of this. There were 712 respondents from 25 countries, mainly female (87.1%) and adults (80%). A little over 50% of adults described insertion as moderately painful or worse, with level of insertion difficulty (0-10 scale) identified as moderate (median 4, IQR 1, 7). Adult carers reported significantly more pain during insertion and insertion difficulty (both p < 0.001). Rates of first insertion attempt failure were higher in children compared with adults (89/139 [64%] vs 221/554 [40%]; p < 0.001), and 23% of children required ≥ 4 attempts, compared with 9% of adults (p < 0.0001). Three themes from open-ended question emerged: Significance of safe and consistent PIVC care; Importance of staff training and competence; and Value of communication. The PIVC experience can be painful, stressful and frustrating for consumers. Priorities for clinicians and policy makers should include use of pain relief as standard practice to reduce the pain associated with PIVC insertion and developing strategies to increase first PIVC insertion attempt success particularly for children and older consumers.

Objective To develop and validate a difficult intravenous access risk assessment and escalation pathway, to increase first time intravenous insertion success in paediatrics. Methods Mixed methods underpinned by literature and co-production principles. Iterative development of the instrument was informed through semi-structured interviews and stakeholder workshops. The instrument includes a risk assessment, inserter skill self-assessment, and escalation pathways. Reproducibility, reliability, and acceptability were evaluated in a prospective cohort study at a quaternary paediatric hospital in Australia. Results Interview data (three parents, nine clinicians) uncovered two themes: i) Recognition of children with DIVA and subsequent escalation is ad hoc and problematic; and ii) Resources and training impact inserter confidence and ability. Three workshops were delivered at monthly intervals (February–April 2020) involving 21 stakeholders culminating in the co-production of the “DIVA Key”. The DIVA Key was evaluated between May–December 2020 in 78 children; 156 clinicians. Seventy-eight paired assessments were undertaken with substantial agreement (concordance range = 81.5 to 83.0%) between the assessors. Interrater reliability of the DIVA risk assessment was moderate (kappa = 0.71, 95% CI 0.63–0.80). The DIVA Key predicted multiple insertion attempts for red (high risk) DIVA classification (relative risk ratio 5.7, 95% CI 1.2–27.1; reference low risk). Consumer and clinician satisfaction with DIVA Key was high (median (IQR) = 10 [8–10]; 8 [8–10 respectively). Conclusion The DIVA Key is a straightforward, reliable instrument with inbuilt escalation pathway to support the identification of children with difficult intravenous access.

Background Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure. Methods An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined. Results Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5). Conclusions Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children. Trial registration ACTRN12614000280606 ; prospectively registered on 17/03/2014.

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.

Background To quantify the incidence of peripheral intravenous catheter (PIVC) infections and to describe the influence of clinical characteristics, including dwell time, on risk. Methods Meta-synthesis of 18 prospective studies (16 randomized controlled trials and two prospective cohort studies) reporting PIVC infections. In total, 14,606 PIVCs (50,096 device-days) were studied from insertion to removal in seven Australian government hospitals. PIVC care was provided by clinical staff with daily follow up by research nurses. We calculated incidences and rates of local infection (without bloodstream infection [BSI]) and PIVC-associated bloodstream infection (i.e., primary BSI) using the National Healthcare Safety Network criteria. The hazard function was assessed by fitting a parametric survival model. PIVC-associated BSI was further categorized as PIVC-related BSI and/or Staphylococcus aureus BSI. Case study methodology explored characteristics of PIVC-associated BSI, and life tables explored the hazard function of PIVC-associated BSI over dwell time. Results Of 14,606 PIVCs (dwell 0–42 days), there were five local infections (0.034%; 0.100/1,000 device-days) and six PIVC-associated BSI (0.041%; 0.120/1,000 device-days), of which four were PIVC-related and one was S. aureus BSI. PIVC-associated BSI involved Enterobacter cloacae ( n  = 3 including one co-infection with Citrobacter braakii ), Proteus mirabilis ( n  = 1), Pseudomonas aeruginosa ( n  = 1) and S. aureus ( n  = 1; S. aureus BSI incidence 0.007% catheters or 0.020/1000 device-days). PIVC-associated BSI cases commonly featured: males > 60 years with difficult intravenous access, delayed removal of idle or symptomatic PIVCs, cancer diagnoses, invasive gastrointestinal drains/procedures, insertion site complications, and forearm placement. PIVC-associated BSI daily hazard was constant over time with zero to 0.03% on Days 1 to 5 ( n  = 11,491), 0.06% to 0.10% on Days 6 and 7 ( n  = 2,571), and zero on Days 8 to 42 ( n  = 544). Conclusions Infection incidence is very low but remains a serious risk, mainly for complex patients. Gram-negative organisms may now be predominant in Australia. Infection surveillance should be risk-adjusted and prevention efforts to improve both insertion and post-insertion management targeted at high-risk groups. While overall intravenous therapy (exposure) should be minimised, daily risk per PIVC appears constant for at least 5 days.

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).

IntroductionPeripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications.Methods and analysisA multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure, a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI.Ethics and disseminationEthical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published.Trial registration numberACTRN12619000022167.

BackgroundHealthcare delivery is reliant on a functional central venous access device (CVAD), but the knowledge surrounding the burden of pediatric CVAD-associated harm is limited.MethodsA prospective cohort study at a tertiary-referral pediatric hospital in Australia. Children <18 years undergoing insertion of a CVAD were screened from the operating theatre and intensive care unit records, then assessed bi-weekly for up to 3 months. Outcomes were CVAD failure and complications, and associated healthcare costs (cost of complications).Results163 patients with 200 CVADs were recruited and followed for 6993 catheter days, with peripherally inserted central catheters most common (n = 119; 60%). CVAD failure occurred in 20% of devices (n = 30; 95% CI: 15–26), at an incidence rate (IR) of 5.72 per 1000 catheter days (95% CI: 4.09–7.78). CVAD complications were evident in 43% of all CVADs (n = 86; 95% CI: 36–50), at a rate of 12.29 per 1000 catheter days (95% CI: 9.84–15.16). CVAD failure costs were A $826 per episode, and A$ 165,372 per 1000 CVADs. Comparisons between current and recommended practice revealed inconsistent use of ultrasound guidance for insertion, sub-optimal tip-positioning, and appropriate device selection.ConclusionsCVAD complications and failures represent substantial burdens to children and healthcare. Future efforts need to focus on the inconsistent use of best practices.ImpactCurrent surveillance of central venous access device (CVAD) performance is likely under-estimating actual burden on pediatric patients and the healthcare system.CVAD failure due to complication was evident in 20% of CVADs. Costs associated with CVAD complications average at $2327 (AUD, 2020) per episode.Further investment in key diverse practice areas, including new CVAD types, CVAD pathology-based occlusion and dislodgment strategies, the appropriate use of device types, and tip-positioning technologies, will likely lead to extensive benefit.

Diaries summarizing intensive care are routine practice in some countries, although evidence to support diary use is limited. The purpose of this study was to identify whether distress post-intensive care influences patients' and relatives' choice as to whether they would like to receive a diary and what information delivery method is preferred. Intensive care patients admitted for at least 3 days and their relatives participated in an exploratory mixed methods study. Interviews were conducted 3 to 5 months after discharge. Psychological distress was assessed using Kessler-10 and Posttraumatic Stress Disorder Symptom Checklist − 5. Perceptions of benefit of diaries were assessed using a 4-point Likert scale. Differences were examined using Fisher exact test (P<.05). Fifty-seven patients and 22 relatives consented to participation, with 22 patients and 22 relatives interviewed before data saturation. Psychological distress was evident in 25 (47%) patients and 5 (23%) relatives. Participants' psychological health was similar for those who perceived diaries as beneficial, and those who did not. Themes included memory, process, and impact, although opinions were diverse. Patient and relative preferences of receiving a diary are not related to psychological distress. Diverse opinions around common themes suggest the need for a range of interventions to aid psychological recovery.

BackgroundData regarding vascular access device use and outcomes are limited. In part, this gap reflects the absence of guidance on what variables should be collected to assess patient outcomes. We sought to derive international consensus on a vascular access minimum dataset.MethodsA modified Delphi study with three rounds (two electronic surveys and a face-to-face consensus panel) was conducted involving international vascular access specialists. In Rounds 1 and 2, electronic surveys were distributed to healthcare professionals specialising in vascular access. Survey respondents were asked to rate the importance of variables, feasibility of data collection and acceptability of items, definitions and response options. In Round 3, a purposive expert panel met to review Round 1 and 2 ratings and reach consensus (defined as ≥70% agreement) on the final items to be included in a minimum dataset for vascular access devices.ResultsA total of 64 of 225 interdisciplinary healthcare professionals from 11 countries responded to Round 1 and 2 surveys (response rate of 34% and 29%, respectively). From the original 52 items, 50 items across five domains emerged from the Delphi procedure.Items related to demographic and clinical characteristics (n=5; eg, age), device characteristics (n=5; eg, device type), insertion (n=16; eg, indication), management (n=9; eg, dressing and securement), and complication and removal (n=15, eg, occlusion) were identified as requirements for a minimum dataset to track and evaluate vascular access device use and outcomes.ConclusionWe developed and internally validated a minimum dataset for vascular access device research. This study generated new knowledge to enable healthcare systems to collect relevant, useful and meaningful vascular access data. Use of this standardised approach can help benchmark clinical practice and target improvements worldwide.