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ObjectiveTo determine the incidence of adverse events (AEs) associated with umbilical catheters in the neonatal population.Study designSystematic review and meta-analysis of observational studies and randomized controlled trials published between 2010 and 2020.ResultsIn total 14,226 umbilical venous catheters (UVCs) and 4228 umbilical arterial catheters (UACs) were included. Overall, 13.4% of UVCs were associated with an AE (95% CI: 10.1–17.0) or 2.4 per 1000 catheter days (95% CI: 1.8–3.0). UACs had an AE rate of 9% (95% CI: 5.9–12.8) or 0.87 per 1000 catheter days (95% CI: 0.4–1.3). UVC malposition was the most common (41.7% [95% CI: 27.6–56.5]). Local injury from UAC taping was the most common AE in one study.ConclusionsUmbilical catheters have a high incidence of AEs. Research into accurate methods of tip verification, tip surveillance, and securement is required.

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.

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 Our study aims to explore the experience of having a central venous access device (CVAD) from the perspective of the child and family and how movements within and outside of hospital environments influence this experience. Methods A mixed-methods study was conducted across Children’s Health Queensland (Australia), including inpatient and home-care settings. Children less than 18 years with CVADs were eligible and followed for 3 months or CVAD removal. A subgroup of primary caregivers participated in semi-structured interviews. Quantitative and qualitative measures of child and family CVAD experiences were explored. Results In total, 163 patients with 200 CVADs were recruited and followed for 6993 catheter days (3329 [48%] inpatients; 3147 [45%] outpatients; 517 [7%] home). Seventeen participants were interviewed. Experiences of having a CVAD were complex but predominantly positive primarily related to personalized CVAD care, healthcare quality, and general wellbeing. Their experience was shaped by their movements through hospital and home environments, including care variation and distress with procedures. Device selection and insertion location further influenced experience, including safety, impairments in activities of daily living, school, and recreation. Conclusions CVAD experiences were influenced by nonmodifiable (e.g., diagnosis) and modifiable factors (e.g., education; care variation). Clinical approaches and policies that account for family and child considerations should be explored. Impact Variation in decision making and management for pediatric CVADs is accepted by many clinicians, but the influence this variation has on the health experience of children and their families is less well explored. This is the first study to draw from a broad range of children requiring CVADs to determine their experience within and outside of healthcare facilities. Interdisciplinary clinicians and researchers need to work collaboratively with children and their families to provide resources and support services to ensure they have positive experiences with CVADs, no matter where they are managed, or who they are managed by.

New catheter materials for peripherally inserted central catheters (PICCs) may reduce the risk of device failure due to infectious, thrombotic, and catheter occlusion events. However, data from randomized trials comparing these catheters are lacking. We conducted a randomized, controlled, superiority trial in three Australian tertiary hospitals. Adults and children who were referred for PICC placement were assigned in a 1:1:1 ratio to receive a hydrophobic or chlorhexidine PICC or a standard polyurethane PICC and were followed for 8 weeks. The primary outcome was device failure, which was a composite of infectious (bloodstream or local) or noninfectious (thrombosis, breakage, or occlusion) complications. A total of 1098 participants underwent randomization; 365 were assigned to the hydrophobic group, 365 to the chlorhexidine group, and 368 to the standard-polyurethane group. Device failure occurred in 21 of 358 participants (5.9%) in the hydrophobic group, in 36 of 363 (9.9%) in the chlorhexidine group, and in 22 of 359 (6.1%) in the standard-polyurethane group (risk difference, hydrophobic vs. standard polyurethane, -0.2 percentage points [95% confidence interval {CI}, -3.7 to 3.2; P = 0.89]; and chlorhexidine vs. standard polyurethane, 3.8 percentage points [95% CI, -0.1 to 7.8; P = 0.06]). In the hydrophobic group as compared with the standard-polyurethane group, the odds ratio for device failure was 0.96 (95% CI, 0.51 to 1.78), and in the chlorhexidine group as compared with the standard-polyurethane group, the odds ratio was 1.71 (95% CI, 0.98 to 2.99). Complications from any cause during the period of PICC placement occurred in 77 participants (21.5%) in the hydrophobic group, in 140 (38.6%) in the chlorhexidine group, and in 78 (21.7%) in the standard-polyurethane group (odds ratio, hydrophobic vs. standard polyurethane, 0.99 [95% CI, 0.69 to 1.42]; and chlorhexidine vs. standard polyurethane, 2.35 [95% CI, 1.68 to 3.29]). No adverse events were attributable to the interventions. Among adults and children who were referred for PICC placement, the risk of device failure due to noninfectious or infectious complications was not lower with hydrophobic or chlorhexidine PICCs than with standard polyurethane PICCs. (Funded by the National Health and Medical Research Council of Australia; PICNIC Australian New Zealand Clinical Trials Registry number, ACTRN12619000022167.).

Neonates often require vascular access devices for medication or fluid therapy, but a third of devices fail before treatment completion or end with a complication. For adults and children, securing these devices with tissue adhesive (TA) increases the dwell and reduces complications. However, there is a lack of evidence for the neonatal population. This scoping review aimed to assess the evidence of TA for vascular access devices in neonates. The Arksey and O’Malley’s (2005) framework was used. The inclusion criteria covered studies published from 2007 (when TA was first reported for use in vascular access devices) to June 2024, available in English, Portuguese, and Spanish, across six databases. Two independent reviewers assessed the studies using Covidence software, with a third reviewer resolving conflicts. Quality assessment was performed using the Mixed Methods Appraisal Tool. From 981 identified studies, 12 were included. Most studies ( n  = 5, 41.7%) enrolled between 100 and 500 neonates with vascular access devices. Publications originated from four regions and were observational studies ( n  = 6, 50%), quasi-experimental ( n  = 3, 25%), and case series ( n  = 2, 16.7%) with one randomized controlled trial (8.3%) focusing on umbilical venous catheters (UVC). The most common TA composition used was a combination of n -butyl- and 2-octyl- cyanoacrylate ( n  = 4, 33.3%). The amount of TA applied varied across studies, and often TA was part of a bundle ( n  = 7, 58.3%). Most studies applied TA to central venous access devices ( n  = 10, 83.3%) and 2 (16.7%) in peripheral devices. Although there was variation in device failure, the studies generally indicated a reduction in complications such as dislodgment (central catheter: 11.3% [peripherally inserted central catheter {PICC}] to 24.6% [UVC] in non-TA group vs 0.7% [PICC] to 7.7% [UVC] in TA group), device-associated bloodstream infections (central: 7.7% [UVC] and incidence of 2.76/1000 catheter days [PICC] in non-TA group vs 3.1% [UVC] and incidence of 0.99/1000 catheter day [PICC] in TA group), and phlebitis (13% in non-TA group vs 3% in TA-group), as well as increased dwell time in peripheral catheters. Most studies included both term and preterm neonates but did not differentiate between them in their analyses. Skin assessment, life of first dressing, and follow-up of catheters and patients were not reported in most studies. Conclusion : TA may reduce complications in vascular access devices, but the evidence in neonates is limited and varied. Many studies include TA as part of bundle, making it difficult to isolate its effects. Additionally, the current evidence lacks robustness due to the design limitations of the studies. Future research should focus on randomized controlled trials to evaluate TA’s effectiveness and safety in preventing device failures and complications in neonates, considering different subgroups, to ensure the safety of TA in these nuanced populations. What is Known: • Research in adults and pediatrics provides evidence supporting the use of tissue adhesive (TA) for vascular access devices, showing a positive impact in reducing failures and complications. • The use of TA in neonates needs to be carefully considered due to their unique characteristics. What is New: • There is a gap in the literature on the use of TA for securing vascular access devices in neonates, particularly regarding its safety and effectiveness in preventing failures and complications. • Further studies are needed to provide robust evidence verifying the effectiveness and safety of TA in this population.

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).

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.

IntroductionPeripheral intravenous catheters (PIVCs) are the most commonly used vascular access device in hospitalised patients. Yet PIVCs may be complicated by local or systemic infections leading to increased healthcare costs. Chlorhexidine gluconate (CHG)-impregnated dressings may help reduce PIVC-related infectious complications but have not yet been evaluated. We hypothesise an impregnated CHG transparent dressing, in comparison to standard polyurethane dressing, will be safe, effective and cost-effective in protecting against PIVC-related infectious complications and phlebitis.Methods and analysisThe ProP trial is a multicentre, superiority, randomised clinical and cost-effectiveness trial with internal pilot, conducted across three centres in Australia and France. Patients (adults and children aged ≥6 years) requiring one PIVC for ≥48 hours are eligible. We will exclude patients with emergent PIVCs, known CHG allergy, skin injury at site of insertion or previous trial enrolment. Patients will be randomised to 3M Tegaderm Antimicrobial IV Advanced Securement dressing or standard care group. For the internal pilot, 300 patients will be enrolled to test protocol feasibility (eligibility, recruitment, retention, protocol fidelity, missing data and satisfaction of participants and staff), primary endpoint for internal pilot, assessed by independent data safety monitoring committee. Clinical outcomes will not be reviewed. Following feasibility assessment, the remaining 2624 (1312 per trial arm) patients will be enrolled following the same methods. The primary endpoint is a composite of catheter-related infectious complications and phlebitis. Recruitment began on 3 May 2023.Ethics and disseminationThe protocol was approved by Ouest I ethic committee in France and by The Queensland Children’s Hospital Human Research Ethics Committee in Australia. The findings will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration numberNCT05741866.

IntroductionPeripheral intravenous catheters (PIVCs) frequently fail during therapy administration, resulting in infusates pooling in the surrounding tissue. These extravasation injuries can cause significant pain, tissue destruction and scarring. ivWatch is a biosensor that uses visible and near-infrared light to measure tissue changes surrounding the PIVC and alert clinicians when extravasation may occur. The effectiveness of ivWatch, in comparison to clinical observation, in decreasing injury severity is unknown. The present study aims to investigate whether using ivWatch may potentially detect injury earlier and decrease the severity of PIVC extravasation injuries.Methods and analysisA single centre, parallel group, open-label superiority randomised controlled trial comparing (a) standard care (clinical observation) to (b) ivWatch monitoring in addition to standard care, to decrease the severity of extravasation injuries. 200 children with PIVCs inserted in the distal half of the limb, receiving intermediate-risk to high-risk infusates for ≥24 hours, will be consecutively recruited at a paediatric intensive care unit in Queensland, Australia. The primary outcome is extravasation severity, measured by the Cincinnati Children’s Extravasation Harm Scale. Secondary outcomes include severity assessed with three-dimensional camera imaging, extravasation volume, treatment sequelae, the number of PIVCs used and dwell time, quality of life and healthcare costs. The between treatment difference in extravasation severity will be compared using ordinal logistic regression, with the treatment group included as the main effect, and reported with corresponding 95% CIs. Estimates of value will be presented as net monetary benefits and cost per reduction in extravasation injury severity, both presented with corresponding 95% credible intervals.Ethics and disseminationThis study received approval from the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (reference number: HREC/20/QCHQ/60867) and the Griffith University HREC (reference number: 2020/310) and will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12620000317998.