Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

An mHealth application for chronic vascular access: Consumer led co-creation.

PURPOSE: Children with chronic and complex health conditions frequently need intravenous devices. The current approach to intravenous device selection, insertion, and monitoring is inconsistent, and healthcare consumers are often negatively affected by siloed health information, and poor future planning. Despite child- and family-centred care being recognised as a pillar of paediatric nursing care, limited implementation for vascular access device planning and management is evident. DESIGN AND METHODS: To address this, we conducted a multi-phased approach to co-create, then evaluate, a mobile health (mHealth) application: IV Passport. Co-creation involved a prioritisation survey, followed by a Passport advisory panel consensus meeting. Following confirmation of the required content and features of the Passport, the mHealth application was designed and content validation achieved via survey. RESULTS: The prioritisation survey yielded recommendations for seven features (e.g., graphical presentations of current/past devices). Content for nine device types (e.g., totally implanted ports) was suggested, each with 10 related items (e.g., insertion site). Content items for device-associated complications, future vascular access plans, and educational resources were also suggested. Following design, the application was released through Apple and Android platforms; and adapted to a paper version. Content validation was established; 100% strongly agreed the application was easy to use; 80% agreed/strongly agreed that they would recommend the Passport to others. CONCLUSION: IV Passport embodies effective child- and family-centred care through consumer co-creation to empower patients and families manage vascular access devices. PRACTICE IMPLICATIONS: IV Passport remains active; and can be utilised across many healthcare settings and patient populations.

An mHealth application for chronic vascular access: A multi-method evaluation.

BACKGROUND: Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose. AIM: In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport. DESIGN: Multi-site, parallel, multi-method, prospective cohort study. METHODS: A multi-site, multi-method study was carried out in 2020-2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months. RESULTS: Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5-10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality. CONCLUSION: Several recommendations were made to improve the end-user experience including 'how to' instructions; and scheduling functionality for routine care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The IV Passport can be safely and appropriately integrated into healthcare, to support consumers. IMPACT: Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians. REPORTING METHOD: Not applicable. PATIENT CONTRIBUTION: Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

Midline Compared With Peripheral Intravenous Catheters for Therapy of 4 Days or Longer in Pediatric Patients: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) frequently fail during treatment causing therapy interruption, pain, recatheterization, and additional health care costs. Midline catheters (MCs) may improve functional dwell time and reduce failure compared with traditional PIVCs. Objective: To compare device failure of MCs with PIVCs. Design, Setting, and Participants: This was a pragmatic, randomized clinical superiority trial with an embedded internal pilot study conducted from July 2020 to May 2022. The study took place in a quaternary pediatric hospital in Brisbane, Queensland, Australia. Inclusion criteria were patients aged 1 to 18 years requiring peripherally compatible intravenous therapy for 4 days or longer. Interventions: Patients were randomly assigned 1:1 to receive a PIVC or MC, stratified by age (≤5 years, >5 years). One catheter was studied per patient. Main Outcomes and Measures: The primary outcome was all-cause device failure, defined as premature cessation of device function. Secondary outcomes included number of insertion attempts, insertion failure, pain (on insertion), procedural time, patient/parent satisfaction (with insertion), device dwell time, device complications during dwell time, additional vascular access devices required to complete treatment, clinician satisfaction (at removal), and health care costs. Results: Of the 128 patients randomly assigned to study groups, 127 patients (median [IQR] age, 7 [2-13] years; 71 male [56%]) had a device inserted, with 65 (51.2%) in the PIVC group and 62 (48.8%) in the MC group. All patients were included in the intention-to-treat analysis. Device failure was lower in patients in the MC group (10 [16.1%]) compared with those in the PIVC group (30 [46.2%]; odds ratio [OR], 0.22; 95% CI, 0.10-0.52; P <.001). MCs were associated with fewer insertion attempts (mean difference [MD], -0.3; 95% CI, -0.5 to 0; P = .04), increased dwell time (MD, 66.9 hours; 95% CI, 36.2-97.5 hours; P <.001), and fewer patients required additional vascular access devices to complete treatment in the MC group (4 [6.5%]) and PIVC group (19 [29.2%]; OR, 0.17; 95% CI, 0.05-0.52; P = .002). Compared with PIVCs, use of MCs was associated with greater patient (9.0 vs 7.1 of 10; P = .002) and parent (9.1 vs 8.2 of 10; P = .02) satisfaction and lower health care costs (AUS -$151.67 [US -$101.13] per person; 95% credible interval, AUS -$171.45 to -$131.90 [US -$114.20 to -$87.95]). Conclusions and Relevance: Findings suggest that MC insertion for patients requiring peripherally compatible intravenous therapy for 4 days or longer should be prioritized to reduce the resource intensive, expensive, and burdensome sequelae of device failure. Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12620000724976.

Ultrasound-guided PIVC insertion: a randomised controlled trial protocol.

Ultrasound-guided insertion of peripheral intravenous catheters (PIVCs) is an alternative to traditional anatomical landmark-based insertion. However, data on its performance in paediatric patients of varying levels of difficult intravenous access are limited. The researchers hypothesise that ultrasound-guided PIVC insertion will increase first-attempt success compared with landmark technique. This randomised, parallel-group, single-centre, superiority trial commenced recruiting in July 2021, including hospitalised children (aged 0 (>37 weeks gestation) to 18 years) requiring a PIVC. It will recruit 180 children, stratified by degree of perceived difficulty, and centrally randomised into two groups (ratio 1:1). The primary outcome is first-attempt PIVC insertion success. Secondary outcomes include total number of PIVC insertion attempts, PIVC insertion failure, post-insertion complications, dwell time, patient/parent satisfaction, and healthcare costs. The current study will inform the superiority of ultrasound-guided PIVC insertion in comparison with landmark technique. Adoption by healthcare facilities might improve patient outcomes and decrease healthcare costs.

Improving difficult peripheral intravenous access requires thought, training and technology (DART3): a stepped-wedge, cluster randomised controlled trial protocol.

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).

The parent, child and young person experience of difficult venous access and recommendations for clinical practice: A qualitative descriptive study.

AIMS AND OBJECTIVES: Explore the parent and child/young person experience of difficult venous access and identify ideas and preferences for changes to clinical practice. BACKGROUND: Peripheral intravenous catheter insertion is one of the most common invasive procedures in hospitalised paediatric patients. Multiple insertion attempts in paediatric patients are common and associated with pain and distress. Little research has explored the parent and child/young person experience of difficult venous access nor sought to identify their suggestions to improve clinical practice. DESIGN: Qualitative description. METHODS: A purposive sampling approach was used to identify children and young people with experience of difficult venous access and their parents. Semi-structured interviews were conducted, with sample size based on data saturation. Transcripts were analysed using thematic analysis. RESULTS: There were 12 participants, seven parents and five children/young people (five parent/child dyads and two individual parents). Analysis of the data revealed three main themes: (1) Distress-before, during and after (2) Families navigating the system: the challenging journey from general clinician to specialist and (3) Difficult venous access impacts both treatment and life outside the hospital A pre-determined theme, (4) Recommendations for good clinical practice is also described. CONCLUSIONS: Multiple attempts to insert a peripheral intravenous catheter are a source of substantial distress for children/young people, leading to treatment avoidance. Effective interpersonal skills, providing choice and avoiding frightening language are important to minimise distress. Clinicians without specialist training should assess each child's venous access experience and consider immediate referral to a specialist if they have a history of difficult venous access. Cultural change is required so clinicians and healthcare services recognise that repeated cannulation may be a source of psychological distress for children/young people.

Comparing the use of midline catheters versus peripherally inserted central catheters for patients requiring peripherally compatible therapies: A pilot randomised controlled trial (the compact trial).

BACKGROUND: Midline catheter (MC) use has increased in acute-care settings, particularly for patients with difficult venous access or requiring peripherally compatible intravenous therapy for up-to 14 days. Our aim was to assess feasibility and generate clinical data comparing MCs with Peripherally Inserted Central Catheters (PICCs). METHODS: A two-arm parallel group pilot randomised controlled trial (RCT), comparing MCs with PICCs, was conducted in a large tertiary hospital in Queensland between September 2020 and January 2021. The primary outcome was study feasibility, measured against rates of eligibility (>75%), consent (>90%), attrition (<5%); protocol adherence (>90%) and missing data (<5%). The primary clinical outcome was all-cause device failure. RESULTS: In total, 25 patients were recruited. The median patient age was 59-62 years; most patients were overweight/obese, with ≥2 co-morbidities. PRIMARY OUTCOMES: The eligibility and protocol adherence criteria were not met; of 159 screened patients, only 25 (16%) were eligible, and three patients did not receive their allocated intervention post-randomisation (88% adherence). All-cause failure occurred in two patients allocated to MC (20%) and one PICC (8.3%). CONCLUSIONS: Our study found that a fully powered RCT testing MCs compared with PICCs is not currently feasible in our setting. We recommend a robust process evaluation before the introduction of MCs into clinical practice.

Quality measurement and surveillance platforms in critically ill children: A scoping review.

BACKGROUND/AIM: The objective of this study was to describe current surveillance platforms which support routine quality measurement in paediatric critical care. METHOD: Scoping review. The search strategy consisted of a traditional database and grey literature search as well as expert consultation. Surveillance platforms were eligible for inclusion if they collected measures of quality in critically ill children. RESULTS: The search strategy identified 21 surveillance platforms, collecting 57 unique outcome (70%), process (23%), and structural (7%) quality measures. Hospital-associated infections were the most commonly collected outcome measure across all platforms (n = 11; 52%). In general, case definitions were not harmonised across platforms, with the exception of nationally mandated hospital-associated infections (e.g., central line-associated blood stream infection). Data collection relied on manual coding. Platforms typically did not provide an evidence-based rationale for measures collected, with no identifiable reports of co-designed, consensus-derived measures or consumer involvement in measure selection or prioritisation. CONCLUSIONS: Quality measurement in critically ill children lacks uniformity in definition which limits local and international benchmarking. Current surveillance activities for critically ill children focus heavily on outcome measurement, with process, structural, and patient-reported measures largely overlooked. Long-term outcome measures were not routinely collected. Harmonisation of paediatric intensive care unit quality measures is needed and can be achieved using prioritisation and consensus/co-design methods.

Safety and efficacy of midline catheters versus peripheral intravenous catheters: A pilot randomized controlled trial.

BACKGROUND: Despite pervasive need for peripheral intravenous catheters, insertion is often difficult, and approximately two thirds fail prematurely. Midline catheters are an alternative long peripheral catheter, inserted in the upper arm, ideal for patients with difficult access. AIM: The aim of this study is to test feasibility of the protocol and compare the efficacy and safety of midline catheters to peripheral intravenous catheters. DESIGN: A parallel-group, pilot randomized controlled trial of adult medical/surgical hospitalized patients, from a single Australian referral hospital. METHODS: Participants with difficult vascular access (≤2 palpable veins) and/or anticipated ≥5 days of peripherally compatible intravenous therapy were recruited between May 2019 and March 2020. Participants were randomized to (1) peripheral intravenous catheter or (2) midline catheter. Primary feasibility outcome measured eligibility, recruitment, protocol adherence, retention and attrition. Primary clinical outcomes measured device insertion failure and post-insertion failure. RESULTS: In total, n = 143 participants (71 peripheral intravenous catheters and 72 midline catheters) were recruited; n = 139 were analysed. Most feasibility criteria were met. Peripheral intravenous catheters had shorter functional dwell time, with higher incidence of post-insertion failure compared to midline catheters. CONCLUSION: Midline catheters appear to be superior for patients with difficult vascular access or receiving prolonged intravenous therapy; a large, multi-centre trial to confirm findings is feasible.

Experiences of children with central venous access devices: a mixed-methods study.

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.

Review article: Peripheral intravenous catheter insertion in adult patients with difficult intravenous access: A systematic review of assessment instruments, clinical practice guidelines and escalation pathways.

The optimal approach for peripheral intravenous catheter (PIVC) insertion in adult hospitalised patients with difficult intravenous access (DIVA) is unknown. The present study aimed to critically appraise the quality of (i) assessment instruments and (ii) clinical practice guidelines (CPGs) or escalation pathways for identifying and managing patients with DIVA. Cochrane Central Register of Controlled Trials, EBSCO MEDLINE, EMBASE (OVID) and EBSCO CINAHL databases were searched on 22 March 2021. Studies describing a DIVA assessment measure, CPG or escalation pathway for PIVC insertion in adults (≥18 years of age) were included. Data were extracted using a standardised data extraction form including study design, type of resource and reported clinical outcomes. Quality of DIVA assessment instruments were reviewed using the COnsensus-based Standards for the selection of health Measurement Instruments checklist. Methodological quality of CPGs and escalation pathways was assessed using the Appraisal of Guidelines for Research and Evaluation-II (AGREE-II) instrument. Overall, 24 DIVA resources comprising 16 DIVA assessment instruments and nine CPGs or escalation pathways (including one combined assessment instrument and escalation pathway) were identified. Instruments commonly focused on vein visibility and palpability as indicators of DIVA. CPGs and escalation pathways unanimously recommended use of vessel visualisation technology for patients with or suspected of DIVA. Methodological quality of the resources was mixed. Consensus and standardisation of resources to identify DIVA and recommendations for managing patients with DIVA is limited. Adopting consistent, evidence-based CPGs, escalation pathways or DIVA assessment instruments may significantly improve clinical outcomes.

Comparison of ultrasound-guided peripheral intravenous catheter insertion with landmark technique in paediatric patients: A systematic review and meta-analysis.

BACKGROUND: Paediatric peripheral intravenous catheter (PIVC) insertion using traditional landmark insertion technique can be difficult. AIM: To systematically review the evidence comparing landmark to ultrasound guidance for PIVC insertion in general paediatric patients. STUDY DESIGN: Cochrane methodology to systematically search for randomised controlled trials comparing landmark to ultrasound-guided PIVC insertion. DATA SOURCES: Cochrane Central Register of Controlled Trials, US National Library of Medicine, Cumulative Index to Nursing and Allied Health, Embase. DATA EXTRACTION: English-language, paediatric trials published after 2000, reporting first-attempt insertion success, overall PIVC insertion success, and/or time to insert were included. Central venous, non-venous and trials including only difficult intravenous access were excluded. Data were independently extracted and critiqued for quality using GRADE by three authors, and analysed using random effects, with results expressed as risk ratios (RR), mean differences (MD) and 95% confidence intervals (CI). Registration (CRD42020175314). RESULTS: Of 70 titles identified, 5 studies (995 patients; 949 PIVCs) were included. There was no evidence of an effect of ultrasound guidance, compared to landmark, for first-attempt insertion success (RR 1.27; 95% CI 0.90-1.78; I2  = 88%; moderate quality evidence), overall insertion success (RR 1.14; 95% CI 0.90-1.44; I2  = 82%; low quality evidence), or time to insertion (mean difference -3.03 min; 95% CI -12.73 to 6.67; I2  = 92%; low quality evidence). LIMITATIONS: Small sample sizes, inconsistent outcomes and definitions in primary studies precluded definitive conclusions. CONCLUSIONS: Large clinical trials are needed to explore the effectiveness of ultrasound guidance for PIVC insertion in paediatrics. Specifically, children with difficult intravenous access might benefit most from this technology.

Comparing ivWatch biosensor to standard care to identify extravasation injuries in the paediatric intensive care: a protocol for a randomised controlled trial.

INTRODUCTION: Peripheral 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 ANALYSIS: A 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 DISSEMINATION: This 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 NUMBER: ACTRN12620000317998.

Intravenous antimicrobial administration through peripheral venous catheters - establishing risk profiles from an analysis of 5252 devices.

INTRODUCTION: Peripheral venous catheters (PVCs) are used to administer antimicrobials, but many fail prior to completion of therapy. While some antimicrobials are known to increase the PVC failure rate, risk profiles for many are unclear. OBJECTIVE: To synthesize data from prospective PVC studies conducted between 2013 and 2019 to determine associations between common antimicrobials and PVC failure. METHODS: A secondary analysis was undertaken of seven randomized controlled trials and two prospective cohort studies from three quaternary hospitals (two adult and one paediatric) in Australia between 2013 and 2019. The primary outcome was PVC failure due to vessel injury (occlusion, infiltration or extravasation) or irritation (pain or phlebitis). Associations between antimicrobial use and PVC failure were explored using multi-variable Cox regression. RESULTS: In total, 5252 PVCs (4478 patients) were analysed; vessel injury and irritations occurred in 19% and 11% of all PVCs, respectively. Vessel injury was significantly associated with cefepime hydrochloride [hazard ratio (HR) 2.50; 95% confidence interval (CI) 1.44-4.34], ceftazidime pentahydrate (HR 1.91, 95% CI 1.11-3.31), flucloxacillin sodium (HR 1.84, 95% CI 1.45-2.33), lincomycin hydrochloride (HR 1.67, 95% CI 1.10-2.52) and vancomycin hydrochloride (HR 1.73, 95% CI 1.25-2.40). Irritation was significantly associated with flucloxacillin sodium (HR 2.58, 95% CI 1.96-3.40). CONCLUSIONS: This study identified several antimicrobials associated with increased PVC failure, including some that were already known to be associated and some that had not been identified previously. Research is needed urgently to determine superior modes of delivery (e.g. dilution, infusion time, device type) that may prevent PVC failure.

Improving peripheral venous cannula insertion in children: a mixed methods study to develop the DIVA key.

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.

Pediatric central venous access devices: practice, performance, and costs.

BACKGROUND: Healthcare delivery is reliant on a functional central venous access device (CVAD), but the knowledge surrounding the burden of pediatric CVAD-associated harm is limited. METHODS: A 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). RESULTS: 163 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. CONCLUSIONS: CVAD complications and failures represent substantial burdens to children and healthcare. Future efforts need to focus on the inconsistent use of best practices. IMPACT: Current 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.

Do antimicrobial and antithrombogenic peripherally inserted central catheter (PICC) materials prevent catheter complications? An analysis of 42,562 hospitalized medical patients.

OBJECTIVE: To examine the effectiveness of antimicrobial and antithrombogenic materials incorporated into peripherally inserted central catheters (PICCs) to prevent bloodstream infection, thrombosis, and catheter occlusion. METHODS: Prospective cohort study involving 52 hospitals participating in the Michigan Hospital Medicine Safety Consortium. Sample included adult hospitalized medical patients who received a PICC between January 2013 and October 2019. Coated and impregnated catheters were identified by name, brand, and device marketing or regulatory materials. Multivariable Cox proportional hazards models with robust sandwich standard error estimates accounting for the clustered nature of data were used to identify factors associated with PICC complications in coated versus noncoated devices across general care, intensive care unit (ICU), and oncology patients. Results were expressed as hazard ratios (HRs) with corresponding 95% confidence intervals (CIs). RESULTS: Of 42,562 patients with a PICC, 39,806 (93.5%) were plain polyurethane, 2,263 (5.3%) incorporated antimicrobial materials, and 921 (2.2%) incorporated antithrombogenic materials. Most were inserted in general ward settings (n = 28,111, 66.0%), with 12, 078 (28.4%) and 1,407 (3.3%) placed in ICU and oncological settings, respectively. Within the entire cohort, 540 (1.3%) developed thrombosis, 745 (1.8%) developed bloodstream infection, and 4,090 (9.6%) developed catheter occlusion. Adjusting for known risk factors, antimicrobial PICCs were not associated with infection reduction (HR, 1.16; 95% CI, 0.82-1.64), and antithrombogenic PICCs were not associated with reduction in thrombosis and occlusion (HR, 1.15; 95% CI, 0.92-1.44). Results were consistent across populations and care settings. CONCLUSIONS: Antimicrobial and antithrombogenic PICCs were not associated with a reduction in major catheter complications. Guidance aimed at informing use of these devices, balancing benefits against cost, appear necessary.

Techniques and Technologies to Improve Peripheral Intravenous Catheter Outcomes in Pediatric Patients: Systematic Review and Meta-Analysis.

OBJECTIVE: Insertion and function of pediatric peripheral intravenous catheters (PIVCs) present challenges. We systematically reviewed techniques and technologies to improve PIVC outcomes (first-time insertion success, overall insertion success, time to insertion, dwell time, failure, and complications). DATA SOURCES: Cochrane Central Register of Controlled Trials (CONTROL), Cumulative Index to Nursing and Allied Health (CINAHL), US National Library of Medicine, and Embase. STUDY SELECTION: English-language pediatric trials published post 2010 reporting PIVC outcomes. DATA EXTRACTION: Following Cochrane standards, two authors screened, extracted, and critiqued study quality (Grading of Recommendations Assessment, Development and Evaluation approach) data, random effects analysis, results expressed as risk ratios (RR), mean differences (MD) and 95% CIs. RESULTS: Twenty-one studies (3237 children; 3098 PIVCs) were included. First-time insertion success significantly increased with ultrasound guidance (compared with landmark insertion; RR, 1.60; 95% CI, 1.02-2.50). Use of ultrasound guidance (compared with landmark insertion) did not improve overall PIVC insertion success (RR, 1.10; 95% CI, 0.94-1.28). There was no evidence of an effect of near-infrared (compared with landmark) on first-time insertion success (RR, 1.21; 95% CI, 0.91-1.59) or number of attempts (MD, -0.65; 95% CI, -1.59 to 0.29); however, it significantly reduced PIVC insertion time (MD, -132.47; 95% CI, -166.68 to -98.26) and increased first-time insertion success in subgroup analysis of patients with difficult intravenous access (RR, 2.72; 95% CI, 1.02-7.24). LIMITATIONS: Few studies per intervention, small sample sizes, and inconsistent outcome measures precluded definitive conclusions. CONCLUSIONS: Ultrasound and near-infrared appear to improve pediatric PIVC insertion. High-quality studies examining the full extent of techniques and technologies are needed. Registration: CRD42020175314.