Using a LOng peripheral intraVEnous catheter with retractable guidewire to optimize first-insertion success for patients with Difficult IntraVenous Access in the emergency department (LOVE-DIVA): a study protocol for a randomized controlled trial.

INTRODUCTION: First-insertion success rates for peripheral vascular access devices (PVADs) in patients with difficult venous access (DIVA) are low, which negatively affects staff workload, patient experience, and organizational cost. There is mixed evidence regarding the impact of a peripheral vascular access device with retractable coiled tip guidewire (GW; AccuCath™, BD) on the first-insertion success rate. The aim of this study is to investigate whether the use of long GW-PVADs, compared with standard PVADs, reduces the risk of first-time insertion failure, in patients admitted to emergency departments (EDs). METHODS AND ANALYSIS: A parallel-group, two-arm, randomized controlled trial will be carried out in two Australian EDs to compare long GW-PVADs (5.8 cm length) against standard care PVADs (short or long). Patients ≥18 years of age meeting DIVA criteria will be eligible for the trial. The sample size is 203 participants for each arm. Web-based central randomization will be used to ensure allocation concealment. Neither clinicians nor patients can be blinded to treatment allocation. Primary outcome is the first-insertion success rate. Secondary outcomes include the number of insertion attempts, time to insert PVAD, all-cause failure, dwell-time, patient-reported pain, serious adverse events, complications, subsequent vascular access devices required, patient satisfaction, staff satisfaction, and healthcare costs. Differences between the two groups will be analyzed using Cox proportional hazards regression. Cost-effectiveness analysis will also be conducted. Intention-to-treat analysis will be used. ETHICS AND DISSEMINATION: The study is approved by Metro South Ethics Committee (HREC/2022/QMS/82264) and Griffith University (2022/077). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION: ACTRN12622000299707.

Central Venous Access Device-Associated Skin Complications in Adults with Cancer: A Prospective Observational Study.

OBJECTIVES: To identify the prevalence and type of central venous access device-associated skin complications for adult cancer patients, describe central venous access device management practices, and identify clinical and demographic characteristics associated with risk of central venous access device-associated skin complications. METHODS: A prospective cohort study of 369 patients (626 central venous access devices; 7,682 catheter days) was undertaken between March 2017 and March 2018 across two cancer care in-patient units in a large teaching hospital. RESULTS: Twenty-seven percent (n = 168) of participants had a central venous access device-associated skin complication. In the final multivariable analysis, significant (P < .05) risk factors for skin complications were cutaneous graft versus host disease (2.1 times greater risk) and female sex (1.4 times greater risk), whereas totally implanted vascular access device reduced risk for skin complications by two-thirds (incidence risk ratio 0.37). CONCLUSION: Central venous access device-associated skin complications are a significant, potentially avoidable injury, requiring cancer nurses to be aware of high-risk groups and use evidence-based preventative and treatment strategies. IMPLICATIONS FOR PRACTICE: This study has confirmed how common these potentially preventable injuries are. Therefore, the prevalence of these complications could be reduced by focusing on improvements in skin assessment, reductions in central venous access device dressing variation and improving clinician knowledge of this injury.

Exploring clinicians' insertion experience with a new peripheral intravenous catheter in the emergency department.

BACKGROUND: Hospitals frequently introduce new medical devices. However, the process of clinicians adapting to these new vascular access devices has not been well explored. The study aims to explore clinicians' experience with the insertion of a new guidewire peripheral intravenous catheter (PIVC) introduced in the emergency department (ED) setting. METHODS: The study was conducted at two EDs in Queensland, Australia, utilising a qualitative explorative approach. Interviews were conducted with guidewire PIVC inserters, including ED doctors and nurses, and field notes were recorded by research nurses during insertions. Data analysis was performed using inductive content analysis, from which themes emerged. RESULTS: The study compiled interviews from 10 participants and field notes from 191 observation episodes. Five key themes emerged, including diverse experience, barriers related to the learning process, factors influencing insertion success, and recommendations to enhance clinicians' acceptance. These themes suggest that the key to successful adoption by clinicians lies in designing user-friendly devices that align with familiar insertion techniques, facilitating a smooth transfer of learning. CONCLUSION: Clinician adaptation to new devices is vital for optimal patient care. Emergency nurses and doctors prefer simplicity, safety, and familiarity when it comes to new devices. Providing comprehensive device training with diverse training resources, hands-on sessions, and continuous expert support, is likely to enhance clinician acceptance and the successful adoption of new devices in ED settings.

Risk factors for arterial catheter failure and complications during critical care hospitalisation: a secondary analysis of a multisite, randomised trial.

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.

The effects of intravenous hydration regimens in nulliparous women undergoing induction of labor: A systematic review and meta-analysis.

INTRODUCTION: Labor is both a physiological and physical activity that requires energy expenditure by the woman. Despite this, women are often fasted in labor, with hydration requirements addressed predominantly by intravenous therapy. Little is known about how best to manage this in nulliparous women undergoing induction of labor, who can be prone to lengthy labors. Therefore, we undertook a systematic review and meta-analysis to determine the effects of intravenous hydration regimens on nulliparous women undergoing induction of labor. MATERIAL AND METHODS: A systematic review and meta-analysis were conducted. Databases searched were PubMed, CINAHL, Embase, Cochrane, Scopus, and Web of Science using the search strategy combination of associated key concepts for intravenous therapy and nulliparous laboring women. The primary outcome was excessive neonatal weight loss. Meta-analyses for categorical outcomes included estimates of odds ratio (OR) and their 95% confidence intervals (CI) calculated; and for continuous outcomes the standardized mean difference, each with its 95% CI. Heterogeneity was assessed visually and by using the χ2 statistic and I2 with significance being set at p < 0.10. RESULTS: A total of 1512 studies were located and following screening, three studies met the eligibility criteria. No studies reported excessive neonatal weight loss. Increased rates of intravenous therapy (250 mL/h vs. 125 mL/h) during labor were not found to reduce the overall length of labor (mean difference -0.07 h, 95% CI -0.27 to 0.13 h) or reduce cesarean sections (OR 0.74, 95% CI 0.45-1.23), when women were not routinely fasted. CONCLUSIONS: Our review found no significant improvements for nulliparous women who received higher intravenous fluid volumes when undergoing induction of labor and were not routinely fasted. However, data are limited, and further research is needed.

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.

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.

A scoping review and narrative synthesis of neonatal skin injury severity scales.

BACKGROUND: Mechanical force skin injuries are common for critical care patients, especially neonates. Currently, identification and severity assessments of injuries are dependent on clinical experience and/or utilization of severity tools. Compared with adults, neonates sustain skin injuries in different anatomical locations and have decreased layers of healthy tissue (from 0.9 to 1.2 mm) creating questions around direct application of adult injury severity scales reliant on visual assessment. AIMS: The aim of this scoping review (ScR) was to investigate severity scales used to report hospital acquired skin injuries for neonates. METHODS: This study utilized the 2015 Joanna Briggs Institute methodology for scoping reviews and is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews extension. PubMed, CINAHL, COCHRANE Central, Scopus, and the reference lists of included studies were searched for studies published between 2001 and 2023, that included severity scales use within neonatal population. Two authors independently identified studies for full review, data extraction, and quality assessment. RESULTS: A systematic database search returned 1163 records. After full test review of 109 studies, 35 studies were included. A majority of studies included were cohort or action research and conducted in the United States of America. Most studies (57%, n = 20) reported skin injuries acquired throughout the body, 14 (40%) of the studies reported the nasal area alone and one study reported no anatomical location. A total of nine severity scales or combination of scales were utilized within studies (n = 31) and four studies did not report a scale. Various versions of scales from the National Pressure Ulcer Advisory Panel (n = 16), European Pressure Ulcer Advisory Panel (n = 8) or Neonatal Skin Condition Score (n = 4) were reported, compared with locally developed classifications/scales (n = 4). Scales were predominantly of ordinal grouping (74%, n = 26) or categorical assessment (14%, n = 5). Only one scale from 2004 was validated for neonates. CONCLUSION: Neonatal skin injuries will continue to be reported subjectively until severity scales are consistently applied or other measurements are identified to support assessment. Additionally, without skin injury assessment uniformity, critical examination of effectiveness of skin care treatment practices will have subjective comparison. This review suggests there is a need for consistent skin assessment and severity scales that are valid for the neonatal population and their unique skin considerations.

Health-related quality of life and experience measures, to assess patients' experiences of peripheral intravenous catheters: a secondary data analysis.

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 < 0.20) responsiveness. CONCLUSIONS: Initial investigation of an existing health-related quality of life measure (EQ5D-5L) and two patient-reported experience measures (FACIT-TS-G; AHPEQS) suggest they are inadequate (as a summary measure) to assess outcomes and experiences for patients with PIVCs. Reliable instruments are urgently needed to inform quality improvement and benchmark standards of care.

Peripheral intravenous catheter infection and failure: A systematic review and meta-analysis.

BACKGROUND: Peripheral intravenous catheters are the most frequently used invasive device in nursing practice, yet are commonly associated with complications. We performed a systematic review to determine the prevalence of peripheral intravenous catheter infection and all-cause failure. METHODS: The Cochrane Library, PubMed, CINAHL, and EMBASE were searched for observational studies and randomised controlled trials that reported peripheral intravenous catheter related infections or failure. The review was limited to English language and articles published from the year 2000. Pooled estimates were calculated with random-effects models. Meta-analysis of observation studies in epidemiology guidelines and the Cochrane process for randomised controlled trials were used to guide the review. Prospero registration number: CRD42022349956. FINDINGS: Our search retrieved 34,725 studies. Of these, 41 observational studies and 28 randomised controlled trials (478,586 peripheral intravenous catheters) met inclusion criteria. The pooled proportion of catheter-associated bloodstream infections was 0.028 % (95 % confidence interval (CI): 0.009-0.081; 38 studies), or 4.40 catheter-associated bloodstream infections per 100,000 catheter-days (20 studies, 95 % CI: 3.47-5.58). Local infection was reported in 0.150 % of peripheral intravenous catheters (95 % CI: 0.047-0.479, 30 studies) with an incidence rate of 65.1 per 100,000 catheter-days (16 studies; 95 % CI: 49.2-86.2). All cause peripheral intravenous catheter failure before treatment completion occurred in 36.4 % of catheters (95 % CI: 31.7-41.3, 53 studies) with an overall incidence rate of 4.42 per 100 catheter days (78,891 catheter days; 19 studies; 95 % CI: 4.27-4.57). INTERPRETATION: Peripheral intravenous catheter failure is a significant worldwide problem, affecting one in three catheters. Per peripheral intravenous catheter, infection occurrence was low, however, with over two billion catheters used globally each year, the absolute number of infections and associated burden remains high. Substantial and systemwide efforts are needed to address peripheral intravenous catheter infection and failure and the sequelae of treatment disruption, increased health costs and poor patient outcomes.

Neonatal Vascular Access Practice and Complications: An Observational Study of 1,375 Catheter Days.

Vascular access devices play vital roles within neonatal care. We aimed to identify neonatal vascular access device insertion and management practices, and describe the incidence and risk factors for complication development. This is a prospective cohort study of neonates requiring vascular access devices over 3 months in an Australian quaternary-referral neonatal intensive care unit. In addition to describing current practices, primary outcomes were device failure, complications, and skin complications. Results are reported using descriptive statistics and with risk factors calculated via Cox proportional hazards regression. A total of 104 neonates required 302 vascular access devices, over 1375 catheter days. Peripheral intravenous catheters (PIVCs) were most used (n = 186; 62%), followed by umbilical venous catheters (n = 52; 17%). Insertion attempts were often undocumented; but for those recorded, 5% of devices (n = 15) required 4 attempts or more. Device failure occurred in 28% (n = 82), at an incidence rate of 62.5 per 1000 catheter days (95% confidence interval [CI] 49.7-75.9). Failure was most frequent in PIVCs (37%; n = 68), peripheral arterial catheters (33%; n = 2), and peripherally inserted central catheters (20%; n = 6). Infiltration and extravasation were the most frequent cause of PIVC failure (12%; n = 35). A birth weight less than 1500 g was associated with a significant decrease in PIVC failure (hazard ratio 0.58; 95% CI 0.34-0.99).

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.

Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlled trial.

AIM: To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). DESIGN: A single-centre, parallel-group, pilot randomised control trial. METHODS: Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. RESULTS: In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). CONCLUSION: With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. REPORTING METHOD: Study methods and results reported in adherence to the CONSORT Statement. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Educational programs for implementing ultrasound guided peripheral intravenous catheter insertion in emergency departments: A systematic integrative literature review.

BACKGROUND: Ultrasound-guided peripheral intravenous catheter insertion has been identified as an effective method to improve the success rate of cannulation, thereby improving patient experience. However, learning this new skill is complex, and involves training clinicians from a variety of backgrounds. The aim of this study was to appraise and compare literature on educational methods in the emergency setting used to support ultrasound guided peripheral intravenous catheter insertion by different clinicians, and how effective these current methods are. REVIEW METHODS: A systematic integrative review was undertaken using Whittemore and Knafl's five stage approach. The Mixed Methods Appraisal Tool was used to assess the quality of the studies. RESULTS: Forty-five studies met the inclusion criteria, with five themes identified. These were: the variety of educational methods and approaches; the effectiveness of the different educational methods; barriers and facilitators of education; clinician competency assessments and pathways; clinician confidence assessment and pathways. CONCLUSIONS: This review demonstrates that a variety of educational methods are being used in successfully training emergency department clinicians in using ultrasound guidance for peripheral intravenous catheter insertion. Furthermore, this training has resulted in safer and more effective vascular access. However, it is evident that there is a lack of consistency of formalised education programs available. A standardised formal education program and increased availability of ultrasound machines in the emergency department will ensure consistent practices are maintained, retained, therefore leading to safer practice as well as more satisfied patients.

Peripheral intravenous catheter material and design to reduce device failure: A systematic review and meta-analysis.

BACKGROUND: Patients require vascular access for medical treatments, diagnostic procedures and symptom management. Current failure rates of peripheral intravascular catheters (PIVCs) are unacceptably high (40-50%). This systematic review aimed to determine the effect of different PIVC materials and designs on the incidence of PIVC failure. METHODS: A systematic search was conducted in November 2022 using CINAHL, PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases. Randomised controlled trials that compared PIVC novel PIVC material/design and standard material/design were included. The primary outcome was all causes of PIVC failure, any reason for device removal due to cessation of device function; and secondary outcomes included individual PIVC complications and infection (local or systemic), and dwell times. Quality appraisal was conducted using the Cochrane risk of bias tool. A meta-analysis was performed using random effects model. RESULTS: Seven randomised controlled trials were eligible for inclusion. In meta-analysis, the impact of material and design on PIVC failure in the studies favoured the intervention arms (RR 0.71, 95% CI 0.57-0.89), however there was substantial heterogeneity (I2 = 81%, 95% CI 61-91%). Through subgroup analyses, a significant difference on PIVC failure favoured the closed system over the open system (RR 0.85, 95% CI 0.73 to 0.99; I2 = 23%, 95% CI 0-90%). CONCLUSION: Catheter material and design can impact PIVC outcome. Conclusive recommendations are limited due to the small number of studies and inconsistent reporting of clinical outcomes. Further rigorous research of PIVC types is necessary to improve clinical practice and device selection pathways should reflect the resulting evidence.

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).

Comparison of Low-Level to High-Level Disinfection in Eliminating Microorganisms From Ultrasound Transducers Used on Skin: A Noninferiority Randomized Controlled Trial.

INTRODUCTION: There is a lack of international consensus as to whether high- or low-level disinfection (HLD or LLD) is required for ultrasound (US) transducers used during percutaneous procedures. This study compared the effectiveness of LLD to HLD on US transducers contaminated with microorganisms from skin. METHODS: Two identical linear US transducers repeatedly underwent either LLD or HLD during the study. Randomization determined which of these transducers was applied to left and right forearms of each participant. Swabs taken from transducers before and after reprocessing were plated then incubated for 4-5 days, after which colony forming units (CFU) were counted and identified. The primary hypothesis was the difference in the proportion of US transducers having no CFUs remaining after LLD and HLD would be less than or equal to the noninferiority margin of -5%. RESULTS: Of the 654 recruited participants 73% (n = 478) had microbial growth from both transducers applied to their left and right forearms before reprocessing. These were included in the paired noninferiority statistical analysis where, after disinfection, all CFUs were eliminated in 100% (95% CI: 99.4-100.0%) of HLD transducer samples (n = 478) and 99.0% (95% CI: 97.6-99.7%) of LLD transducer samples (n = 473). The paired difference in the proportion of transducers having all CFUs eliminated between LLD and HLD was -1.0% (95% CI: -2.4 to -0.2%, P-value <.001). CONCLUSIONS: Disinfection with LLD is noninferior to HLD when microorganisms from skin have contaminated the transducer. Therefore, using LLD for US transducers involved in percutaneous procedures would present no higher infection risk compared with HLD.

Perforated intravenous catheter design is acceptable for the administration of contrast-enhanced computed tomography administration in cancer patients: Results of a pilot randomised controlled trial.

BACKGROUND: Optimising first time success of peripheral intravenous catheter (PIVC) insertion and reducing intravenous (IV) complications in cancer patients undergoing contrast-enhanced computed tomography (CT) is vital to ensure vascular access preservation and diagnostic accuracy. The aim of this study was to test the feasibility of a randomised controlled trial (RCT) evaluating a novel perforated PIVC compared to a standard PIVC. METHODS: A single centre, parallel-group, pilot RCT was conducted between March and May 2020. Adult participants diagnosed with cancer were randomised to a non-perforated PIVC (standard care) or a PIVC with a novel perforated design (intervention) for the administration of IV contrast. There were two primary outcomes: (1) feasibility of an adequately powered RCT with pre-established criteria; and (2) all-cause PIVC failure. Secondary outcomes included: first insertion success, modes of PIVC failure, dwell time, contrast injection parameters (volume and injection rate), contrast enhancement, radiographer satisfaction and adverse events. RESULTS: Feasibility outcomes were met, except for eligibility (⩾90%) and recruitment (⩾90%). In total, 166 participants were screened, 128 (77%) were eligible and of these 101/128 (79%) were randomised; 50 to standard care and 51 to intervention. First time insertion rate was 94% (47/50) in standard care and 90% (46/50) in intervention. The median dwell time was 37 minutes (interquartile range (IQR): 25-55) in standard care and 35 minutes (IQR: 25-60) in the intervention group. There was one PIVC failure, a contrast media extravasation, in the intervention group (1/51; 2%). The desired contrast injection rate was not achieved in 4/101 (4%) of participants; two from each group. Radiographers were satisfied with the contrast flow rate. CONCLUSIONS: This pilot RCT suggests perforated PIVCs provide expected flow rate, with no evidence of differences in contrast enhancement to non-perforated PIVCs. The feasibility of conducting a larger powered RCT was demonstrated.

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.