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.

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.

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 practice across haematology and oncology centres in Australia and New Zealand: a cross-sectional survey.

Central venous access devices (CVADs) are commonly used in malignancies. We conducted an online, anonymous cross-sectional survey of practice regarding CVAD management in haematology centres among clinicians in Australia and New Zealand. We identified variation in clinical practice regarding CVAD selection, insertion, management and removal. These findings highlight research gaps in CVAD care.

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.

Peripheral intravenous catheter securement: An integrative review of contemporary literature around medical adhesive tapes and supplementary securement products.

AIM: To synthesise evidence related to medical adhesive tapes and supplementary securement products for peripheral intravenous catheters in adults, to prevent complications and device failure. DESIGN: Integrative review informed by Whittemore and Knafl and reported in accordance with the PRISMA 2020 statement. DATA SOURCES: The Cochrane Central Register of Controlled Trials, US National Library of Medicine National Institutes of Health, EMBASE/MEDLINE and Cumulative Index to Nursing and Allied Health were searched from 2000-21 September 2020. REVIEW METHODS: Studies enrolling hospitalised participants >16 years with peripheral intravenous catheters secured by medical adhesive tapes, or supplementary products (bandage, splint and sutureless securement device), were eligible. Quality appraisal was performed using Critical Appraisal Skills Program checklists. RESULTS: Nineteen studies met criteria, including 43,683 peripheral intravenous catheters. Quality appraisal identified high or unclear risk of bias in 58% of studies. Nonsterile tape was the most common intervention tested (14 studies), alone or in multiproduct combinations. Nonsterile tape directly over insertion sites was associated with increased PIVC failure and complications. Sutureless securement devices potentially reduce failure and complications. Multiproduct combinations were very common. Practice recommendations regarding other tapes and secondary securement products are challenging, due to conflicting, or lack of, evidence. CONCLUSION: Tapes and secondary securement product evidence are limited, and over half of the studies are of low methodological quality. This review found nonsterile tape was associated with increased failure and complications; multiproduct dressing and securement bundles were prevalent; and significant evidence gaps exist particularly regarding bandages and splints. The results provide nurses with evidence of medical adhesive tapes and supplementary product effectiveness for peripheral intravenous catheter securement, and future research directions to reduce unacceptably high failure and complication rates. Larger rigorously conducted randomised controlled trials are needed to add to current evidence.

Implementation frameworks, strategies and outcomes used in peripheral intravenous catheter studies: A systematic review.

AIMS: The aim of this study was to critically evaluate implementation frameworks, strategies and/or outcomes used to optimise peripheral intravenous catheter (PIVC) care and/or promote guideline adherence. BACKGROUND: Although a considerable volume of research has investigated the effectiveness of PIVC interventions and treatments to promote performance and prevent harm, how to best implement this evidence into dynamic clinical settings and populations is not well understood. Implementation science is central to translating evidence-based knowledge to the bedside; however, there is a gap in identifying the best implementation framework, strategies and/or outcomes to optimise PIVC care and/or guideline adherence. DESIGN: A systematic review. METHOD: The review was conducted using innovative automation tools. Five databases and clinical trial registries were searched on 14 October 2021. Qualitative and quantitative PIVC intervention studies reporting implementation strategies were included in the review. Data were extracted independently by experienced researchers in pairs. The Mixed Method Appraisal tool was used to assess the quality of individual studies. Narrative synthesis was used to present the findings. The systematic review was reported following the PRISMA checklist. RESULTS: Of 2189 references identified, 27 studies were included in the review. Implementation frameworks were used in 30% (n = 8) of studies, with most used during the preparation (n = 7, 26%) and delivery phase (n = 7, 26%) and then evaluation phase (n = 4, 15%). Multifaceted strategies were commonly adopted (n = 24, 89%) to promote PIVC care or study interventions which were clinician (n = 25, 93%) and patient-targeted (n = 15, 56%). The most commonly reported implementation outcomes were fidelity (n = 13, 48%) and adoption (n = 6, 22%). Most studies were scored as low quality (n = 18, 67%). CONCLUSION: We call for researchers and clinicians to work together and use implementation science frameworks to guide study design, implementation and evaluation in future PIVC studies, to improve evidence translation and thereby improve patient outcomes.

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.

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.

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).

Integrated versus non-integrated peripheral intravenous catheters: a cross-sectional survey of nurse experiences.

BACKGROUND: Integrated peripheral intravenous catheters (PIVCs) demonstrate clinical efficacy, however, device complexity and design differences may be a potential barrier to implementation. AIMS: To assess nurse acceptability of integrated PIVC systems. METHODS: A cross-sectional survey was nested within a multicentre randomised controlled trial. One hundred nurses caring for patients with integrated and non-integrated PIVCs completed a 17-item survey about key differences between devices (eg function and appearance, perceived patient comfort and skin injuries). FINDINGS: Most nurses reported the integrated PIVC wings prevented device movement (80%), achieved patient comfort in areas of flexion (78%), and no patients developed skin injuries (100%). Nurses rated the ease of accessing and overall confidence using the integrated PIVC as significantly higher than the non-integrated design (P<0.001). CONCLUSION: The integrated PIVC received positive feedback from nurses and had few barriers to implementation.

Does longer peripheral intravenous catheter length optimise antimicrobial delivery? Protocol for the LEADER study.

BACKGROUND: Hospitalised patients receiving intravenous antimicrobial therapy require a reliable device through which this is delivered. Short peripheral intravenous catheters (PIVCs) are the default device for antimicrobial therapy but up to half fail before therapy completion, leading to suboptimal drug dosing, patient distress from repeated insertions, and increased healthcare costs. This study will investigate the use of long PIVCs to determine if they are more reliable at delivering antimicrobial therapy. METHODS: A two-arm, parallel randomised controlled trial of hospitalised adults requiring at least 3 days of peripherally compatible intravenous antimicrobials. Participants will be randomised to a short (<4 cm) or long (4.5-6.4 cm) PIVC. After interim analysis ( n=70) for feasibility and safety, 192 participants will be recruited. Primary outcome is disruption to antimicrobial administration from all-cause PIVC failure. Secondary outcomes include: number of devices to complete therapy, patient-reported pain and satisfaction, and a cost analysis. Ethical and regulatory approvals have been received.

Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial.

BACKGROUND: The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters. METHODS: We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device-peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete. FINDINGS: Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI -0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, -0·27% to 0·83%). There were no treatment-related adverse events. INTERPRETATION: Infusion set use can be safely extended to 7 days with resultant cost and workload reductions. FUNDING: Australian National Health and Medical Research Council.

Unnecessary removal of vascular access devices due to suspected infection in Australian intensive care units.

BACKGROUND: Vascular access devices suspected of infection are often removed unnecessarily and frequently require replacement. The aim of this study was to identify the prevalence and economic impact of premature, unnecessary device removal due to suspected infection in adult patients admitted to the intensive care unit. METHODS: Secondary data analysis of a prospectively collected data set detailing central venous catheters and peripheral arterial catheters in 1458 adult patients was conducted in nine Australian intensive care units. Data extracted from the parent database included patient demographics, device, and infection-specific data including the reason for device removal. Cost estimates were based on a recently published review of device utilisation and associated costs in Queensland public hospitals. RESULTS: A total of 6144 central venous catheter days and 4696 arterial catheter days were studied. Median device dwell time was 7.2 (interquartile range: 5.6-9.0) days for central venous catheters and 6.5 (interquartile range: 4.8-8.5) days for arterial catheters. Device removal due to suspected infection occurred at a rate of 25.7 and 15.3 episodes/1000 catheter days in central venous and arterial catheters, respectively. Central venous and arterial catheter-related bloodstream infections occurred at a rate of 1.8 and 0.2 episodes/1000 catheter days, respectively. Central line-associated bloodstream infection occurred at a rate of 3.3 episodes/1000 catheter days. Local central venous and arterial catheter infection occurred at 0.16 and 0.02 episodes/1000 catheter days, respectively. The difference in incidence between devices suspected of infection and those responsible for infection resulted in AUD$67,087 unnecessarily spent on device replacement. CONCLUSIONS: Unnecessary device removal due to suspected infection presents a substantial clinical problem which is costly for the healthcare organisation and time-consuming for clinicians and places the patient at an increased risk of iatrogenic complications. There is a need for robust evidence and clinical practice guidelines to inform clinical decision-making to reduce unnecessary device removal.

Polyhexamethylene biguanide discs versus unmedicated dressings for prevention of central venous catheter-associated infection in the intensive care unit: A pilot randomised controlled trial to assess protocol safety and feasibility.

BACKGROUND: Central venous catheters are prone to infectious complications, affecting morbidity, mortality and healthcare costs. Polyhexamethylene biguanide-impregnated discs at the catheter insertion site may prevent local and bloodstream infection; however, efficacy has not been established in a critical care setting. OBJECTIVE: The objective of this study was to pilot test polyhexamethylene biguanide-impregnated discs compared to standard unmedicated dressings for central venous catheter infection prevention in critically ill patients. METHODS: This was a single-centre pilot randomised controlled trial. Adults admitted to intensive care requiring a central venous catheter for >72 h were eligible. Patients with a current bloodstream infection, concurrent central venous catheter, chlorhexidine or polyhexamethylene biguanide allergy, or sensitive skin were excluded. Patients were randomised to receive standard central venous catheter dressings with/without polyhexamethylene biguanide discs. OUTCOME MEASURES: The primary outcome was feasibility, defined by patient eligibility, recruitment, retention, protocol adherence, missing data, and staff satisfaction. Secondary outcomes included: central line-associated infection; primary bloodstream infection; local infection; skin complications; device/dressing dwell time; serious adverse events, and cost-effectiveness. RESULTS: Of 309 patients screened, 80 participants were recruited with 98% (n = 78) receiving an internal jugular catheter which dwelled for a median of 5 days (interquartile range = 4.0, 6.0). Feasibility criteria were predominantly met (recruitment 88%; retention 100%; protocol fidelity 91%); however, eligibility criteria were not met (32%; most commonly owing to short predicted catheter dwell). Staff acceptability criteria were met, with 83% of staff scoring dressing application and removal ≥7 on a numerical rating scale. There were no central line-associated bloodstream infections and no local infections. Insertion site itch occurred in 4% (control [n = 0], intervention [n = 3]) of participants, while 32% (24/76) reported pain, and 46% (35/76) tenderness. CONCLUSIONS: Polyhexamethylene biguanide discs appear safe for central venous catheter infection prevention. Feasibility of a large efficacy trial was established with some modifications to screening processes. Large, adequately powered randomised controlled trials are needed to test the infection prevention hypotheses.

Inherent and modifiable risk factors for peripheral venous catheter failure during cancer treatment: a prospective cohort study.

PURPOSE: To identify modifiable and non-modifiable risk factors for peripheral intravenous catheter (PIV) failure among patients requiring intravenous treatment for oncology and haematology conditions. METHODS: A single-centre prospective cohort study was conducted between October 2017 and February 2019. Adult in-patients requiring a PIV for therapy were prospectively recruited from two cancer units at a tertiary hospital in Queensland, Australia. The primary outcome was a composite of complications leading to PIV failure (local and bloodstream infection; occlusion; infiltration/extravasation; leakage; dislodgement; and/or phlebitis). Secondary outcomes were (i) PIV dwell time; (ii) insertion and (iii) failure of a CVAD; (iv) adverse events; (v) length of hospital stay. Outcomes were investigated using Bayesian multivariable linear regression modelling and survival analysis. RESULTS: Of 200 participants, 396 PIVs were included. PIV failure incidence was 34.9%; the most common failure type was occlusion/infiltration (n = 74, 18.7%), then dislodgement (n = 33, 8.3%), and phlebitis (n = 30, 7.6%). While several patient and treatment risk factors were significant in univariable modelling, in the final multivariable model, only the use of non-sterile tape (external to the primary dressing) was significantly associated with decreased PIV dislodgement (hazard ratio 0.06, 95% confidence interval 0.01, 0.48; p = 0.008). CONCLUSION: PIV failure rates among patients receiving cancer treatment are high, the sequelae of which may include delayed treatment and infection. Larger studies on risk factors and interventions to prevent PIV failure in this population are needed; however, the use of secondary securements (such as non-sterile tape) to provide further securement to the primary PIV dressing is particularly important. TRIAL REGISTRATION: Study methods were registered prospectively with the Australian New Zealand Clinical Trials Registry on the 27th March 2017 (ACTRN12617000438358); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372191&isReview=true.