Emily Larsen

Infection risks associated with peripheral vascular catheters

Background: Peripheral vascular catheters (PVC) are the most frequently used invasive medical devices in hospitals, with 330 million sold each year in the USA alone. One in three UK inpatients at any one time has at least one PVC in situ according to the Scottish National Prevalence survey. Method: A narrative review of studies describing the infection risks associated with PVCs. Results: It is estimated that 30–80% of hospitalised patients receive at least one PVC during their hospital stay. Despite their prevalence, PVCs are not benign devices, and the high number of PVCs inserted annually has resulted in serious catheter-related bloodstream infections and significant morbidity, prolonged hospital stay and increased healthcare system costs. To date, PVC infections have been under-evaluated. Most studies focus on central venous catheter rather than PVC-associated bloodstream infections. Risks associated with PVC infection must be addressed to reduce patient morbidity and associated costs of prolonged hospital admission and treatment. Discussion: This article discusses the sources and routes of PVC-associated infection and outlines known effective prevention and intervention strategies.

Securing All intraVenous devices Effectively in hospitalised patients— the SAVE trial: study protocol for a multicentre randomised controlled trial

Introduction Over 70% of all hospital admissions have a peripheral intravenous device (PIV) inserted; however, the failure rate of PIVs is unacceptably high, with up to 69% of these devices failing before treatment is complete. Failure can be due to dislodgement, phlebitis, occlusion/infiltration and/or infection. This results in interrupted medical therapy; painful phlebitis and reinsertions; increased hospital length of stay, morbidity and mortality from infections; and wasted medical/nursing time. Appropriate PIV dressing and securement may prevent many cases of PIV failure, but little comparative data exist regarding the efficacy of various PIV dressing and securement methods. This trial will investigate the clinical and cost-effectiveness of 4 methods of PIV dressing and securement in preventing PIV failure. Methods and analysis A multicentre, parallel group, superiority randomised controlled trial with 4 arms, 3 experimental groups (tissue adhesive, bordered polyurethane dressing, sutureless securement device) and 1 control (standard polyurethane dressing) is planned. There will be a 3-year recruitment of 1708 adult patients, with allocation concealment until randomisation by a centralised web-based service. The primary outcome is PIV failure which includes any of: dislodgement, occlusion/infiltration, phlebitis and infection. Secondary outcomes include: types of PIV failure, PIV dwell time, costs, device colonisation, skin colonisation, patient and staff satisfaction. Relative incidence rates of device failure per 100 devices and per 1000 device days with 95% CIs will summarise the impact of each dressing, and test differences between groups. Kaplan-Meier survival curves (with log-rank Mantel-Cox test) will compare device failure over time. p Values of <0.05 will be considered significant. Secondary end points will be compared between groups using parametric or non-parametric techniques appropriate to level of measurement. Ethics and dissemination Ethical approval has been received from Queensland Health (HREC/11/QRCH/152) and Griffith University (NRS/46/11/HREC). Results will be published according to the CONSORT statement and presented at relevant conferences. Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN); 12611000769987.

Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients—a study protocol for a randomised controlled trial (The RSVP Trial)

Introduction Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. Methods and analysis This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant. Ethics and dissemination Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care. Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).

Observational Study of Peripheral Intravenous Catheter Outcomes in Adult Hospitalized Patients: A Multivariable Analysis of Peripheral Intravenous Catheter Failure

BACKGROUND: Almost 70% of hospitalized patients require a peripheral intravenous catheter (PIV), yet up to 69% of PIVs fail prior to completion of therapy. OBJECTIVE: To identify risk factors associated with PIV failure. DESIGN: A single center, prospective, cohort study. SETTING: Medical and surgical wards of a tertiary hospital located in Queensland, Australia. PARTICIPANTS: Adult patients requiring a PIV. MEASUREMENTS: Demographic, clinical, and potential PIV risk factors were collected. Failure occurred if the catheter had complications at removal. RESULTS: We recruited 1000 patients. Catheter failure occurred in 512 (32%) of 1578 PIVs. Occlusion/infiltration risk factors included intravenous (IV) flucloxacillin (hazard ratio [HR], 1.98; 95% confidence interval [CI], 1.19‐3.31), 22‐gauge PIVs (HR, 1.43; 95% CI, 1.02‐2.00), and female patients (HR, 1.48; 95% CI, 1.10‐2.00). Phlebitis was associated with female patients (HR, 1.81; 95% CI, 1.40‐2.35), bruised insertion sites (HR, 2.16; 95% CI, 1.26‐3.71), IV flucloxacillin (HR, 2.01; 95% CI, 1.26‐3.21), and dominant side insertion (HR, 1.39; 95% CI, 1.09‐1.77). Dislodgement risks were a paramedic insertion (HR, 1.78; 95% CI, 1.03‐3.06). Each increase by 1 in the average number of daily PIV accesses was associated (HR 1.11, 95% CI 1.03‐1.20)‐(HR 1.14, 95% CI 1.08‐1.21) with occlusion/infiltration, phlebitis and dislodgement. Additional securement products were associated with less (HR 0.32, 95% CI 0.22‐0.46)‐(HR 0.63, 95% CI 0.48‐0.82) occlusion/infiltration, phlebitis and dislodgement. CONCLUSION: Modifiable risk factors should inform education and inserter skill development to reduce the currently high rate of PIV failure.

Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial

BACKGROUND Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. METHODS We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. Patients, clinicians, and research staff were not masked because of the nature of the intervention, but infections were adjudicated by a physician who was masked to treatment allocation. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. FINDINGS Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 163 (38%) of 427 patients in the tissue adhesive with polyurethane group (absolute risk difference -4·5% [95% CI -11·1 to 2·1%], p=0·19), 169 (40%) of 423 of patients in the bordered polyurethane group (-2·7% [-9·3 to 3·9%] p=0·44), 176 (41%) of 425 patients in the securement device with poplyurethane group (-1·2% [-7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. INTERPRETATION Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. FUNDING Australian National Health and Medical Research Council.

Chlorhexidine gluconate or polyhexamethylene biguanide disc dressing to reduce the incidence of central-line-associated bloodstream infection: a feasibility randomized controlled trial (the CLABSI trial)

BACKGROUND A number of antimicrobial-impregnated discs to prevent central-line-associated bloodstream infection (CLABSI) are marketed but it is unclear which disc is most effective. AIM To investigate the feasibility and safety of comparing two antimicrobial-impregnated discs to prevent CLABSI. METHODS A single-centre, parallel group, randomized controlled trial was conducted in a 929-bed tertiary referral hospital. Hospital inpatients requiring a peripherally inserted central catheter were randomized to chlorhexidine gluconate (CHG) or polyhexamethylene biguanide (PHMB) disc dressing group. Dressings were replaced every seven days, or earlier, if clinically required. Participants were followed until device removal or hospital discharge. Feasibility outcomes included: proportion of potentially eligible participants who were enrolled; proportion of protocol violations; and proportion of patients lost to follow-up. Clinical outcomes were: CLABSI incidence, diagnosed by a blinded infection control practitioner; all-cause bloodstream infection (BSI); and product-related adverse events. FINDINGS Of 143 patients screened, 101 (71%) were eligible. Five (3.5%) declined participation. There was one post-randomization exclusion. Two (2%) protocol violations occurred in the CHG group. No patients were lost to follow-up. Three (3%) BSIs occurred; two (2%) were confirmed CLABSIs (one in each group) and one a mucosal barrier injury-related BSI. A total of 1217 device-days were studied, resulting in 1.64 CLABSIs per 1000 catheter-days. One (1%) disc-related adverse event occurred in the CHG group. CONCLUSION Disc dressings containing PHMB are safe to use for infection prevention at catheter insertion sites. An adequately powered trial to compare PHMB and CHG discs is feasible.

Insertion site assessment of peripherally inserted central catheters: Inter-observer agreement between nurses and inpatients:

Introduction: Many patients are discharged from hospital with a peripherally inserted central catheter in place. Monitoring the peripherally inserted central catheter insertion site for clinical and research purposes is important for identifying complications, but the extent to which patients can reliably report the condition of their catheter insertion site is uncertain. The aim of this study was to assess the inter-observer agreement between nurses and patients when assessing a peripherally inserted central catheter site. Methods: The study was based on inpatients who were enrolled in a single-centre, randomised controlled trial comparing four different dressing and securement devices for peripherally inserted central catheter sites. A seven-item peripherally inserted central catheter site assessment tool, containing questions about the condition of the dressing and the insertion site, was developed. Assessment was conducted once by the research nurse and, within a few minutes, independently by the patient. Proportions of agreement and Cohen’s kappa were calculated. Results: In total, 73 patients agreed to participate. Overall, percentage agreement ranged from 83% to 100% (kappa = .65–.82). For important clinical signs (redness, swelling, ooze, pus and tracking), there were high levels of percentage agreement (99%–100%). Conclusion: The high level of agreement between nurse/patient pairs make the instrument useful for assessing peripherally inserted central catheter–associated signs of localised infection, allergic or irritant dermatitis or dressing dislodgement in a community setting.

Integrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): a randomised controlled trial protocol

Introduction Peripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost–utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system. Methods and analysis Two-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections. Secondary outcomes: first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost–utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques. Ethics and dissemination Ethical approval from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/16/QRBW/527), Griffith University Human Research Ethics Committee (Ref No. 2017/002) and the South Metropolitan Health Services Human Research Ethics Committee (Ref No. 2016–239). Results will be published in peer-reviewed journals. Trial registration number ACTRN12617000089336.

Prophylactic insertion of large bore peripheral intravenous catheters in maternity patients for postpartum haemorrhage: A cohort study

Insertion of a 16 or 18 gauge peripheral intravenous catheter is a potentially painful intervention but one frequently experienced by pregnant women when admitted to hospital. Although the rationale for this practice is ‘in case of an emergency bleed’, evidence for using large‐bore catheters in this population is absent.

Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: The PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial

Introduction Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. Methods and analysis Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. Secondary outcomes: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant. Ethics and dissemination Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published. Trial registration Trial registration number is: ACTRN12616000315415.