Society for Healthcare Epidemiology of America Compendium updates 2022.

PURPOSE OF REVIEW: Healthcare-associated infections (HAIs) are a leading cause of preventable harm in US hospitals. Hospitals are required to conduct surveillance and report selected HAIs, including central line-associated bloodstream infections, catheter-associated urinary tract infections, colon and abdominal hysterectomy surgical-site infections, methicillin-resistant Staphylococcus aureus bacteremia, and Clostridioides difficile infections, to the CDC's National Healthcare Safety Network. RECENT FINDINGS: Up until the COVID-19 pandemic, there was significant progress in reducing HAIs. However, the pandemic resulted in extraordinary challenges for infection prevention in hospitals. Increases in HAIs were observed throughout 2020 and 2021. The Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals has recently been updated and provides common sense evidenced-based strategies to reduce HAIs. SUMMARY: The purpose of this review is to highlight important changes since the 2014 Compendium.

A Quality Improvement Initiative to Decrease Central Line-Associated Bloodstream Infections During the COVID-19 Pandemic: A "Zero Harm" Approach.

INTRODUCTION: Central line-associated bloodstream infections (CLABSIs) are associated with significant patient harm and health care costs. Central line-associated bloodstream infections are preventable through quality improvement initiatives. The COVID-19 pandemic has caused many challenges to these initiatives. Our community health system in Ontario, Canada, had a baseline rate of 4.62 per 1000 line days during the baseline period. OBJECTIVES: Our aim was to reduce CLABSIs by 25% by 2023. METHODS: An interprofessional quality aim committee performed a root cause analysis to identify areas for improvement. Change ideas included improving governance and accountability, education and training, standardizing insertion and maintenance processes, updating equipment, improving data and reporting, and creating a culture of safety. Interventions occurred over 4 Plan-Do-Study-Act cycles. The outcome was CLABSI rate per 1000 central lines: process measures were rate of central line insertion checklists used and central line capped lumens used, and balancing measure was the number of CLABSI readmissions to the critical care unit within 30 days. RESULTS: Central line-associated bloodstream infections decreased over 4 Plan-Do-Study-Act cycles from a baseline rate of 4.62 (July 2019-February 2020) to 2.34 (December 2021-May 2022) per 1000 line days (51%). The rate of central line insertion checklists used increased from 22.8% to 56.9%, and central line capped lumens used increased from 72% to 94.3%. Mean CLABSI readmissions within 30 days decreased from 1.49 to 0.1798. CONCLUSIONS: Our multidisciplinary quality improvement interventions reduced CLABSIs by 51% across a health system during the COVID-19 pandemic.

Health Care-Associated Infections in Older Adults: Epidemiology and Prevention.

Health care-associated infections (HAIs) are a global public health threat, which disproportionately impact older adults. Host factors including aging-related changes, comorbidities, and geriatric syndromes, such as dementia and frailty, predispose older individuals to infection. The HAI risks from medical interventions such as device use, antibiotic use, and lapses in infection control follow older adults as they transfer among a network of interrelated acute and long-term care facilities. Long-term care facilities are caring for patients with increasingly complex needs, and the home-like communal environment of long-term care facilities creates distinct infection prevention challenges.

Salvage of infected tunneled hemodialysis catheters using 70% ethanol lock solution: A brief report.

Tunneled hemodialysis catheters are the lifeline to patients on maintenance hemodialysis with failed arteriovenous fistulas. However, thrombosis and infection are the main causes of reduced longevity of these accesses. According to IDSA guidelines, catheter-related infection with Pseudomonas and fungi are absolute indications for catheter removal. Considering the cost and difficulties in catheter replacement, for those in whom all accesses are exhausted, retaining the same catheter may be lifesaving. We would like to present two patients in whom, 70% ethanol instillation was used to eradicate infection with these organisms as confirmed by repeat cultures post procedure. Hemodialysis is being successfully continued through the same catheter.

Emergent themes from a quality improvement programme for CLABSI/CAUTI prevention in ICUs amid the COVID-19 pandemic.

OBJECTIVES: Healthcare-associated infection (HAI) prevention has been difficult for healthcare providers to maintain during the COVID-19 pandemic. This study summarises themes for maintaining infection prevention activities learnt from the implementation of a quality improvement (QI) programme during the pandemic. METHODS: We conducted qualitative analysis of participants' semistructured exit interviews, self-assessments on HAI prevention activities, participant-created action plans, chat-box discussions during webinars and informal correspondence. SETTING: Intensive care units (ICUs) with elevated rates of central line-associated bloodstream infections (CLABSI) and/or catheter-associated urinary tract infections (CAUTI) participating in the Agency for Healthcare Research and Quality Safety Programme for ICUs: Preventing CLABSI and CAUTI. RESULTS: Forty-nine ICU teams who participated in the programme between December 2019 and April 2021 found ways to maintain activities such as daily huddles, multidisciplinary rounds, and central line and indwelling urinary catheter monitoring despite barriers, including staff turnover, a lack of time, staff fatigue and pandemic-related guidelines limiting providers' time around patients. We use four themes to summarise the ICU teams' adaptations that allowed them to sustain infection prevention activities: (1) Units had CLABSI and CAUTI prevention teams, policies and practices established prior to the pandemic; (2) Units were flexible in their implementation of those policies and practices; (3) Units maintained consistent buy-in for and engagement in HAI prevention activities among both leadership and care teams throughout the pandemic and (4) Units looked to learn from other units in their facility and beyond. CONCLUSIONS: Future shocks such as the pandemic must be anticipated, and the healthcare system must be resilient to the resulting disruptions to HAI prevention activities. This study encountered four themes for successful maintenance of infection prevention activities during the current pandemic: the value of a pre-existing infection prevention infrastructure; a flexibility in approach; broad buy-in for maintaining QI programmes and the facilitation of idea-sharing.

Healthcare-associated infection prevention and control practices in Israel: results of a national survey.

BACKGROUND: Healthcare-associated infection (HAI) is a common and largely preventable cause of morbidity and mortality. The COVID-19 pandemic has presented unprecedented challenges to health systems. We conducted a national survey to ascertain hospital characteristics and the use of HAI prevention measures in Israel. METHODS: We e-mailed surveys to infection prevention and control (IPC) leads of acute care hospitals in Israel. The survey included questions about the use of practices to prevent catheter-associated urinary tract infection (CAUTI), central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP), and Clostridioides difficile infection (CDI). The survey also assessed COVID-19 impact and healthcare worker well-being. RESULTS: IPC leads from 15 of 24 invited hospitals (63%) completed the survey. Only one-third of respondents reported strong support for IPC from hospital leadership. Although several prevention practices were used by all hospitals (e.g., maximum sterile barrier precautions for CLABSI and real-time assessment of environmental cleaning for CDI), use of other practices was suboptimal-particularly for CAUTI and VAP. COVID-19 had a profound impact on Israeli hospitals, with all hospitals reporting opening of new units to care for COVID patients and most reporting moderate to extreme financial hardship. All hospitals reported highly successful plans to vaccinate all staff and felt confident that the vaccine is safe and effective. CONCLUSION: We provide a status report of the IPC characteristics and practices Israeli hospitals are currently using to prevent HAIs during the COVID-19 era. While many globally accepted IPC practices are widely implemented, opportunities to increase the use of certain IPC practices in Israeli hospitals exist.

Complications of peripherally inserted central catheters in adult hospitalized patients and outpatients in the KTFIXPICC study: A randomized controlled trial evaluating a fixation device KT FIX Plussystem.

BACKGROUND: Poor securement potentiates Peripherally inserted central catheters (PICC) complications. A dressing device (KT FIX Plus) offers stronger skin attachment, which may reduce the risk of dressing disruption. We aimed to evaluate this device. METHODS: We conducted a single-center parallel-group open-label randomized controlled trial. Hospitalized and outpatient consecutive adults requiring PICCs were randomized to KT FIX Plus or standard of care (SOC). The primary endpoint was the composite of PICC-associated complications until removal, including occlusion, migration, accidental withdrawal, infection, thrombosis, and hematoma. RESULTS: No statistically significant difference was observed in terms of complications: 67 (35%) in the KT FIX Plus group vs 36 (37%) in the SOC group (log-rank P = 0.76). In multivariate Cox analysis, independent risk factors for PICC-associated complications were obesity (adjusted hazard ratio (aHR), 1.08, P < .001) and diabetes (aHR, 1.85, P = .039), adjusting for chronic renal failure, number of lumens, catheter/vein diameter ratio and duration of home-based care. Multiple lumen catheters increased the risk of accidental withdrawal and migration (HR, 2.4, P = .008). CONCLUSIONS: In our study, the use of KT FIX Plus did not reduce the risk of complications adjusting for other risk factors such as obesity and diabetes. The number of catheter lumens is one of the modifiable factors to reduce complications. Further studies are required to find the best securement and dressing system.

A collaborative approach intended to reduce the duration of short term urinary catheters in adult patients at a tertiary care medical center also significantly reduced the duration of hospitalization.

BACKGROUND: Urinary tract infections are the leading cause of nosocomial infections in the United States. The major contributing factor is the placement of indwelling urinary catheters. METHODS: Following a chart review of adult patients hospitalized at a tertiary care medical center who required the use of a short-term (≤ 2 weeks) indwelling urinary catheter, a collaborative effort was initiated by an Infectious Diseases physician to develop protocols focused on the clinical service involved for the expeditious removal of short-term indwelling urinary catheters. The protocols relied in part on the standards of practice by pertinent medical/surgical subspecialty societies. Usage of urinary catheters and duration of hospitalization following implementation of the protocols was assessed. RESULTS: Based on a multivariate analysis controlling for demographic variables, comorbidities, medical vs surgical service, and indication for the urinary catheterization, the median duration of catheterization was significantly reduced from 6.7 days to 3.6 days after the protocols were initiated (P < .001), and the median duration of hospitalization was significantly reduced from 9.5 days to 5.9 days (P < .001). No patient had to have the urinary catheter reinserted. CONCLUSIONS: Development of collaborative protocols for the removal of short-term indwelling urinary catheters significantly reduced both the duration of catheterization and the duration of hospitalization.

Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis.

BACKGROUND: Patients with kidney failure require vascular access to receive maintenance haemodialysis (HD), which can be achieved by an arteriovenous fistula or a central venous catheter (CVC). CVC use is related to frequent complications such as venous stenosis and infection. Venous stenosis occurs mainly due to trauma caused by the entrance of the catheter into the venous lumen and repeated contact with the vein wall.  A biofilm, a colony of irreversible adherent and self-sufficient micro-organisms embedded in a self-produced matrix of exopolysaccharides, is associated with the development of infections in patients with indwelling catheters. Despite its clinical relevance, the treatment of catheter-related bloodstream infections (CRBSIs) in patients receiving maintenance HD remains controversial, especially regarding catheter management. Antibiotic lock solutions may sterilise the catheter, treat the infection and prevent unnecessary catheter procedures. However, such treatment may also lead to antibiotic resistance or even clinical worsening in certain more virulent pathogens. Catheter removal and delayed replacement may remove the source of infection, improving infectious outcomes, but this approach may also increase vascular access stenosis, thrombosis or both, or even central vein access failure. Catheter guidewire exchange attempts to remove the source of infection while maintaining access to the same vein and, therefore, may improve clinical outcomes and preserve central veins for future access. OBJECTIVES: To assess the benefits and harms of different interventions for CRBSI treatment in patients receiving maintenance HD through a permanent CVC, such as systemic antibiotics alone or systemic antibiotics combined with either lock solutions or catheter guidewire exchange or catheter replacement. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 21 December 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) and quasi-RCTs evaluating the management of CRBSI in permanent CVCs in people receiving maintenance HD. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, assessed their risk of bias, and performed data extraction. Results were expressed as risk ratios (RR) or hazard ratios (HR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with their 95% confidence intervals (CI). The certainty of the evidence was assessed using GRADE. MAIN RESULTS: We identified two RCTs and one quasi-RCT that enrolled 760 participants addressing the treatment of CRBSIs in people (children and adults) receiving maintenance HD through CVC. No two studies compared the same interventions. The quasi-RCT compared two different lock solutions (tissue plasminogen activator (TPA) and heparin) with concurrent systemic antibiotics. One RCT compared systemic antibiotics alone and in association with an ethanol lock solution, and the other compared systemic antibiotics with different catheter management strategies (guidewire exchange versus removal and replacement). The overall certainty of the evidence was downgraded due to the small number of participants, high risk of bias in many domains, especially randomisation, allocation, and other sources of bias, and missing outcome data. It is uncertain whether an ethanol lock solution used with concurrent systemic antibiotics improved CRBSI eradication compared to systemic antibiotics alone (RR 1.61, 95% CI 1.16 to 2.23) because the certainty of this evidence is very low. There were no reported differences between the effects of TPA and heparin lock solutions on cure rates (RR 0.92, 95% CI 0.74 to 1.15) or between catheter guidewire exchange versus catheter removal with delayed replacement, expressed as catheter infection-free survival (HR 0.88, 95% CI 0.43 to 1.79). To date, no results are available comparing other interventions. Outcomes such as venous stenosis and/or thrombosis, antibiotic resistance, death, and adverse events were not reported. AUTHORS' CONCLUSIONS: Currently, there is no available high certainty evidence to support one treatment over another for CRBSIs. The benefit of using ethanol lock treatment in combination with systemic antibiotics compared to systemic antibiotics alone for CRBSIs in patients receiving maintenance HD remains uncertain due to the very low certainty of the evidence. Hence, further RCTs to identify the benefits and harms of CRBSI treatment options are needed. Future studies should unify CRBSI and cure definitions and improve methodological design.

CLABSI Rounding Team: A Collaborative Approach to Prevention.

BACKGROUND: Central line-associated bloodstream infections (CLABSIs) are an ongoing concern in health care, resulting in increased mortality, morbidity, length of stay, and additional costs to hospitals. LOCAL PROBLEM: Despite intermittent improvements in CLABSI rates within our facility, long-term sustainment has been challenging. METHODS: This was a quality improvement project including a collaborative rounding approach supported by specialty nursing roles. INTERVENTIONS: In addition to implementing a variety of evidence-based interventions, the rounding team performed audits to assess performance and created focused education tools to address the identified opportunities within each individual unit. RESULTS: High levels of engagement as evidenced by increased audit completion resulted in CLABSI reductions. However, 2 peaks in CLABSI rates were associated with higher volumes of coronavirus disease (COVID-19) hospitalizations and decreased audits. CONCLUSIONS: Despite challenges correlated with COVID-19, a collaborative rounding team promotes and enhances awareness of prevention methods and a culture of safety.

Status of hospital infection prevention practices in Thailand in the era of COVID-19: Results from a national survey.

BACKGROUND: A 2014 study assessed infection prevention (IP) practices in Thai hospitals for catheter-associated urinary tract infection (CAUTI), central line-associated bloodstream infection (CLABSI), and ventilator-associated pneumonia (VAP). This study compares current IP practices to results obtained in 2014. METHODS: Between February 1, 2021 and August 31, 2021, we resurveyed Thai hospitals regarding practices to prevent CAUTI, CLABSI, and VAP. We also assessed COVID-19 impact and healthcare worker burnout and coping strategies. We distributed 100 surveys to a convenience sample of infection preventionists. RESULTS: Response rate: 100%. One-third (31%) of hospitals reported excellent leadership support for infection control (ie, responses of "good" or "excellent" to one survey question). Some prevention practices increased between 2014 vs 2021 (CAUTI: catheter reminder/stop-order/nurse-initiated discontinuation [50.0% vs 70.0%, P < .001]; condom catheters [36.3% vs 51.0%, P = .01]; ultrasound bladder scanner [4.7% vs 12.0%, P = .03]; CLABSI: chlorhexidine gluconate insertion site antisepsis [73.6% vs 85.0%, P = .03]; maximum sterile barrier precautions [63.2% vs 80.0%, P = .003]; VAP: selective digestive tract decontamination [26.9% vs 40.0%, P = .02]). Antimicrobial catheter use decreased since 2014 (10.4% vs 3.0%, P < .001). Many other practices remain suboptimal. COVID-19 challenges: staff shortages (71%), financial hardships (67%). Only 46% of infection preventionists felt safe working during COVID-19. CONCLUSIONS: More national strategic support is needed for IP programs to prevent CAUTI, CLABSI, VAP and healthcare worker well-being in Thailand during the COVID-19 pandemic.

Evaluation of the safety of a novel peripheral vasopressor pilot program and the impact on central line placement in medical and surgical intensive care units.

PURPOSE: The purpose of this quality improvement project was to evaluate the safety and feasibility of peripheral vasopressor administration in an attempt to minimize the placement and improve early removal of unnecessary central lines to reduce central line-associated bloodstream infection (CLABSI) rates. METHODS: A retrospective chart review was conducted on patients who received vasopressors via peripheral infusion over 3 months, starting at the time of guideline implementation. RESULTS: We identified 129 vasopressor orders among 79 patients that were administered peripherally. Among these orders, 3 events were documented as possible extravasation events. Forty-five patients (57%) did not require central line placement due to increasing vasopressor requirements. Standard utilization ratio data suggest minimal central line impact of the protocol implementation. December 2020 to February 2021 was associated with a large second peak of coronavirus disease 2019 (COVID-19) in our region. Utilization of central lines was less than predicted in December 2020 to February 2021 in 2 of our 3 intensive care units (ICUs); however, the differences were statistically significant on only 3 occasions. In the third ICU, utilization was greater than predicted, but this unit housed a majority of the most critically ill patients with COVID-19. CONCLUSION: This study suggests that short-term use of select vasopressors at conservative doses is safe for peripheral administration and points toward efficacy at preventing central line placement. Further analysis is required to confirm efficacy.

The downstream effects of the COVID-19 pandemic: The supply chain failure, a wicked problem.

The failure of the global supply chain became rapidly apparent at the beginning of the COVID-19 pandemic when healthcare organizations were left without supplies needed to care for patients. The supply chain failure is one downstream effect of the pandemic and indirectly impacts patient morbidity and mortality. This column presents a case study of one staff nurse's experience working in a pediatric intensive care unit at a rural children's hospital two years into the pandemic and the toll the global supply chain failure continues to take on patients and healthcare professionals. Central Line Blood Stream Infections (CLABSIs) are used to showcase the severity of the supply chain failure at the point of care. Standardized central line insertion and care bundles have proven to be effective in reducing the incidence of CLABSI; however, they are dependent on the availability of materials and supplies. Health care providers face a "wicked problem" in preventing CLABSIs. The failure of the global supply chain must be examined by healthcare organizations, manufacturers, and government officials so that new systems can be put into place, so we are prepared for a public health emergency.

Impact of COVID-19 on hospital acquired infections.

While there are established and effective guidelines for prevention of hospital-acquired infections (HAIs), the impact of the COVID-19 pandemic on those implemented practices and policies have not been thoroughly investigated. This report examines the impact of COVID-19 on HAI rates at 2 hospitals within the same healthcare system. HAIs significantly increased during the COVID-19 pandemic which correlated with the use of overtime and agency nursing hours.

The Impact of Coronavirus Disease 2019 (COVID-19) on Healthcare-Associated Infections.

BACKGROUND: The profound changes wrought by coronavirus disease 2019 (COVID-19) on routine hospital operations may have influenced performance on hospital measures, including healthcare-associated infections (HAIs). We aimed to evaluate the association between COVID-19 surges and HAI and cluster rates. METHODS: In 148 HCA Healthcare-affiliated hospitals, from 1 March 2020 to 30 September 2020, and a subset of hospitals with microbiology and cluster data through 31 December 2020, we evaluated the association between COVID-19 surges and HAIs, hospital-onset pathogens, and cluster rates using negative binomial mixed models. To account for local variation in COVID-19 pandemic surge timing, we included the number of discharges with a laboratory-confirmed COVID-19 diagnosis per staffed bed per month. RESULTS: Central line-associated blood stream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia increased as COVID-19 burden increased. There were 60% (95% confidence interval [CI]: 23-108%) more CLABSI, 43% (95% CI: 8-90%) more CAUTI, and 44% (95% CI: 10-88%) more cases of MRSA bacteremia than expected over 7 months based on predicted HAIs had there not been COVID-19 cases. Clostridioides difficile infection was not significantly associated with COVID-19 burden. Microbiology data from 81 of the hospitals corroborated the findings. Notably, rates of hospital-onset bloodstream infections and multidrug resistant organisms, including MRSA, vancomycin-resistant enterococcus, and Gram-negative organisms, were each significantly associated with COVID-19 surges. Finally, clusters of hospital-onset pathogens increased as the COVID-19 burden increased. CONCLUSIONS: COVID-19 surges adversely impact HAI rates and clusters of infections within hospitals, emphasizing the need for balancing COVID-related demands with routine hospital infection prevention.

Catheter-Associated Bloodstream Infections among Patients on Hemodialysis: Progress before and during the COVID-19 Pandemic.

Measures implemented to prevent transmission of severe acute respiratory syndrome coronavirus 2 in outpatient dialysis facilities may also help to prevent catheter-associated bloodstream infections in patients receiving hemodialysis. We used United States Renal Data System data to examine rates of antibiotic administration within dialysis facilities and rates of hospital admission for catheter-associated bloodstream infection from March 2018 through November 2020, and rates of hospitalization for sepsis, to address overall changes in hospitalization during the coronavirus disease 2019 (COVID-19) pandemic. Using logistic regression, we estimated year-over-year adjusted odds ratios of these events in 3-month intervals. During the first 6 months of the pandemic, rates of antibiotic administration were between 20% and 21% lower, and rates of hospitalization for catheter-associated bloodstream infection were between 17% and 24% lower than during corresponding periods in 2019, without significant changes in rates of hospitalization for sepsis. However, rates of catheter-associated events also decreased between 2018 and 2019, driven by reductions in facilities operated by a large dialysis provider. These data suggest that significant reductions in catheter-associated infections occurred during the pandemic, superimposed on nonpandemic-related reductions in some facilities before the pandemic. Even after the pandemic, it may be prudent to continue some COVID-19 mitigation measures to prevent catheter-associated bloodstream infections.

Prevention of Central-Line Associated Bloodstream Infections: 2021 Update.

Despite a large volume of research in prevention, central line-associated bloodstream infections and catheter-related bloodstream infections continue to cause significant morbidity, mortality, and increased health care costs. Strategies in prevention, including decision about catheter placement, insertion bundles, adherence to standard of care guidelines, and technologic innovations, shown to decrease rates of catheter-related bloodstream infections and central line-associated bloodstream infections are described in this update. The coronavirus disease 2019 pandemic has resulted in increased health care-acquired infections, including central line-associated bloodstream infections.

Implementation of evidence-based strategies to reduce catheter-associated urinary tract infections among hospitalized, post-surgical adults.

Several catheter-associated urinary tract infection (CAUTI) prevention interventions were successfully implemented and evaluated on a surgical unit in a community-based hospital. Sustainability of CAUTI prevention efforts requires daily communication between multidisciplinary staff. In our hospital, daily report on CAUTI events and indwelling catheters at a hospital-wide, multidisciplinary safety huddle contributed to an enhanced focus on CAUTI-prevention strategies and unit-level reduction in device use days and CAUTI rates.

Implementation of an external female urinary catheter as an alternative to an indwelling urinary catheter.

BACKGROUND: Until recently, there has been a lack of viable alternative to an indwelling urinary catheter for female patients that require precise urine output measurements. With the introduction of external female urinary catheters, we can now substitute this type of device for an indwelling urinary catheter in many patients, decreasing their risk of catheter-associated urinary tract infections. METHODS: In this retrospective study, we analyzed the impact of a hospital-wide implementation of an external female urinary catheter at a large academic medical center. The study included female patients, greater than 18 years of age. We compared a 12-month period before and after device implementation to assess the impact on indwelling urinary catheter utilization and catheter-associated urinary tract infections rate. RESULTS: Data included over 220,000 patient days, over 10,000 external urinary catheter days and 33,000 indwelling urinary catheter days. We found a statistically significant decrease in indwelling urinary catheter utilization following the implementation of the external female urinary catheter, but only in intensive care units. CONCLUSIONS: It is our recommendation that facilities first implement the device in ICUs as this level of care was where we observed the most significant impact.

Peripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol.

INTRODUCTION: Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications. METHODS AND ANALYSIS: A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure, a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI. ETHICS AND DISSEMINATION: Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published. TRIAL REGISTRATION NUMBER: ACTRN12619000022167.