Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial).

INTRODUCTION: Peripheral intravenous catheters (PIVCs) are the most commonly used vascular access device in hospitalised patients. Yet PIVCs may be complicated by local or systemic infections leading to increased healthcare costs. Chlorhexidine gluconate (CHG)-impregnated dressings may help reduce PIVC-related infectious complications but have not yet been evaluated. We hypothesise an impregnated CHG transparent dressing, in comparison to standard polyurethane dressing, will be safe, effective and cost-effective in protecting against PIVC-related infectious complications and phlebitis. METHODS AND ANALYSIS: The ProP trial is a multicentre, superiority, randomised clinical and cost-effectiveness trial with internal pilot, conducted across three centres in Australia and France. Patients (adults and children aged ≥6 years) requiring one PIVC for ≥48 hours are eligible. We will exclude patients with emergent PIVCs, known CHG allergy, skin injury at site of insertion or previous trial enrolment. Patients will be randomised to 3M Tegaderm Antimicrobial IV Advanced Securement dressing or standard care group. For the internal pilot, 300 patients will be enrolled to test protocol feasibility (eligibility, recruitment, retention, protocol fidelity, missing data and satisfaction of participants and staff), primary endpoint for internal pilot, assessed by independent data safety monitoring committee. Clinical outcomes will not be reviewed. Following feasibility assessment, the remaining 2624 (1312 per trial arm) patients will be enrolled following the same methods. The primary endpoint is a composite of catheter-related infectious complications and phlebitis. Recruitment began on 3 May 2023. ETHICS AND DISSEMINATION: The protocol was approved by Ouest I ethic committee in France and by The Queensland Children's Hospital Human Research Ethics Committee in Australia. The findings will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05741866.

Implementation contexts and strategies for alternative peripherally inserted central catheter material and design selection: A qualitative exploration using CFIR/ERIC approach.

AIM: To explore the implementation contexts and strategies that influence the uptake and selection of alternative peripherally inserted central catheter (PICC) materials and design. DESIGN: Qualitative evaluation of end user perspectives within a randomized control trial of different PICC materials and design. METHODS: Semi-structured interviews with key stakeholders were undertaken via an adapted, rapid-analytic approach using the Consolidated Framework for Implementation Research. Outcomes were mapped against the Expert Recommendations for Implementing Change (ERIC) tool for strategies to guide innovation in PICC practice. RESULTS: Participants (n = 23) represented a combination of users and inserters/purchasers, from adult and paediatric settings. Dominant themes included intervention characteristics (intervention source), inner setting (structural characteristics) and individuals involved (self-efficacy). Strategies emerging to support a change from ERIC mapping (n = 16) included promotion of intervention adaptability, inclusion of staff and consumer perspectives and sufficient funding. Implementation contexts such as inner setting and individuals involved equally impacted PICC success and implementation effectiveness and enabled a greater understanding of barriers and facilitators to intervention implementation in this trial. CONCLUSION: Trial evidence is important, but healthcare decision-making requires consideration of local contexts especially resourcing. Implementation contexts for Australian healthcare settings include a practical, strategic toolkit for the implementation of alternative PICC materials and designs. REPORTING METHOD: This study adhered to COREQ guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Preventing adverse events during paediatric cancer treatment: protocol for a multi-site hybrid randomised controlled trial of catheter lock solutions (the CLOCK trial).

INTRODUCTION: Central venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock. METHODS AND ANALYSIS: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers. ETHICS AND DISSEMINATION: Ethics approval has been provided by Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000499785.

Securement to Prevent Noncuffed Central Venous Catheter Dislodgement in Pediatrics: The SECURED Superiority Randomized Clinical Trial.

Importance: Catheter dislodgement is a common complication for children with tunneled or peripherally inserted noncuffed central venous catheters (CVCs). A subcutaneous anchor securement system (SASS) may reduce this risk compared with traditional adhesive securement. Objective: To compare dislodgement of noncuffed CVCs secured with SASS with dislodgement of noncuffed CVCs secured with sutureless securement devices (SSDs). Design, Setting, and Participants: The SECURED (Securing Central Venous Catheters to Prevent Dislodegment) trial was a pragmatic, multicenter, superiority randomized clinical trial with an internal pilot and was conducted from August 5, 2020, to August 30, 2022, at 2 Australian quaternary pediatric hospitals. Data analysis was performed in January 2023. Patients aged 0 to 18 years requiring a noncuffed CVC (≥3F catheter) were eligible for inclusion. Follow-up duration was 8 weeks or until device removal. Interventions: Patients were randomly assigned 1:1 to receive an SASS or SSD, stratified by hospital and catheter type. Only 1 catheter was studied per patient. Main Outcomes and Measures: The primary outcome was dislodgement (partial or total), defined as movement of the catheter tip by greater than 1 cm (change in external catheter length) at any point during catheter dwell. Dislodgement, reported as a risk ratio (RR), was estimated using a generalized linear model with binomial family and log link. Secondary outcomes were reported as incidence rate ratios and were analyzed using Poission regression. Outcomes reported as mean differences (MDs) were analyzed using linear regression. Results: Of 310 randomized patients, 175 patients (56.5%) were male and median (IQR) patient age was 48 (16-120) months. A total of 307 patients had a catheter device inserted, of which 153 (49.8%) were SASS and 154 (50.2%) were SSD, and were included in the intention-to-treat (ITT) analysis. Device dislodgement was lower with SASS (8 dislodgements in 153 patients [5.2%]) compared with SSD (35 dislodgements in 154 patients [22.7%]) (RR, 0.23; 95% CI, 0.11-0.48; P < .001). The per-protocol analysis was consistent with the ITT analysis. Partial dislodgement accounted for most dislodgement events, including 6 partial dislodgements in the SASS group (3.9%) and 30 partial dislodgements in the SSD group (19.5%) (RR, 0.18; 95% CI, 0.08-0.42). This contributed to fewer complications during dwell in the SASS group (37 reported complications [24.2%]) vs the SSD group (60 reported complications [39.0%]) (RR, 0.62; 95% CI, 0.44-0.87). Staff reported greater difficulty removing devices anchored with SASS vs SSD (mean [SD], 29.1 [31.3] vs 5.3 [17.0], respectively; MD, 23.8; 95% CI, 16.7-31.0). However, use of SASS resulted in reduced per-participant health care costs of A$36.60 (95% credible interval, 4.25-68.95; US $24.36; 95% credible interval, 2.83-45.89). Conclusions and Relevance: In the SECURED trial, noncuffed CVCs secured with SASS had fewer dislodgements compared with SSDs, with a lower cost per patient and an acceptable safety profile. Future efforts should be directed at SASS implementation at the health service level. Trial Registration: anzctr.org.au Identifier: ACTRN12620000783921.

Peripherally inserted central catheter design and material for reducing catheter failure and complications.

BACKGROUND: Peripherally inserted central catheters (PICCs) facilitate diagnostic and therapeutic interventions in health care. PICCs can fail due to infective and non-infective complications, which PICC materials and design may contribute to, leading to negative sequelae for patients and healthcare systems. OBJECTIVES: To assess the effectiveness of PICC material and design in reducing catheter failure and complications. SEARCH METHODS: The University of Queensland and Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the WHO ICTRP and ClinicalTrials.gov trials registers to 16 May 2023. We aimed to identify other potentially eligible trials or ancillary publications by searching the reference lists of retrieved included trials, as well as relevant systematic reviews, meta-analyses, and health technology assessment reports. We contacted experts in the field to ascertain additional relevant information. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating PICC design and materials. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were venous thromboembolism (VTE), PICC-associated bloodstream infection (BSI), occlusion, and all-cause mortality. Secondary outcomes were catheter failure, PICC-related BSI, catheter breakage, PICC dwell time, and safety endpoints. We assessed the certainty of evidence using GRADE. MAIN RESULTS: We included 12 RCTs involving approximately 2913 participants (one multi-arm study). All studies except one had a high risk of bias in one or more risk of bias domain. Integrated valve technology compared to no valve technology for peripherally inserted central catheter design Integrated valve technology may make little or no difference to VTE risk when compared with PICCs with no valve (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.19 to 2.63; I² = 0%; 3 studies; 437 participants; low certainty evidence). We are uncertain whether integrated valve technology reduces PICC-associated BSI risk, as the certainty of the evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Integrated valve technology may make little or no difference to occlusion risk when compared with PICCs with no valve (RR 0.86, 95% CI 0.53 to 1.38; I² = 0%; 5 studies; 900 participants; low certainty evidence). We are uncertain whether use of integrated valve technology reduces all-cause mortality risk, as the certainty of evidence is very low (RR 0.85, 95% CI 0.44 to 1.64; I² = 0%; 2 studies; 473 participants). Integrated valve technology may make little or no difference to catheter failure risk when compared with PICCs with no valve (RR 0.80, 95% CI 0.62 to 1.03; I² = 0%; 4 studies; 720 participants; low certainty evidence). We are uncertain whether integrated-valve technology reduces PICC-related BSI risk (RR 0.51, 95% CI 0.19 to 1.32; I² = not applicable; 2 studies (no events in 1 study); 542 participants) or catheter breakage, as the certainty of evidence is very low (RR 1.05, 95% CI 0.22 to 5.06; I² = 20%; 4 studies; 799 participants). Anti-thrombogenic surface modification compared to no anti-thrombogenic surface modification for peripherally inserted central catheter design We are uncertain whether use of anti-thrombogenic surface modified catheters reduces risk of VTE (RR 0.67, 95% CI 0.13 to 3.54; I² = 15%; 2 studies; 257 participants) or PICC-associated BSI, as the certainty of evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces occlusion (RR 0.69, 95% CI 0.04 to 11.22; I² = 70%; 2 studies; 257 participants) or all-cause mortality risk, as the certainty of evidence is very low (RR 0.49, 95% CI 0.05 to 5.26; I² = not applicable; 1 study; 111 participants). Use of anti-thrombogenic surface modified catheters may make little or no difference to risk of catheter failure (RR 0.76, 95% CI 0.37 to 1.54; I² = 46%; 2 studies; 257 participants; low certainty evidence). No PICC-related BSIs were reported in one study (111 participants). As such, we are uncertain whether use of anti-thrombogenic surface modified catheters reduces PICC-related BSI risk (RR not estimable; I² = not applicable; very low certainty evidence). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces the risk of catheter breakage, as the certainty of evidence is very low (RR 0.15, 95% CI 0.01 to 2.79; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Antimicrobial impregnation compared to non-antimicrobial impregnation for peripherally inserted central catheter design We are uncertain whether use of antimicrobial-impregnated catheters reduces VTE risk (RR 0.54, 95% CI 0.05 to 5.88; I² = not applicable; 1 study; 167 participants) or PICC-associated BSI risk, as the certainty of evidence is very low (RR 2.17, 95% CI 0.20 to 23.53; I² = not applicable; 1 study; 167 participants). Antimicrobial-impregnated catheters probably make little or no difference to occlusion risk (RR 1.00, 95% CI 0.57 to 1.74; I² = 0%; 2 studies; 1025 participants; moderate certainty evidence) or all-cause mortality (RR 1.12, 95% CI 0.71 to 1.75; I² = 0%; 2 studies; 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter failure (RR 1.04, 95% CI 0.82 to 1.30; I² = not applicable; 1 study; 221 participants; low certainty evidence). Antimicrobial-impregnated catheters probably make little or no difference to PICC-related BSI risk (RR 1.05, 95% CI 0.71 to 1.55; I² = not applicable; 2 studies (no events in 1 study); 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter breakage (RR 0.86, 95% CI 0.19 to 3.83; I² = not applicable; 1 study; 804 participants; low certainty evidence). AUTHORS' CONCLUSIONS: There is limited high-quality RCT evidence available to inform clinician decision-making for PICC materials and design. Limitations of the current evidence include small sample sizes, infrequent events, and risk of bias. There may be little to no difference in the risk of VTE, PICC-associated BSI, occlusion, or mortality across PICC materials and designs. Further rigorous RCTs are needed to reduce uncertainty.

Use of central venous access devices outside of the pediatric intensive care units.

BACKGROUND: Central venous access devices (CVAD) are associated with central line associated bloodstream infection (CLABSI) and venous thromboembolism (VTE). We identified trends in non-intensive care unit (ICU) CVAD utilization, described complication rates, and compared resources between low and high CVAD sites. METHODS: We combined data from the Pediatric Health Information System (PHIS) database and surveys from included hospitals. We analyzed 10-year trends in CVAD encounters for non-ICU children between 01/2012-12/2021 and described variation and complication rates between 01/2017-12/2021. Using Fisher's exact test, we compared resources between low and high CVAD users. RESULTS: CVAD use decreased from 6.3% to 3.8% of hospitalizations over 10 years. From 2017-2021, 67,830 encounters with CVAD were identified. Median age was 7 (IQR 2-13) years; 46% were female. Significant variation in CVAD utilization exists (range 1.4-16.9%). Rates of CLABSI and VTE were 4.0% and 3.4%, respectively. Survey responses from 33/41 (80%) hospitals showed 91% had vascular access teams, 30% used vascular access selection guides, and 70% used midline/long peripheral catheters. Low CVAD users were more likely to have a team guiding device selection (100% vs 43%, p = 0.026). CONCLUSIONS: CVAD utilization decreased over time. Significant variation in CVAD use remains and may be associated with hospital resources. IMPACT: Central venous access device (CVAD) use outside of the ICU is trending down; however, significant variation exists between institutions. Children with CVADs hospitalized on the acute care units had a CLABSI rate of 4% and VTE rate of 3.4%. 91% of surveyed institutions have a vascular access team; however, the services provided vary between institutions. Even though 70% of the surveyed institutions have the ability to place midline/long peripheral catheters, the majority use these catheters less than a few times per month. Institutions with low CVAD use are more likely to have a vascular access team that guides device selection.

Implementation frameworks, strategies and outcomes in optimizing central venous access device practice in paediatrics: A scoping review.

Paediatric patients with complex or acute conditions may require a central venous access device, however, almost one-third of these devices have associated complications (e.g. infections). Implementation of evidence-based practices regarding central venous access devices can reduce and potentially prevent complications. AIMS: This scoping review aimed to explore recent interventional research in CVAD management through an implementation lens. DESIGN: This scoping review used the Arksey and O'Malley framework. Studies were included if they were written in English, published in 2012 to July 2023, involved children and were relevant to the study aims. Risk of bias was appraised by the Mixed Methods Appraisal Tool. DATA SOURCES: Searches were undertaken in EMBASE, CINAHL (Ebsco), PubMed, Web of Science and Cochrane Library (CENTRAL). RESULTS: Of the 1769 studies identified in a systematic search, 46 studies were included. Studies mostly focused on health professionals and central venous access device maintenance and had quantitative pre-post study designs. Adherence to implementation frameworks was lacking, with many studies employing quality improvement approaches. Implementation strategies were typically multipronged, using health-professional education, bundles and working groups. Bundle compliance and reductions in central line-associated bloodstream infections were the most featured outcomes, with most studies primarily focusing on effectiveness outcomes. CONCLUSION: Translation of evidence-based practices to the clinical setting is difficult and current adoption of implementation frameworks (apart from 'quality improvement') is limited. Implementation strategies are diverse and dependent on the local context, and study outcomes typically focus on the effectiveness of the physical intervention, rather than measuring the implementation effort itself. IMPLICATIONS FOR PATIENTS: Future intervention research requires a more uniform and deliberate application of implementation frameworks and strategies. IMPACT: Greater exploration of relationships between frameworks and strategies and implementation and service outcomes is required to increase understanding of their role in maximizing resources to improve health care. Adhered to best reporting guidelines as per PRISMA-ScR (Tricco et al., 2018). PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

PiccPed® app impact on nurses' knowledge to prevent adverse events for peripherally inserted central catheters (PICC) in pediatric and neonatal healthcare: A quasi-experimental study.

BACKGROUND: The PiccPed® health application was developed to support clinical decision-making in peripherally inserted central catheter (PICC) management. We aimed to evaluate its impact on nurses' knowledge regarding the prevention of PICC-associated adverse events in pediatrics and neonatology. METHODS: A quasi-experimental, pre-post intervention study, was conducted with a dependent/paired sample of pediatric and neonatal nurses from two tertiary hospitals in South Brazil. Data were collected from October 2022 to January 2023 across three phases: pre-, intervention (use of the PiccPed®) and post-test. Study outcomes were a knowledge test (15 questions) of evidence-based PICC maintenance procedures, and PiccPed® app time spent and screens used. RESULTS: A total of 56 nurses completed the study. The post-test mean score was significantly higher (12/15; standard deviation (SD) 1.9) in comparison with the pre-test (mean 9/15; SD 2.2). The change in scores was significantly higher for nurses without postgraduate qualifications, in comparison to those with (Mean Difference 1.26; p = 0.039). Each minute using the app resulted in a significant increase of 0.04 points (95% confidence interval 0.01-0.08; p = 0.014) on the mean post-test score (10.94 points). CONCLUSION: The research demonstrated that PiccPed® enhances nurses' learning regarding the prevention of adverse events associated with PICC maintenance in pediatrics and neonatology. APPLICATION TO PRACTICE: The app can be safely and effectively used for training and continuing education of nurses who care for children and neonates with PICCs.

Dressings and securement devices to prevent complications for peripheral arterial catheters.

BACKGROUND: Peripheral arterial catheters (ACs) are used in anaesthesia and intensive care settings for blood sampling and monitoring. Despite their importance, ACs often fail, requiring reinsertion. Dressings and securement devices maintain AC function and prevent complications such as infection. OBJECTIVES: To evaluate the effectiveness of peripheral AC dressing and securement devices to prevent failure and complications in hospitalised people. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus up to 16 May 2023. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to 16 May 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing different dressing and securement devices for the stabilisation of ACs in hospitalised people. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias using Cochrane's RoB 1 tool. We resolved disagreements by discussion, or by consulting a third review author when necessary. We assessed the certainty of evidence using GRADE. MAIN RESULTS: We included five RCTs with 1228 participants and 1228 ACs. All included studies had high risk of bias in one or more domains. We present the following four comparisons, with the remaining comparisons reported in the main review. Standard polyurethane (SPU) plus tissue adhesive (TA) compared with SPU: we are very uncertain whether use of SPU plus TA impacts rates of AC failure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.20 to 0.98; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Neither study (165 participants) reported catheter-related bloodstream infections (CRBSI), thus we are very uncertain whether SPU plus TA impacts on the incidence of CRBSI (very low-certainty evidence). It is very uncertain whether use of SPU plus TA impacts AC dislodgement risk (RR 0.54, 95% CI 0.03 to 9.62; I² = 44%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts AC occlusion rates (RR 1.20, 95% CI 0.37 to 3.91; I² = 3%; 2 studies, 165 participants; very low-certainty evidence). We are very uncertain whether use of SPU plus TA impacts rates of adverse events with few reported events across groups (RR 0.89, 95% CI 0.09 to 8.33; I² = 0%; 2 studies, 165 participants; very low-certainty evidence). Bordered polyurethane (BPU) compared to SPU: we are very uncertain whether use of BPU impacts rates of AC failure (RR 0.67, 95% CI 0.21 to 2.13; 1 study, 60 participants; very low-certainty evidence). BPU may make little or no difference to CRBSI compared to SPU (RR 3.05, 95% CI 0.12 to 74.45; I² = not applicable as 1 study (60 participants) reported 0 events; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to the risk of AC dislodgement compared with SPU (RR 0.75, 95% CI 0.17 to 3.22; I² = 0%; 2 studies, 572 participants; low-certainty evidence). BPU may make little or no difference to occlusion risk compared with SPU (RR 0.80, 95% CI 0.60 to 1.07; I² = 0%; 2 studies, 572 participants; low-certainty evidence). It is very uncertain whether BPU impacts on the risk of adverse events compared with SPU (RR 0.33, 95% CI 0.01 to 7.87; 1 study, 60 participants; very low-certainty evidence). SPU plus sutureless securement devices (SSD) compared to SPU: we are very uncertain whether SPU plus SSD impacts risk of AC failure compared with SPU (RR 0.78, 95% CI 0.40 to 1.52; I² = 0%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain if SPU plus SSD impacts CRBSI incidence rate with no events in both groups (2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of dislodgement (RR 0.14, 95% CI 0.01 to 2.57; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). It is very uncertain whether SPU plus SSD impacts risk of AC occlusion (RR 1.94, 95% CI 0.50 to 7.48; I² = 38%; 2 studies, 157 participants; very low-certainty evidence). We are very uncertain whether SPU plus SSD impacts on the risk of adverse events (RR 1.94, 95% CI 0.19 to 20.24; I² = not applicable as 1 study (96 participants) reported 0 events; 2 studies, 157 participants; very low-certainty evidence). Integrated securement dressings compared to SPU: integrated securement dressings may result in little or no difference in risk of AC failure compared with SPU (RR 1.96, 95% CI 0.80 to 4.84; 1 study, 105 participants; low-certainty evidence); may result in little or no difference in CRBSI incidence with no events reported (1 study, 105 participants; low-certainty evidence); may result in little or no difference in the risk of dislodgement (RR 0.33, 95% CI 0.04 to 3.04; 1 study, 105 participants; low-certainty evidence), may result in little or no difference in occlusion rates with no events reported (1 study, 105 participants; low-certainty evidence), and may result in little or no difference in the risk of adverse events (RR 0.35, 95% CI 0.01 to 8.45; 1 study, 105 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: There is currently limited rigorous RCT evidence available about the relative clinical effectiveness of AC dressing and securement products. Limitations of current evidence include small sample size, infrequent events, and heterogeneous outcome measurements. We found no clear difference in the incidence of AC failure, CRBSI, or adverse events across AC dressing or securement products including SPU, BPU, SSD, TA, and integrated securement products. The limitations of current evidence means further rigorous RCTs are needed to reduce uncertainty around the use of dressing and securement devices for ACs.

Michigan appropriateness guide for intravenous catheters in pediatrics - miniMAGIC-Brasil: translation into Brazilian portuguese.

OBJECTIVE: To perform the translation and adaptation of the Michigan Appropriateness Guide for Intravenous Catheters in Pediatrics (miniMAGIC) into Brazilian Portuguese. METHODS: Methodological study performed in five recommended stages: initial translations; synthesis of the translations; back translations; assessment of the back translations; expert committee assessment. The expert committee was composed of three registered nurses and two doctors who had a Master's and/or PhD degree, and an expertise in intravenous therapy and pediatric and neonatal care. To assess the semantic, idiomatic, experiential and conceptual adequacy, a Likert scale was applied, in which 1, "not equivalent"; 2, "inequivalent"; 3, "cannot assess"; 4, "quite equivalent"; 5, "totally equivalent". The terms mostly analyzed as negative in equivalence and with a lower than 20 score were reviewed and submitted to a new assessment, with the Delphi Technique until consensus was obtained. The results were stored in electronic spreadsheets and treated with concordance index, with a minimum acceptable result of 0.80. RESULTS: The content of all recommendations, named as miniMAGIC-Brasil, was validated by the expert committee after two stages of evaluation. All recommendations had an overall agreement index of 0.91. CONCLUSIONS: The miniMAGIC-Brazil guide was validated in respect to the adequacy of the translation after two steps.

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

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

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

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

Incidence of hospital-acquired pressure injuries and predictors of severity in a paediatric hospital.

BACKGROUND: Hospital-acquired pressure injuries (HAPIs) pose significant challenges in healthcare and cause increased patient suffering, longer hospital stays, and higher healthcare costs. Paediatric patients face unique risks, but evidence remains scarce. This study aimed to identify and describe HAPI admission incidence and severity predictors in a large Australian children's hospital. METHODS: This retrospective cohort study investigated all paediatric patients between January 2020 and December 2021 using a census approach. Demographic and clinical data including HAPI-related data were accessed from the incident monitoring and hospital administration databases. The incidence rate (per 1000 patient admissions) was calculated based on all admissions. Predictors of HAPI severity were identified using multivariable multinomial logistic regression. The study adhered to the STROBE guidelines for retrospective cohort studies. RESULTS: The HAPI incidence rate was 6.96 per 1000 patient admissions. Of the age groups, neonates had the highest HAPI incidence (15.5 per 1000 admissions). Critically ill children had the highest rate for admission location (12.8 per 1000 patient admissions). Most reported cases were stage I (64.2%). Age was associated with injury severity, with older paediatric patients more likely to develop higher-stage HAPIs. Additionally, Aboriginal and/or Torres Strait Islander patients had a higher HAPI severity risk. CONCLUSION: HAPI injuries in paediatric patients are unacceptably high. Prevention should be prioritized, and the quality of care improved in Australia and beyond. Further research is needed to develop targeted prevention strategies for these vulnerable populations. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: This research emphasizes the need for standardized reporting, culturally sensitive care and tailored prevention strategies. IMPACT: The research has the potential to influence healthcare policies and practices, ultimately enhancing the quality of patient care. REPORTING METHOD: STROBE guidelines. NO PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution to the conduct of this study.

Adverse events associated with umbilical vascular catheters in the neonatal intensive care unit: A retrospective cohort study.

BACKGROUND: Umbilical catheters are commonly inserted in newborns in the neonatal intensive care unit (NICU) yet are associated with serious adverse events (AEs) such as malposition, migration, infection, thrombosis, hepatic complications, cardiac effusion, and cardiac tamponade. There is a need to determine the incidence and risk factors for AEs to inform safe practice. OBJECTIVES: The objective of this study was to determine the incidence and risk factors for AEs (all-cause and individual types) associated with umbilical venous catheters (UVCs) and umbilical arterial catheters (UACs) in the NICU. METHODS: A retrospective cohort study was conducted in an Australian level-VI NICU over a 3-year period. Any newborn who had both a UVC and UAC insertion attempt was included. RESULTS: There were 236 neonates who had 494 catheters (245 UVCs and 249 UACs). Of these, 71% of UVCs (95% confidence interval [CI]: 65.6-76.9%; incidence rate: 181.1-237.3 per 1000 catheter days) and 43.8% of UACs (95% CI: 38-50.5%; incidence rate: 102.0-146.3 per 1000 catheter days) were associated with an AE. The most common AE was malposition on first X-ray for UVCs (60.1%, 95% CI: 55.1-67.3) and UACs (32.6%, 95% CI: 26.8-39.6). A dwell time of ≥7 days was a significant predictor of UAC failure (incidence risk ratio: 1.5, 95% CI: 1.1-2.1, p = 0.006) and migration of the UVC (incidence risk ratio: 3.5, 95% CI: 1.0-11.5, p = 0.043). CONCLUSION: Adverse events related to insertion occurred in a relatively high percentage of umbilical catheters placed. Increased dwell time remains a significant risk factor for catheter migration and overall failure. Practice change and consideration of risk factors for both individual and overall AE risk are necessary to reduce complications.

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.

Problem-solving processes for central venous catheter occlusion within pediatric cancer care: A qualitative study.

PURPOSE: Central venous access devices play a crucial role in healthcare settings. However, there is concern regarding the high incidence of blockages occurring before the completion of treatments and existing guidelines for occlusion management are not consistently followed. To explore the decision-making and problem-solving process of occlusion management and identify enablers and barriers to implementing evidence for occlusion management in pediatric cancer care. METHODS: A qualitative design with individual semi-structured interviews. Participants were selected by purposeful sampling from a tertiary-referral pediatric facility, and semi-structured interviews were conducted. RESULTS: A total of 13 clinicians and 5 parents were interviewed. The thematic analysis revealed four main decision-making/problem-solving themes: 1) clinical reasoning and judgement for central venous access devices occlusion, 2) capability in central venous access devices occlusion management, 3) colleague collaboration in the escalation process and 4) lack of adequate support to manage the occlusion. This study identified positive and negative influences on the problem-solving process, including clinicians' psychological capabilities, social and physical resources, and beliefs about consequences. CONCLUSION: This study found that clinicians in pediatric cancer care were able to manage central venous access device occlusions using clinical reasoning and judgment skills, which may conflict with evidence-based practices. The study confirmed the importance of a team approach and prior experience in managing central venous access devices in pediatric oncology settings and identified potential conflicts between clinician decisions based on the patient's current and anticipated conditions and implementation of evidence-based practice. Improving documentation and providing visual aids could benefit clinicians' problem-solving processes.

Inappropriate Use of Peripherally Inserted Central Catheters in Pediatrics: A Multisite Study.

OBJECTIVES: This study aimed to describe how the current practice of peripherally inserted central catheter (PICC) use in hospitalized children aligns with the Michigan Appropriateness Guide for Intravenous Catheters (miniMAGIC) in Children recommendations, explore variation across sites, and describe the population of children who do not receive appropriate PICCs. METHODS: A retrospective study was conducted at 4 children's hospitals in the United States. Children with PICCs placed January 2019 to December 2021 were included. Patients in the NICU were excluded. PICCs were categorized using the miniMAGIC in Children classification as inappropriate, uncertain appropriateness and appropriate. RESULTS: Of the 6051 PICCs identified, 9% (n = 550) were categorized as inappropriate, 9% (n = 550) as uncertain appropriateness, and 82% (n = 4951) as appropriate. The number of PICCs trended down over time, but up to 20% of PICCs each year were not appropriate, with significant variation between sites. Within inappropriate or uncertain appropriateness PICCs (n = 1100 PICC in 1079 children), median (interquartile range) patient age was 4 (0-11) years, 54% were male, and the main reason for PICC placement was prolonged antibiotic course (56%, n = 611). The most common admitting services requesting the inappropriate/uncertain appropriateness PICCs were critical care 24%, general pediatrics 22%, and pulmonary 20%. Complications resulting in PICC removal were identified in 6% (n = 70) of inappropriate/uncertain PICCs. The most common complications were dislodgement (3%) and occlusion (2%), with infection and thrombosis rates of 1% (n = 10 and n = 13, respectively). CONCLUSIONS: Although the majority of PICCs met appropriateness criteria, a substantial proportion of PICCs were deemed inappropriate or of uncertain appropriateness, illustrating an opportunity for quality improvement.

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.

Supportive care needs of adults living with a peripherally inserted central catheter (PICC) at home: a qualitative content analysis.

BACKGROUND: Peripherally inserted central catheters (PICCs) are common vascular access devices inserted for adults undergoing intravenous treatment in the community setting. Individuals with a PICC report challenges understanding information and adapting to the device both practically and psychologically at home. There is a lack of research investigating the supportive care needs of individuals with a PICC to inform nursing assessment and the provision of additional supports they may require to successfully adapt to life with a PICC. The aim of this study was to identify the supportive care needs of adults with cancer or infection living with a PICC at home. METHOD: Qualitative, semi-structured interviews were used to identify supportive care needs of adults living with a PICC at home. Participants were recruited from cancer and infectious diseases outpatient units. Two researchers independently analysed transcripts using content analysis. RESULTS: A total of 15 participants were interviewed (30-87 years old). There were 5 males and 10 females interviewed, 9 participants had a cancer diagnosis and most lived in a metropolitan area. Many participants lived with a partner/spouse at home and three participants had young children. Participants identified supportive care needs in the following eight categories (i (i) Adapting daily life (ii) Physical comfort (iii) Self-management (iv) Emotional impact (v) Information content (vi) Understanding information (vii) Healthcare resources and (viii) Social supports. CONCLUSIONS: Adults living with a PICC at home report a broad range of supportive care needs. In addition to practical and information needs, health consumers may also require support to accept living with a device inside their body and to assume responsibility for the PICC. These findings may provide nurses with a greater understanding of individual needs and guide the provision of appropriate supports.