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IntroductionPeripheral 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 analysisThe 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 disseminationThe 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 numberNCT05741866.

It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74–0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73–0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49–0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53–0·99; p=0·045). In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. The Medicines Company and Terumo.

Intravascular-catheter-related infections are frequent life-threatening events in health care, but incidence can be decreased by improvements in the quality of care. Optimisation of skin antisepsis is essential to prevent short-term catheter-related infections. We hypothesised that chlorhexidine–alcohol would be more effective than povidone iodine–alcohol as a skin antiseptic to prevent intravascular-catheter-related infections. In this open-label, randomised controlled trial with a two-by-two factorial design, we enrolled consecutive adults (age ≥18 years) admitted to one of 11 French intensive-care units and requiring at least one of central-venous, haemodialysis, or arterial catheters. Before catheter insertion, we randomly assigned (1:1:1:1) patients via a secure web-based random-number generator (permuted blocks of eight, stratified by centre) to have all intravascular catheters prepared with 2% chlorhexidine–70% isopropyl alcohol (chlorhexidine–alcohol) or 5% povidone iodine–69% ethanol (povidone iodine–alcohol), with or without scrubbing of the skin with detergent before antiseptic application. Physicians and nurses were not masked to group assignment but microbiologists and outcome assessors were. The primary outcome was the incidence of catheter-related infections with chlorhexidine–alcohol versus povidone iodine–alcohol in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01629550 and is closed to new participants. Between Oct 26, 2012, and Feb 12, 2014, 2546 patients were eligible to participate in the study. We randomly assigned 1181 patients (2547 catheters) to chlorhexidine–alcohol (594 patients with scrubbing, 587 without) and 1168 (2612 catheters) to povidone iodine–alcohol (580 patients with scrubbing, 588 without). Chlorhexidine–alcohol was associated with lower incidence of catheter-related infections (0·28 vs 1·77 per 1000 catheter-days with povidone iodine–alcohol; hazard ratio 0·15, 95% CI 0·05–0·41; p=0·0002). Scrubbing was not associated with a significant difference in catheter colonisation (p=0·3877). No systemic adverse events were reported, but severe skin reactions occurred more frequently in those assigned to chlorhexidine–alcohol (27 [3%] patients vs seven [1%] with povidone iodine–alcohol; p=0·0017) and led to chlorhexidine discontinuation in two patients. For skin antisepsis, chlorhexidine–alcohol provides greater protection against short-term catheter-related infections than does povidone iodine–alcohol and should be included in all bundles for prevention of intravascular catheter-related infections. University Hospital of Poitiers, CareFusion.

Summary Background The millions of peripheral intravenous catheters used each year are recommended for 72–96 h replacement in adults. This routine replacement increases health-care costs and staff workload and requires patients to undergo repeated invasive procedures. The effectiveness of the practice is not well established. Our hypothesis was that clinically indicated catheter replacement is of equal benefit to routine replacement. Methods This multicentre, randomised, non-blinded equivalence trial recruited adults (≥18 years) with an intravenous catheter of expected use longer than 4 days from three hospitals in Queensland, Australia, between May 20, 2008, and Sept 9, 2009. Computer-generated random assignment (1:1 ratio, no blocking, stratified by hospital, concealed before allocation) was to clinically indicated replacement, or third daily routine replacement. Patients, clinical staff, and research nurses could not be masked after treatment allocation because of the nature of the intervention. The primary outcome was phlebitis during catheterisation or within 48 h after removal. The equivalence margin was set at 3%. Primary analysis was by intention to treat. Secondary endpoints were catheter-related bloodstream and local infections, all bloodstream infections, catheter tip colonisation, infusion failure, catheter numbers used, therapy duration, mortality, and costs. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12608000445370. Findings All 3283 patients randomised (5907 catheters) were included in our analysis (1593 clinically indicated; 1690 routine replacement). Mean dwell time for catheters in situ on day 3 was 99 h (SD 54) when replaced as clinically indicated and 70 h (13) when routinely replaced. Phlebitis occurred in 114 of 1593 (7%) patients in the clinically indicated group and in 114 of 1690 (7%) patients in the routine replacement group, an absolute risk difference of 0·41% (95% CI −1·33 to 2·15%), which was within the prespecified 3% equivalence margin. No serious adverse events related to study interventions occurred. Interpretation Peripheral intravenous catheters can be removed as clinically indicated; this policy will avoid millions of catheter insertions, associated discomfort, and substantial costs in both equipment and staff workload. Ongoing close monitoring should continue with timely treatment cessation and prompt removal for complications. Funding Australian National Health and Medical Research Council.

Objectives This study aimed to compare the safety and effectiveness of tunneled peripherally inserted central catheters (T-PICC) vs. conventional PICCs (C-PICC) in adult cancer patients. Methods A multicentre randomized controlled trial was conducted between April 2021 and January 2022 in seven hospitals in China. 564 participants were randomly assigned to T-PICC or C-PICC. These data were collected and compared: the baseline characteristics and catheterization-related characteristics, periprocedural complications, and long-term complications. Results Five-hundred fifty-three participants (aged, 52.6 ± 12.3 years; female, 39.1%) were ultimately analyzed. No significant differences in periprocedural complications were found between the T-PICC and C-PICC groups (all p  > 0.05). Compared with C-PICC, T-PICC significantly reduced the incidence of long-term complications (26.4% vs. 39.9%, p  < 0.001). Specifically, reduced complications were found in central line-associated bloodstream infection (1.8% vs. 5.1%, p  = 0.04), thrombosis (1.1% vs. 4.0%, p  = 0.03), catheter dislodgement (4.7% vs. 10.1%, p  = 0.01), non-infectious oozing (17.3% vs. 28.6%, p  = 0.002), local infection (3.6% vs. 7.6%, p  = 0.04), skin irritation (6.1% vs. 10.9%, p  = 0.046), and reduced unplanned catheter removal (2.2% vs. 7.2%, p  = 0.005). No significant differences were found between T-PICC and C-PICC regarding catheter occlusion (6.5% vs. 5.8%, p  = 0.73) or skin damage (2.2% vs. 2.9%, p  = 0.58). Conclusion T-PICC is safe and effectively reduces long-term complications. Clinical relevance statement The tunneled technique is effective in reducing PICC-related long-term complications. Thus, it is recommended for cancer patients at high risk of PICC-related complications. Trial registration The registration number on https://www.chictr.org.cn/ is ChiCTR2100044632. The name of the trial registry is “A multicenter randomized controlled study of clinical use of tunneled vs. non-tunneled PICC”. Key Points Cather-related complications are associated with the technique of catheterization. Compared with conventional PICC, tunneled PICC reduced catheter-related long-term complications. Tunneled PICC placement provides an alternative catheterization method for cancer patients .

Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention. The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT01014273. Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38–0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76–1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43–1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28–0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13–0·71; p=0·006). Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach. Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.

Midline catheters have stood out in the last decade in Europe and North America as peripheral venous access devices with fewer complications and greater durability. However, its cost may be an obstacle to the adoption of this technology in public institutions in Brazil, which use long peripheral intravenous catheters for the same purpose. This is a randomized clinical trial protocol, registered on the ClinicalTrials.gov NCT05884294 platform, which will be conducted with two parallel, controlled, single-center, blinded groups for outcome analysis, where the groups are allocated in a 1:1 ratio, with patients over 18 years of age, admitted to clinical units of a public university hospital in Brazil who have difficult venous access defined by the Adult Difficult Intra Venous Access Scale (A-DIVA). The study intervention will be the insertion of a PowerGlide ProTM Midline 20G catheter (10 cm). The control group will receive an Introcan Safety Deep Access long peripheral intravenous catheter 20G (6.4 cm). The primary outcome will be the length of stay of vascular access free of complications (infiltration, phlebitis, occlusion, accidental withdrawal, catheter-associated bloodstream infection, and deep vein thrombosis). The economic analysis will follow micro-costing. To compare the use of the midline catheter (10 cm) in terms of the length of stay free of complications with the use of a long peripheral intravenous catheter (6.4 cm) during continuous or intermittent intravenous therapy for more than five days in adult clinical patients, with difficult venous access, hospitalized in a public institution in Brazil. It also aims to carry out an economic analysis based on micro-costing. The international literature, especially in North America and Europe, has shown that the use of midline catheters and long peripheral intravenous catheters have similarities regarding greater safety and lower risk of complications. The superiority related to the midline catheter in terms of the time of uncomplicated use in patients in need of peripherally appropriate solutions, but with high cost, is highlighted. The use of these devices remains incipient in Latin America, especially in Brazilian public institutions, requiring studies to evaluate evidence on the use and costs of these technologies in this specific population. Trial Registration: ClinicalTrials.gov. NCT05884294.

Distal radial artery (dRA) is a novel vascular access site in interventional cardiology. We evaluated the use of dRA as alternative approach to standard forearm radial artery (fRA) for invasive blood pressure monitoring in Intensive Cardiac Care Unit (ICCU). This is a single-center, randomized, noninferiority trial. Patients admitted in ICCU needing invasive blood pressure monitoring were randomly allocated to dRA or fRA access site (1:1 ratio). Primary endpoint was noninferiority of dRA in the final catheterization success rate. Secondary endpoints were: first attempt success rates; arterial catheterization time; catheterization-related quality of pain; incidence of complications. A total of 250 patients were enrolled (125 in each arm). Final success rate was 95.2% in the dRA group versus 96.8% in the fRA arm (p <0.001 for noninferiority). First attempt success rates were 59.2% with dRA and 70.4% with fRA (p = 0.12). There was no difference in arterial catheterization time and catheterization-related quality of pain between the 2 arms. Entry-site complications were reduced with dRA (6.7% vs 17.4% in the fRA group; p = 0.013); this was mainly driven by decreased incidence of hematoma (0.8% vs 6.6%; p = 0.020). A numerically lower occurrence of arterial occlusion was observed with dRA (0.8% vs 4.9%; p = 0.06). In conclusion, in ICCU patients, the use of dRA to invasively monitor blood pressure is noninferior to fRA for catheterization success rates and may reduce entry-site bleeding. •Distal radial artery (dRA) is a novel vascular access site in interventional cardiology.•We explored the potential role of an invasive arterial pressure monitoring via the dRA access in intensive cardiac care unit (ICCU) patients.•dRA showed a noninferior catheterization success compared to forearm radial artery (fRA) in ICCU patients.•Entry-site complications were lower with dRA, especially fewer hematomas.

When clinicians need to administer a vasopressor infusion, they are faced with the choice of administration via either peripheral intravenous catheter (PIVC) or central venous catheter (CVC). Vasopressor infusions have traditionally been administered via central venous catheters (CVC) rather than Peripheral Intra Venous Catheters (PIVC), primarily due to concerns of extravasation and resultant tissue injury. This practice is not guided by contemporary randomised controlled trial (RCT) evidence. Observational data suggests safety of vasopressor infusion via PIVC. To address this evidence gap, we have designed the \"Vasopressors Infused via Peripheral or Central Access\" (VIPCA) RCT. The VIPCA trial is a single-centre, feasibility, parallel-group RCT. Eligible critically ill patients requiring a vasopressor infusion will be identified by emergency department (ED) or intensive care unit (ICU) staff and randomised to receive vasopressor infusion via either PIVC or CVC. Primary outcome is feasibility, a composite of recruitment rate, proportion of eligible patients randomised, protocol fidelity, retention and missing data. Primary clinical outcome is days alive and out of hospital up to day-30. Secondary outcomes will include safety and other clinical outcomes, and process and cost measures. Specific aspects of safety related to vasopressor infusions such as extravasation, leakage, device failure, tissue injury and infection will be assessed. VIPCA is a feasibility RCT whose outcomes will inform the feasibility and design of a multicentre Phase-3 trial comparing routes of vasopressor delivery. The exploratory economic analysis will provide input data for the full health economic analysis which will accompany any future Phase-3 RCT.

Background. This prospective study compared the success rate and safety of a distal transradial artery (dTRA) approach to that of the conventional transradial artery (TRA) for coronary angiography or percutaneous coronary intervention. Methods. From January 2019 to April 2020, nine hundred consecutive patients (height < 190 cm) scheduled for coronary angiography or percutaneous coronary interventions were randomly and equally assigned to receive either dTRA or conventional TRA catheterization. Results. Successful access was achieved in 96.00% and 96.67% of the dTRA and conventional TRA groups, respectively (P=0.814). Compared with the TRA group, patients in the dTRA experienced significantly less hemostatic band removal time (150.5 ± 50.5 cf. 210.6 ± 60.5 min, P=0.032); minor bleeding of the access site (2.44% cf. 6.44%, P=0.038); hemostatic band cost (USD; 0.1 cf. 59.4, P=0); and postprocedural radial artery occlusion (1.56% cf. 3.78%, P=0.035). A lower body mass index was a higher risk factor for dTRA access failure (odds ratio = 0.79, P=0.024), with a cutoff of 22.04 kg/m2. Conclusion. Compared to conventional TRA, dTRA had a comparable high success rate, with fewer associated complications. Clinicians should use the dTRA with caution in patients with low body mass index.