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

Purpose Indwelling central venous catheters (CVCs) have been increasingly used to enable delivery of intravenous chemotherapy. We aimed to compare the safety and cost of two commonly used CVCs, peripherally inserted central venous catheter (PICCs) and ports, in the delivery of chemotherapy in patients with non-haematological malignancies. Methods Seventy patients were randomly assigned to receive either a PICC or a port. The primary endpoint was occurrence of major complications, which required removal of the CVC and secondary endpoints included occurrence of any complications. Results Port devices were associated with fewer complications compared with PICC lines (hazard ratio of 0.25, CI, 0.09–0.86, P  = 0.038). Major complication rate was lower in the port arm compared to the PICC arm (0.047 versus 0.193 major complications/100 catheter days, P  = 0.034) with 6 versus 20 % of patients experiencing major complications, respectively. Thrombosis, the most common complication, was significantly higher in the PICC arm compared to the port arm (25 versus 0 %, P  = 0.013). Quality of life and cost estimates did not differ significantly between the two arms. Conclusions Port devices are associated with a lower risk of complications, with no difference in cost, compared to PICC lines in patients with non-haematological malignancies receiving intravenous chemotherapy.

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 .

ABSTRACT Objectives: to evaluate the effectiveness of peripheral central catheterization by comparing the modified Seldinger technique and the conventional technique in critically ill newborns. Methods: randomized unmasked clinical trial conducted in a public children’s hospital. Participation of 111 newborns with randomized allocation, 56 in the control group (conventional technique) and 55 in the experimental group (modified Seldinger). Success and absence of complications were evaluated as primary outcomes. The pain scale, difficulty in hemostasis, procedure time and number of punctures were considered secondary outcomes. Results: there was no statistical significance between groups, either for success (p=0.705) or absence of complications (p=0.347). A lower pain score, improved hemostasis, increased assertiveness with fewer punctures and reduced procedure time were not observed in the experimental group. Conclusions: the modified Seldinger technique did not prove to be a more effective insertion technology compared to the conventional method. Brazilian Clinical Trial Registry: RBR-69vks36. RESUMEN Objetivos: evaluar la efectividad de la cateterización central periférica entre la técnica Seldinger modificada y la técnica convencional en recién nacidos gravemente enfermos. Métodos: ensayo clínico aleatorio, abierto realizado en un hospital público de niños. Participaron 111 recién nacidos con asignación aleatoria, 56 en el grupo control (técnica convencional) y 55 en el grupo experimental (Seldinger modificada). El éxito y la ausencia de complicaciones se evaluaron como resultados primarios. La escala de dolor, la dificultad en la hemostasia, el tiempo del procedimiento y el número de punciones se consideraron resultados secundarios. Resultados: no hubo significación estadística entre los grupos, ni para el éxito (p=0,705) ni para la ausencia de complicaciones (p=0,347). No se observó menor puntuación de dolor, mejoría de la hemostasia, mayor asertividad con menos punciones y una reducción del tiempo del procedimiento en el grupo experimental. Conclusiones: la técnica Seldinger modificada no demostró ser una tecnología de inserción más eficaz en comparación con el método convencional. Registro Brasileño de Ensayos Clínicos: RBR-69vks36. RESUMO Objetivos: avaliar a efetividade do cateterismo central periférico entre a técnica de Seldinger modificada e a técnica convencional em recém-nascidos críticos. Métodos: ensaio clínico randomizado, não mascarado, realizado em um hospital público infantil. Participaram 111 neonatos com alocação randomizada, 56 no grupo controle (tecnologia convencional) e 55 no experimental (microintrodução). O sucesso e a ausência de complicações foram avaliados como desfechos primários. A escala de dor, dificuldade de hemostasia, tempo de procedimento e o número depunções foram considerados desfechos secundários. Resultados: não houve significância estatística entre os grupos, tanto para o sucesso (p=0,705), como ausência de complicações (p=0,347). No grupo experimental não foi observada menor pontuação da dor, melhora da hemostasia, aumento da assertividade com menos punções e redução do tempo de procedimento. Conclusões: a microintrodução não se mostrou como uma tecnologia insertora mais efetiva em comparação ao método tradicional. Registro Brasileiro de Ensaio Clínico: RBR-69vks36.

Background Maintaining venous access is of great clinical importance. Running a slow continuous infusion to keep the vein open (KVO) is often used in peripheral intravenous catheters (PIVCs). Previous studies have compared the effects of intermittent flushing and continuous infusion via peripherally inserted central catheters (PICCs). In this study, we applied KVO to central venous catheters (CVCs) and compared the occlusion rate of this technique with that of the intermittent flushing technique. Method This is a randomized controlled trial of 14 hospitals in China. A total of 250 patients will be recruited in this study, and they will be randomized at a 1:1 ratio. After study inclusion, patients who will undergo CVC insertion will receive intermittent flushing with prefilled saline syringes (control group) or KVO infusion with elastic pumps (test group). All the catheters will be checked for patency by scoping Catheter Injection and Aspiration (CINAS) Classification on Days 3 and 7. The primary outcome is the rate of catheter occlusion in 7 days. Patients will be followed up until 9 days after CVC insertion, catheter occlusion, or catheter removal. The secondary outcomes are the rate of catheter occlusion in 3 days, nurse satisfaction, cost-effectiveness, adverse event rate, catheter-related bloodstream infection rate, catheter-related thrombosis rate, extravasation rate, phlebitis rate, and catheter migration. Discussion We expect that the trial will generate findings that can provide an evidence-based basis for the improvement and optimization of clinical catheter flushing techniques. Trial registration Chinese Clinical Trial Registry, ChiCTR2200064007. Registered on 23 September 2022. https://www.chictr.org.cn/showproj.html?proj=177311 .

Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).

Among patients with at least moderate functional mitral regurgitation, transcatheter valve repair led to a lower rate of heart failure events during 24 months and better health status at 12 months than medical therapy alone.

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.

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.