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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.

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.

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.

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.

Bariatric surgery is an effective treatment for moderate-to-severe obesity, however, reliable vascular access during the perioperative period remains a challenge in this population. This study compared the safety and efficacy of midline catheters (MCs) and long peripheral catheters (LPCs) in patients who underwent bariatric surgery. This single-blind, randomised controlled trial was conducted at a tertiary acute hospital between September 2023 and January 2024. A totol of 224 patients were assigned to receive either MC or LPC. The primary outcome was catheter failure; secondary outcomes included insertion attempts, time to insert the device, indwelling time, complications, requirements for additional vascular access devices, and patient satisfaction. The incidence of catheter failure was significantly lower in the MCs group (10.71%) than in the LPCs group (20.54%; odds ratio [OR] 0.46; 95% confidence interval [CI], 0.22–0.99; P  = 0.043). Additionally, MCs had longer median indwelling times (7 d vs. 5 d; P  < 0.001), fewer complications (13.39% vs. 27.68%; OR 0.40; 95% CI, 0.20–0.80; P  = 0.008), and required fewer additional devices (4.46% vs. 16.07%; OR 0.24; 95% CI, 0.09–0.68; P  = 0.004). These findings suggest that MCs are a superior choice for vascular access devices in patients undergoing bariatric surgery. Trial registration : Trial registered at ClinicalTrials.gov (NCT06031545 11/09/2023).

New catheter materials for peripherally inserted central catheters (PICCs) may reduce the risk of device failure due to infectious, thrombotic, and catheter occlusion events. However, data from randomized trials comparing these catheters are lacking. We conducted a randomized, controlled, superiority trial in three Australian tertiary hospitals. Adults and children who were referred for PICC placement were assigned in a 1:1:1 ratio to receive a hydrophobic or chlorhexidine PICC or a standard polyurethane PICC and were followed for 8 weeks. The primary outcome was device failure, which was a composite of infectious (bloodstream or local) or noninfectious (thrombosis, breakage, or occlusion) complications. A total of 1098 participants underwent randomization; 365 were assigned to the hydrophobic group, 365 to the chlorhexidine group, and 368 to the standard-polyurethane group. Device failure occurred in 21 of 358 participants (5.9%) in the hydrophobic group, in 36 of 363 (9.9%) in the chlorhexidine group, and in 22 of 359 (6.1%) in the standard-polyurethane group (risk difference, hydrophobic vs. standard polyurethane, -0.2 percentage points [95% confidence interval {CI}, -3.7 to 3.2; P = 0.89]; and chlorhexidine vs. standard polyurethane, 3.8 percentage points [95% CI, -0.1 to 7.8; P = 0.06]). In the hydrophobic group as compared with the standard-polyurethane group, the odds ratio for device failure was 0.96 (95% CI, 0.51 to 1.78), and in the chlorhexidine group as compared with the standard-polyurethane group, the odds ratio was 1.71 (95% CI, 0.98 to 2.99). Complications from any cause during the period of PICC placement occurred in 77 participants (21.5%) in the hydrophobic group, in 140 (38.6%) in the chlorhexidine group, and in 78 (21.7%) in the standard-polyurethane group (odds ratio, hydrophobic vs. standard polyurethane, 0.99 [95% CI, 0.69 to 1.42]; and chlorhexidine vs. standard polyurethane, 2.35 [95% CI, 1.68 to 3.29]). No adverse events were attributable to the interventions. Among adults and children who were referred for PICC placement, the risk of device failure due to noninfectious or infectious complications was not lower with hydrophobic or chlorhexidine PICCs than with standard polyurethane PICCs. (Funded by the National Health and Medical Research Council of Australia; PICNIC Australian New Zealand Clinical Trials Registry number, ACTRN12619000022167.).

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 .

Background Peripheral intravenous catheters (PVCs) are essential invasive devices, with 2 billion PVCs sold each year. The comparative efficacy of expert versus generalist inserter models for successful PVC insertion and subsequent reliable vascular access is unknown. Methods A single-centre, parallel-group, pilot randomised controlled trial (RCT) of 138 medical/surgical patients was conducted in a large tertiary hospital in Australia to compare PVC insertion by (1) a vascular access specialist (VAS) or (2) any nursing or medical clinician (generalist model). The primary outcome was the feasibility of a larger RCT as established by predetermined criteria (eligibility, recruitment, retention, protocol adherence). Secondary outcomes were PVC failure: phlebitis, infiltration/extravasation, occlusion, accidental removal or partial dislodgement, local infection or catheter-related bloodstream infection; dwell time; insertion success, insertion attempts; patient satisfaction; and procedural cost-effectiveness. Results Feasibility outcomes were achieved: 92% of screened patients were eligible; two patients refused participation; there was no attrition or missing outcome data. PVC failure was higher with generalists (27/50, 54%) than with VASs (33/69, 48%) (228 versus 217 per 1000 PVC days; incidence rate ratio 1.05, 95% confidence interval 0.61–1.80). There were no local or PVC-related infections in either group. All PVCs ( n  = 69) were successfully inserted in the VAS group. In the generalist group, 19 (28%) patients did not have a PVC inserted. There were inadequate data available for the cost-effectiveness analysis, but the mean insertion procedure time was 2 min in the VAS group and 11 min in the generalist group. Overall satisfaction with the PVC was measured on an 11-point scale (0 = not satisfied and 10 = satisfied) and was higher in the VAS group ( n  = 43; median = 7) compared to the generalist group ( n  = 20; median = 4.5). The multivariable model identified medical diagnosis and bed-bound status as being significantly associated with higher PVC failure, and securement with additional non-sterile tape was significantly associated with lower PVC failure. Conclusion This pilot trial confirmed the feasibility and need for a large, multicentre RCT to test these PVC insertion models. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616001675415 . Registered on 6 December 2016.

Intracavitary electrocardiogram (IC ECG) guidance emerges as a new technique for peripherally inserted central catheters (PICCs) placement and demonstrates many potential advantages in recent observational studies. To determine whether IC ECG-guided PICCs provide more accurate positioning of catheter tips compared to conventional anatomical landmarks in patients with cancer undergoing chemotherapy. In this multicenter, open-label, randomized controlled study (ClinicalTrials.gov number, NCT02409589), a total of 1,007 adult patients were assigned to receive either IC ECG guidance (n = 500) or anatomical landmark guidance (n = 507) for PICC positioning. The confirmative catheter tip positioning x-ray data were centrally interpreted by independent radiologists. All reported analyses in the overall population were performed on an intention-to-treat basis. Analyses of pre-specified subgroups and a selected large subpopulation were conducted to explore consistency and accuracy. In the IC ECG-guided group, the first-attempt success rate was 89.2% (95% confidence interval [CI], 86.5% to 91.9%), which was significantly higher than 77.4% (95% CI, 73.7% to 81.0%) in the anatomical landmark group (P < 0.0001). This trend of superiority of IC ECG guidance was consistently noted in almost all prespecified patient subgroups and two selected large subpopulations, even when using optimal target rates for measurement. In contrast, the superiority nearly disappeared when PICCs were used via the left instead of right arms (interaction P-value = 0.021). No catheter-related adverse events were reported during the PICC intra-procedures in either group. Our findings indicated that the IC ECG-guided method had a more favorable positioning accuracy versus traditional anatomical landmarks for PICC placement in adult patients with cancer undergoing chemotherapy. Furthermore, there were no significant safety concerns reported for catheterization using the two techniques.

Ultrasound guided IV catheter (USGIV) access occurs frequently in Emergency Departments (EDs). This task is often performed using large, expensive, cart-based ultrasound systems (CBUS) which are frequently needed for other ED ultrasound functions and can be cumbersome to use and store. Handheld ultrasounds (HHUs) may be able to meet this need, but it is unknown if they function interchangeably with CBUS for USGIV placement. We performed a prospective, randomized, noninferiority study to compare the success rate of HHUs to CBUSs for placing USGIVs. ED patients 18 and older needing an USGIV were approached for enrollment and randomized to receive an USGIV placed by CBUS or HHU. USGIVs were placed by any ED physician or nurse trained in placement. A placement was considered attempted upon needle entry into the skin. An USGIV was successful if it was immediately flushable with saline. Data was collected on the success of IV placement, number of attempts, IV and provider characteristics, patient demographics, and length of time the USGIV lasted. Demographics and operator and IV characteristics were analyzed using Pearson's Chi square, Fischer's Exact test, or Wilcoxon rank sum tests. Non-inferiority was assessed using the Farrington-Manning test. Results were approached per protocol and analyzed in R. 312 patients were enrolled. Patient and IV characteristics were similar between groups. There was no difference in the number of successful USGIVs placed in either group (p≥0.9) with 146 in the CBUS group and 145 in the HHU group. There was no difference in the first attempt success rate between groups (p = 0.8) and HHU was noninferior to CBUS for successful USGIV placement (p = 0.0001). The rate of premature USGIV failure was similar between HHU and CBUS (4.0 % and 6.7 %). HHU was noninferior to CBUS for successful USGIV placement. There was no difference in the rate of first attempt success at placement or USGIV survival to a patient's ED disposition between groups. No significant additional training was required for ED providers of all levels to use the HHUs.