Performance and safety of PowerPICC catheters and accessories: a prospective observational study.

OBJECTIVE: This study aimed to evaluate the safety and performance of PowerPICC catheters in a real-world setting. DESIGN: Prospective, observational, multicentre study. SETTING: Nine European countries, involving 14 centres. PARTICIPANTS: General patient population. INTERVENTION: PowerPICC catheter inserted by the clinician as standard of care with routinely collected outcomes followed through device removal or 180 days postinsertion. PRIMARY AND SECONDARY OUTCOMES MEASURES: Safety and performance outcomes were assessed for PowerPICC, PowerPICC SOLO 2 and PowerGroshong PICC. The primary safety endpoint was the incidence of symptomatic venous thrombosis (VT), and secondary safety endpoints included phlebitis, extravasation, vessel laceration, vessel perforation local infection, accidental dislodgment and catheter-related bloodstream infection (CRBSI). The primary performance endpoint was the percentage of patients whose PowerPICC device remained in place through the completion of therapy. The secondary performance endpoints included catheter patency, placement success in a single attempt and usability. RESULTS: The enrolled patients (N=451) received either PowerPICC, PowerPICC SOLO 2 or PowerGroshong PICC catheters. Across all devices, 1.6% of patients developed symptomatic VT, and CRBSI occurred in 1.6% of patients. There were no cases of phlebitis or extravasation and only three cases of vein laceration or vein perforation. The catheters showed high success rates in completing therapy (81.8%), maintaining patency (93.9%) and achieving successful placement in a single attempt (90.4%). Clinicians overwhelmingly agreed that both the guidewire and stylet (93.3% and 94.4%, respectively) were easy or very easy to use. CONCLUSIONS: This study demonstrates the safety and performance of PowerPICC catheters across diverse settings and patient cohorts in real-world hospital settings across Europe. The findings indicate that these catheters are safe and can be effectively used in the general patient setting and when inserted by a variety of clinicians. The low incidence of complications and high success rates further support the clinical utility of these catheters. TRIAL REGISTRATION NUMBER: NCT04263649.

Exploration of the Current State of Peripheral Intravenous Catheter Complications and Documentation: A Point Prevalence Study.

Peripheral intravenous catheters (PIVCs) are the most commonly used invasive devices in acute care hospitals, with nurses being primarily responsible for the insertion and care of these devices. This point prevalence study aimed to describe current PIVC status and nursing documentation in a large, regional health care system and to explore variables associated with PIVC complications. The study was conducted with adult inpatients. There were 665 PIVCs included in the study. Dressings were clean, dry, and intact in 83% of observations; only 2.7% did not have a transparent dressing. Thirty-one percent of PIVCs were inserted in areas of flexion. Median dwell time was 2.39 days (± 2.36 days), with upper arm sites having the longest dwell time. Overall inter-rater reliability (IRR) for an infiltration or phlebitis score of 0 was high (97.4% and 92%, respectively). However, overall agreement was only 77.16% for infiltration and 40.07% for phlebitis, with significant disagreement as scores increased. Study findings support that there was strong compliance with the Infusion Nurses Society's (INS) Infusion Therapy Standards of Practice vascular access practice recommendations; however, opportunities to improve infiltration/phlebitis assessment and documentation exist.

Management from a multidisciplinary perspective of phlebitis related to peripheral venous catheter insertion: An international Delphi study.

AIM: To determine the consensus and importance of care practices related to the management of peripheral venous catheter (PVC)-related phlebitis in hospitalized patients through the views of experts from different disciplines. BACKGROUND: PVCs are commonly used in hospitals but are associated with complications such as phlebitis. Their management differs widely, and studies are heterogeneous. DESIGN: Delphi method. METHODS: Four stages: problem area (with Web of Science bibliometric review in July 2022), panel members, two Delphi rounds and closing criteria. In the Delphi survey, experts answered an online questionnaire based on assessment, treatment and follow-up dimensions (September 2022-February 2023). Statistical analyses were conducted of frequencies, percentages, measures of central tendency and levels of dispersion (QD). A space for comments was created, and a thematic analysis conducted of them. RESULTS: Eighteen experts (nurses, doctors and pharmacists) participated in the Delphi rounds. Forty-five activities were identified: 19 in assessment, 15 in treatment and 11 in follow-up. A high consensus level (QD ≤ 0.6) was found in five activities (11.12%), moderate level (0.6 < QD < 1.0) in 19 (42.22%) and low level (QD > 1.0) in 21 (46.66%). Seven themes were determined (patient perspective, lack of consensus, low evidence-based practices, stage-based treatments, prevention activities, high variability in practice and specialist teams and interdisciplinary work). CONCLUSION: The importance of systematic assessment scales is highlighted together with consensus on signs and symptoms (pain, redness, inflammation, palpable cord and induration). Treatment according to severity and daily visual recording and monitoring are emphasized along with the need for patient participation and healthcare literacy. A high level of consensus was obtained in 11% of the activities, showing the large variability of criteria and interventions for phlebitis management. Highlighted needs include working in a team, the use of specialist teams and promoting evidence- and prevention-based activities. RELEVANCE TO CLINICAL PRACTICE: Clinical variability is noted and, therefore, the importance of consensus on standardized care for PVC phlebitis and evidence-based practice. REPORTING METHOD: Delphi studies (CREDES). PATIENT OR PUBLIC CONTRIBUTION: Experts contribution.

Peripheral intravenous catheter-induced phlebitis in a tertiary hospital of Karachi: a cohort study.

PURPOSE: This study aimed to determine the incidence of peripheral intravenous catheter (PIVC)-induced phlebitis and its predictors among adult patients hospitalized at Dow University Hospital, Karachi, Pakistan. METHODS: A sample of 258 adult patients admitted in the selected wards and planned for peripheral intravenous catheter insertion were recruited through consecutive sampling during March to May 2019. Daily follow-ups were performed to observe signs of phlebitis using a validated tool. The cohort was followed until discharge, removal of peripheral intravenous catheter, or study conclusion. RESULTS: Of 258 patients studied, 139 (53.9%) were females. A significant number of the participants 104 (40.3%) were young adults of age 20-40 years. The incidence of phlebitis was 39.1%. Tuberculosis (TB), peripheral intravenous catheter dwell time before initial assessment, administration of IV fluids, and dissatisfactory nursing care at Day 1 were associated significantly with the development of phlebitis. There was a doseresponse relationship between the catheter dwell time in hours before initial assessment and the development of phlebitis. CONCLUSION: This study found an increased incidence (39.1%) in three months of PIVC-induced phlebitis among adult patients. In addition to patient-related and PIVC-related risk factors considered in this study, PIVC-induced phlebitis is found to be significantly associated with the level of PIVC care provided by nurses. Continuous nursing education, developing standard care plans for PIVCs, and proper documentation of care are recommended.

Deep Learning for Predicting Phlebitis in Patients with Intravenous Catheters.

This study presents a deep learning model to predict phlebitis in patients with peripheral intravenous catheter (PIVC) insertions. Leveraging electronic health record data from 27,532 admissions and 70,293 PIVC events at a hospital in Seoul, South Korea, the study involved analyzing patient demographics, PIVC-specific features, and drug-related information. The developed deep learning model was benchmarked against various machine learning models, demonstrating superior performance with an accuracy of 0.93 and an AUC of 0.89. This highlights its potential as an effective tool for early detection of phlebitis, promising enhanced patient outcomes and healthcare efficiency.

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.

Peripheral Intravenous Catheter-Related Phlebitis and Infiltration in an Emergency Department: A Descriptive Study.

This study aims to analyze the incidences of peripheral intravenous catheter-related phlebitis and infiltration and the associated risk factors in emergency departments. This descriptive cross-sectional, nonexperimental study was conducted with 300 participants in the emergency department of a university hospital in Türkiye between January 15 and February 15, 2018. The incidence of peripheral intravenous catheter-related phlebitis was 31%, which was grade 1 in 29.7% and grade 2 in 1.3% of the emergency department participants. Additionally, the incidence of peripheral intravenous catheter-related infiltration was 55.4%, including grades 1, 2, and 3 in 36.0%, 12.7%, and 6.7% of the participants, respectively. Incidences of phlebitis and infiltration were related to age, duration of peripheral intravenous catheterization longer than 24 hours, and repeated use of the catheter insertion site. The findings of this study may draw attention to the factors that trigger phlebitis and infiltration due to peripheral intravenous catheter insertions in the emergency department and may guide practices to prevent these complications before they develop. In this context, the Phlebitis Scale and Infiltration Scale developed by the Infusion Nurses Society are recommended to be used in the emergency department.

Obesity-Related Traits Mediate the Effects of Educational Attainment on the Risk of Varicose Veins, Venous Thromboembolism, and Phlebitis.

BACKGROUND: The extent to which educational attainment (EA) influences the risk of varicose veins (VVs), venous thromboembolism (VTE), and phlebitis occurrence, whether this pathway is mediated by obesity-related traits, and the proportion of their mediation is unknown. METHODS: A Mendelian randomization (MR) design was used to genetically investigate the causal effects of EA on the risk of VV, VTE, and phlebitis and to assess the mediating effect of obesity-related traits. Causal effects were estimated using primarily the multiplicative random-effects inverse variance-weighted method. This was supplemented by Cochran's Q-statistic, MR-Egger regression, MR funnel plots, and leave-one-out test to evaluate the reliability of the results. For the individual mediation effect, the coefficient product method was mainly utilized to estimate. RESULTS: An increase in genetically predicted EA was associated with a lower risk of VV, VTE, and phlebitis, as well as lower body mass index, basal metabolic rate, hip circumference, and waist circumference. As genetically predicted body mass index, basal metabolic rate, hip circumference, and waist circumference increased, the risk of developing VV, VTE, and phlebitis increased, respectively. Body mass index, basal metabolic rate, hip circumference, and waist circumference were identified as mediators of the protective effects of EA on VV, VTE, and phlebitis. CONCLUSION: The findings support a causal relationship between higher EA and lower risk of VV, VTE, and phlebitis. Obesity-related traits play a significant mediating role in these pathways, and there are interactions between them, with hip circumference mediating these pathways relatively independently from the other three.

Effectiveness and Safety of Measures to Prevent Infections and Other Complications Associated With Peripheral Intravenous Catheters: A Systematic Review and Meta-analysis.

BACKGROUND: Peripheral intravenous catheters (PIVCs) contribute substantially to the global burden of infections. This systematic review assessed 24 infection prevention and control (IPC) interventions to prevent PIVC-associated infections and other complications. METHODS: We searched Ovid MEDLINE, Embase, Cochrane Library, WHO Global Index Medicus, CINAHL, and reference lists for controlled studies from 1 January 1980-16 March 2023. We dually selected studies, assessed risk of bias, extracted data, and rated the certainty of evidence (COE). For outcomes with 3 or more trials, we conducted Bayesian random-effects meta-analyses. RESULTS: 105 studies met our prespecified eligibility criteria, addressing 16 of the 24 research questions; no studies were identified for 8 research questions. Based on findings of low to high COE, wearing gloves reduced the risk of overall adverse events related to insertion compared with no gloves (1 non-randomized controlled trial [non-RCT]; adjusted risk ratio [RR], .52; 95% CI, .33-.85), and catheter removal based on defined schedules potentially resulted in a lower phlebitis/thrombophlebitis incidence (10 RCTs; RR, 0.74, 95% credible interval, .49-1.01) compared with clinically indicated removal in adults. In neonates, chlorhexidine reduced the phlebitis score compared with non-chlorhexidine-containing disinfection (1 RCT; 0.14 vs 0.68; P = .003). No statistically significant differences were found for other measures. CONCLUSIONS: Despite their frequent use and concern about PIVC-associated complications, this review underscores the urgent need for more high-quality studies on effective IPC methods regarding safe PIVC management. In the absence of valid evidence, adherence to standard precaution measures and documentation remain the most important principles to curb PIVC complications. CLINICAL TRIALS REGISTRATION: The protocol was registered in the Open Science Framework (https://osf.io/exdb4).

Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database.

BACKGROUND: It remains unclear whether peripherally inserted central catheters (PICCs) are superior to central venous catheters (CVCs); therefore, we compared post-implantation complications between CVC and PICC groups. RESEARCH DESIGN AND METHODS: Patients who received CVCs or PICCs between April 2010 and March 2018 were identified from the Diagnosis Procedure Combination database, a national inpatient database in Japan. The outcomes of interest included catheter infection, pulmonary embolism, deep vein thrombosis, and phlebitis. Propensity score overlap weighting was used to balance patient backgrounds. Outcomes were compared using logistic regression analyses. RESULTS: We identified 164,185 eligible patients, including 161,605 (98.4%) and 2,580 (1.6%) in the CVC and PICC groups, respectively. The PICC group was more likely to have overall complications (odds ratio [OR], 1.70; 95% confidence interval [CI], 1.32-2.19), pulmonary embolism (OR, 2.32; 95% CI, 1.38-3.89), deep vein thrombosis (OR, 1.86; 95% CI, 1.16-2.99), and phlebitis (OR, 1.72; 95% CI, 1.27-2.32) than the CVC group. There was no significant intergroup difference in catheter infection (OR, 1.09; 95% CI, 0.39-3.04). CONCLUSIONS: Patients with PICCs had a significantly greater incidence of complications than did those with CVCs. Further research is necessary to explore the factors contributing to these complications.

Mannitol versus furosemide in patients with thoracic malignancies who received cisplatin-based chemotherapy using short hydration: A randomized phase II trial.

BACKGROUND: Mannitol is exclusively recommended in the National Comprehensive Cancer Network guidelines for diuresis in cisplatin (CDDP)-based chemotherapy. The utility of furosemide, a widely used and convenient diuretic, thus requires clarification. METHODS: This is a prospective, single-centered, open-label, noninferiority phase II study. Patients with thoracic malignancies who planned to receive CDDP-based chemotherapy were randomly assigned to receive either mannitol (arm A) or furosemide (arm B). The primary end point was set as the proportion of patients who experienced any grade of "creatinine (Cr) increased" based on the upper limit of the normal range (ULN) during the first cycle as assessed by Common Terminology Criteria for Adverse Events Version 4.0. Secondary end points were Cr increased based on the baseline value during the first cycle, Cr increased after the completion of CDDP, and the proportion of patients with phlebitis. RESULTS: Between April 2018 and March 2022, 115 patients were enrolled and 106 were analyzed. Any grade of Cr increased based on the ULN during the first cycle was 17.3% (arm A) and 24.1% (arm B), respectively (p = 0.34). Therefore, the primary end point was not met. After completion of chemotherapy, any grade of Cr increased was observed in 23.1% (arm A) and 31.5% (arm B), respectively. However, the actual serum Cr level and Cr clearance during the courses were not different between the arms. Phlebitis occurred more frequently in arm A (28.8%) than arm B (16.7%). CONCLUSIONS: Mannitol should remain the standard diuresis in CDDP-based chemotherapy assessed by conventional CTCAE grading, but furosemide can be room for consideration when assessed by actual serum Cr level and Cr clearance.

Impact of an interventional bundle on complications associated with peripheral venous catheters in elderly patients.

PURPOSE: Elderly patients admitted to geriatrics departments often require peripheral venous catheters (PVC), which should be inserted and maintained following a series of preventive recommendations. Our objective was to evaluate the impact of a training bundle comprising measures aimed at reducing complications associated with the use of PVC in elderly patients admitted to a tertiary teaching hospital. METHODS: We performed a prospective study of patients who received a PVC within 24 h of admission to a geriatrics department. After a 10-month pre-interventional period, we implemented an educational and interventional bundle over a 9-month period. Follow-up was until catheter withdrawal. We analyzed and compared clinical and microbiological data between both study periods. RESULTS: A total of 344 patients (475 PVC) were included (pre-intervention period, 204 patients (285 PVC); post-intervention period, 140 patients (190 PVC)). No statistically significant differences in demographic characteristics were observed between the study periods. The colonization and phlebitis rates per 1000 admissions in both periods were, respectively, 36.7 vs. 24.3 (p = 0.198) and 81.5 vs. 65.1 (p = 0.457). The main reason for catheter withdrawal was obstruction/malfunctioning (33.3%). Obstruction rate was higher for those inserted in the hand than for those inserted at other sites (55.7% vs. 44.3%, p = 0.045). CONCLUSIONS: We found no statistically significant differences regarding phlebitis and catheter tip colonization rates. It is necessary to carry out randomized studies assessing the most cost-effective measure to reduce complications associated with PVC.

Phlebitis in Medical-Surgical Units: A Case-Control Study in a Brazilian Hospital.

The most commonly used vascular access is the peripheral intravenous catheter (PIVC). However, it can trigger complications and the occurrence of adverse events, such as phlebitis. This study evaluated the variables that are associated with the occurrence of phlebitis in medical and surgical inpatient units. This is an observational, retrospective, case-control study in medical and surgical hospitalization units of a private general hospital in the city of São Paulo. Participants were an average age of 66.3 years, and 71% were hospitalized in medical units. The risk variables associated with phlebitis were medical hospitalization (odds ratio [OR] = 4.36; P = .002), presence of comorbidity (OR = 10.73; P < .001), and having 5 or more PIVCs (OR = 53.79; P = .001). Regarding intravenous therapy, the use of contrast was a risk variable (OR = 2.23; P = .072). On the other hand, patient education regarding PIVCs was a protective measure against the development of phlebitis. The nursing team plays an essential role in the care of patients with PIVCs, inpatient guidance, planning, and device choice, taking into account the risk factors for phlebitis to maintain the preservation of vascular health and reduce adverse events.

Comparison of the physicochemical properties of branded and generic glucose-added maintenance hypotonic infusion fluids to assess the potential for phlebitis and incompatibility with other drugs.

In Japan, the switch from branded to generic infusion fluids has been promoted as a national policy. Recently, as generic products have been in short supply, the switch from generic to branded infusion fluids has increased. However, certain additives for injectable infusion fluids, such as nonvolatile acids like acetic acid and hydrochloric acid, are not required to be listed in the package insert. We hypothesized that the addition of nonvolatile acids may be one of the reasons for the differences in physicochemical properties between the branded and generic infusion fluids. We have previously reported that in other types of electrolyte infusion fluids, a variation in pH can cause incompatibility with other drugs, and variation in titratable acidity and osmolality can lead to phlebitis. Glucose-added maintenance hypotonic infusion fluid (listed as type-3G) is commonly used as a maintenance solution when energy support is needed. However, nonvolatile acid is added to prevent the caramelization of glucose, resulting in higher osmolality and titratable acidity and lower pH. Therefore, we hypothesized that both phlebitis and incompatibility with other drugs are likely to occur; hence, we measured and evaluated the physicochemical properties of branded and generic type-3G infusion fluids. We show that the osmolality, pH, and titratable acidity of all evaluated branded and generic products differed significantly and that these properties should be evaluated together to avoid phlebitis and incompatibility with other drugs when switching between branded and generic type-3G infusion fluids.

Evaluation of the effect of proximal massage and palm fisting in reducing the risk of peripheral venous catheter-related phlebitis: randomized control study.

AIMS: Peripheral venous catheter (PVC) is a clinical procedure often performed by nurses in hospitals. Phlebitis can be prevented with more nursing care by applying PVC by trained nurses and using preventive methods. The aim of this study was to investigate the effect of proximal massage and palm fisting on the prevention of phlebitis in patients with a PVC. METHODS AND RESULTS: This randomized controlled study was conducted with patients who were hospitalized in the orthopaedics and traumatology service of a state hospital and had PVC. While the study group (n = 36) received proximal massage and palm fisting on the side with a PVC, the control group (n = 36) received standard care for PVC. The data were collected by using the 'Patient Demographics and Clinical Information Form', 'Peripheral Venous Catheter-Related Phlebitis Risk Scale', and 'Visual Infusion Phlebitis Assessment Scale'. There were no statistically significant differences between the groups regarding phlebitis development based on age, sex, chronic disease status, PVC insertion site, devices in the PVC, or fluids administered from the PVC. However, there was a significantly higher risk of PVC-induced phlebitis in patients who received proximal massage and palm fisting at 48 and 96 h, when the severity of phlebitis was evaluated on daily basis. CONCLUSION: The study showed promising results, suggesting that proximal massage and palm fisting may be a simple and inexpensive technique to prevent the occurrence of phlebitis in PVC patients. REGISTRATION: ClinicalTrials.gov: NCT05714137.

Effects of the low-speed continuous infusion catheter technique on double-lumen central venous catheters: A randomized controlled trial.

BACKGROUND: Central venous catheters are widely used in clinical practice, and the incidence of central venous catheter occlusion is between 25 % and 38 %. The turbulence caused by the pulsatile flushing technique is harmful to the vascular endothelium and may lead to phlebitis. The low-speed continuous infusion catheter technique is a new type of continuous infusion that ensures that the catheter is always in a keep-vein-open state by continuous low-speed flushing; hence, avoiding the problem of catheter occlusion. OBJECTIVE: To investigate the effectiveness of the low-speed continuous infusion catheter technique and the routine care of double-lumen central venous catheters. DESIGN: This was a prospective, randomized, controlled, open-label trial. SETTING: Patients were recruited from 14 medical institutions in China between February and June 2023. PARTICIPANTS: In total, 251 patients were recruited, with 125 in the intervention group and 126 in the control group. METHODS: Patients who used double-lumen central venous catheters for infusion treatment were selected, and those who met the sampling criteria were randomly divided into intervention and control groups using the random envelope method. The intervention group used the low-speed continuous infusion catheter technique to maintain catheter patency, whereas the control group used routine care with a trial period of 7 days. The primary outcome was the occlusion rate. The secondary outcomes included nursing satisfaction and complication rates of the two groups. RESULTS: After 7 days, the rate of catheter occlusion was 28.0 % (35/125, 95 % confidence interval (CI):0.203, 0.367) in the intervention group and 53.97 % (68/126, 95 % CI: 0.449-0.629) in the control group, with a statistically significant difference (χ2 = 17.488, p < 0.001); at 3 days of intervention, the rate of catheter blockage was 8.0 % (10/125, 95 % CI: 0.039-0.142) in the intervention group and 23.8 % (30/126, 0.167-0.322) in the control group, with a statistically significant difference (χ2 = 11.707, p < 0.001). Nurse satisfaction was significantly higher in the intervention group (115/125, 92.0 %, 95 % CI: 0.858-0.961) than in the control group (104/126, 82.54 %, 95 % CI: 0.748-0.887) (χ2 = 5.049, p = 0.025). There were no statistically significant complication rates in either group (p = 0.622). CONCLUSION: The low-speed continuous infusion catheter technique helps maintain catheter patency, improves nurse satisfaction, and provides a high level of safety. REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2200064007, www.chictr.org.cn). The first recruitment was conducted in February. https://www.chictr.org.cn/showproj.html?proj=177311.