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.

• MeSH
• Central Venous Catheters adverse effects   MeSH
• Adult MeSH
• Phlebitis etiology   epidemiology   MeSH
• Catheterization, Central Venous adverse effects   instrumentation   methods   MeSH
• Catheter-Related Infections * epidemiology   prevention & control   MeSH
• Middle Aged MeSH
• Humans MeSH
• Catheterization, Peripheral adverse effects   instrumentation   MeSH
• Prospective Studies MeSH
• Aged MeSH
• Catheters, Indwelling adverse effects   MeSH
• Venous Thrombosis epidemiology   etiology   prevention & control   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Observational Study MeSH
• Geographicals
• Europe MeSH

• MeSH
• Humans MeSH
• Risk Factors MeSH
• Thrombophlebitis * MeSH
• Veins anatomy & histology   diagnostic imaging   physiopathology   MeSH
• Venous Insufficiency * diagnosis   therapy   MeSH
• Venous Thrombosis * diagnosis   therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

• MeSH
• Anticoagulants administration & dosage   MeSH
• Humans MeSH
• Thrombophlebitis * diagnostic imaging   drug therapy   therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

Cíl: Cílem studie bylo zjistit incidenci infuzní flebitidy u dětí hospitalizovaných s onemocněním diabetes mellitus se zavedeným periferním žilním katétrem. Metodika: Observační studie zkoumala místo zavedení periferního žilního katétru (PŽK) pomocí hodnotícího nástroje Visual Infusion Phlebitis scale - VIP scale (Tab. 1) u 209 dětí ve věku 6-11 let. Výzkum probíhal v 7 nemocnicích Moravskoslezského kraje. Hodnocení místa zavedení PŽK probíhalo ve 12hodinových intervalech po celou dobu zavedení PŽK, hodnocení prováděly sestry na daných odděleních. Výsledky: Nejčastěji, konkrétně u 48 dětí (22,97%), byl u všech zavedených PŽK sledován výskyt infuzní flebitidy prvního stupně. Druhý stupeň byl zjištěn u 16 (7,66%) zavedených PŽK. U dětí hospitalizovaných s onemocněním diabetes mellitus (n = 40; 19,14%) byl pozorován zvýšený výskyt prvního stupně infuzní flebitidy ve 20 případech (50%) a druhého stupně v 9 případech (22,5%). V porovnání s dětmi, které byly hospitalizovány pro jiná onemocnění, zde tedy byla shledána statistická významnost p = 0,000. Třetí až pátý stupeň infuzní flebitidy nemělo ve sledovaném vzorku žádné dítě. Nejvyšší (n = 23; 33,3%) výskyt infuzní flebitidy prvního stupně byl zaznamenán 3. den po zavedení PŽK, přičemž byla zjištěna statistická významnost p = 0,0260. Z výzkumu dále vyplynulo, že věk, pohlaví a velikost PŽK neměly vliv na výskyt této komplikace v místě zavedení PŽK u hospitalizovaných dětí. Závěr: Tato studie měřila incidenci infuzní flebitidy pomocí VIP scale. Incidence infuzní flebitidy prvního stupně byla sledována v necelých 23%, druhého stupně v necelých 8% u všech zavedených PŽK hospitalizovaných dětí. Bylo zjištěno, že faktory, jako je onemocnění diabetes mellitus a počet dnů zavedení PŽK, jsou statisticky významnými prediktory přítomnosti této komplikace. Prevence vzniku infuzní flebitidy může nejen snížit náklady a pracovní zátěž sester, ale především stres a bolest u hospitalizovaných dětí.

Objective: The objective of the study was to determine the incidence of infusion phlebitis in children hospitalized with diabetes mellitus with an inserted peripheral venous catheter. Methodology: An observational study examined the insertion site of a peripheral venous catheter (PVC) using the Visual Infusion Phlebitis scale - VIP scale (Appendix 1) in 209 children aged 6-11 years. The research took place in 7 hospitals in the Moravian-Silesian Region. The evaluation of the PVC insertion site took place at 12-hour intervals during the entire indwelling time. The evaluation was performed by nurses in the wards. Results: The incidence of first-degree infusion phlebitis was observed most frequently, specifically in 48 children (22.97%), in all inserted PVCs. The second degree of infusion phlebitis was found in 16 (7.66%) inserted PVCs. In children hospitalized with diabetes mellitus (n = 40; 19.14%), an increased incidence of first-degree infusion phlebitis was observed in 20 cases (50%) and second-degree in 9 cases (22.5%). In comparison with children who were hospitalized for other diseases, a statistical significance of p = 0.000 was found here. No child had third to fifth degree infusion phlebitis in the study sample. The highest incidence of first-degree infusion phlebitis (n = 23; 33,3%) was recorded on day 3 after the PVC insertion, with a statistical significance of p = 0.0260. The research also showed that age, sex and size of PVC did not affect the incidence of this complication at the PVC insertion site in hospitalized children. Conclusion: This study measured the incidence of infusion phlebitis using a VIP scale. The incidence of first-degree infusion phlebitis was monitored in less than 23% and second-degree infusion phlebitis in less than 8% of all inserted PVCs in hospitalized children. Factors such as diabetes mellitus and the number of days of PVC were found to be statistically significant predictors of this complication. Prevention of infusion phlebitis can not only reduce the costs and workload of nurses, but above all reduce stress and pain in hospitalized children.

• MeSH
• Child MeSH
• Phlebitis * etiology   pathology   MeSH
• Incidence MeSH
• Administration, Intravenous nursing   adverse effects   MeSH
• Humans MeSH
• Catheterization, Peripheral nursing   adverse effects   MeSH
• Observational Studies as Topic MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Male MeSH
• Female MeSH

• MeSH
• Cardiovascular Agents administration & dosage   classification   MeSH
• Classification MeSH
• Humans MeSH
• Practice Guidelines as Topic MeSH
• Thrombophlebitis etiology   drug therapy   prevention & control   MeSH
• Vascular Surgical Procedures methods   MeSH
• Venous Insufficiency * surgery   drug therapy   complications   pathology   therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Newspaper Article MeSH
• Review MeSH

• MeSH
• Endovascular Procedures methods   MeSH
• Cardiovascular Agents therapeutic use   MeSH
• Humans MeSH
• Thrombophlebitis drug therapy   MeSH
• Varicose Veins surgery   therapy   MeSH
• Veins anatomy & histology   surgery   pathology   MeSH
• Venous Insufficiency * etiology   drug therapy   classification   complications   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

• MeSH
• Humans MeSH
• Thrombophlebitis * diagnosis   complications   therapy   MeSH
• Varicose Veins diagnostic imaging   complications   therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

• MeSH
• Travel MeSH
• Travel-Related Illness * MeSH
• Communicable Diseases, Imported prevention & control   MeSH
• Humans MeSH
• Immunization Schedule MeSH
• Pre-Exposure Prophylaxis MeSH
• Primary Prevention methods   standards   MeSH
• Thrombophlebitis etiology   prevention & control   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

• MeSH
• Phlebitis nursing   MeSH
• Cachexia nursing   MeSH
• Pain Management MeSH
• Pancreatic Neoplasms diagnosis   etiology   complications   nursing   psychology   therapy   MeSH
• Risk Factors MeSH
• Anxiety MeSH
• Publication type
• Case Reports MeSH

• MeSH
• Embolism and Thrombosis MeSH
• Humans MeSH
• Neoplasms complications   MeSH
• Prognosis MeSH
• Risk Factors MeSH
• Thrombophlebitis diagnosis   therapy   MeSH
• Venous Thromboembolism MeSH
• Venous Thrombosis * diagnosis   epidemiology   physiopathology   therapy   MeSH
• Check Tag
• Humans MeSH