Teixeira Tiago Oliveira, Hansel Leandro Augusto, Ceratti Rodrigo do Nascimento, Brum Ivana Duarte, Fernandes Arlene Gonçalves Dos Santos, Saline Carolina Geske, Junges Marina, Rabelo-Silva Eneida Rejane
Graduate Program in Nursing, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Vascular Access Program, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
PLoS One. 2025 Apr 24;20(4):e0319587. doi: 10.1371/journal.pone.0319587. eCollection 2025.
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.
在过去十年中,中线导管在欧洲和北美脱颖而出,成为并发症较少且耐用性更强的外周静脉通路装置。然而,其成本可能会阻碍巴西公共机构采用这项技术,这些机构在相同用途上使用的是外周静脉长导管。
这是一项随机临床试验方案,已在ClinicalTrials.gov NCT05884294平台注册,将采用两个平行、对照、单中心、盲法分组进行结果分析,分组比例为1:1,纳入年龄超过18岁、因成人困难静脉通路量表(A - DIVA)定义为静脉通路困难而入住巴西一所公立大学医院临床科室的患者。研究干预措施为插入一根PowerGlide ProTM 20G中线导管(10厘米)。对照组将接受一根Introcan Safety Deep Access 20G外周静脉长导管(6.4厘米)。主要结局指标将是无并发症的血管通路留置时间(包括渗漏、静脉炎、堵塞、意外拔除、导管相关血流感染和深静脉血栓形成)。经济分析将采用微观成本核算。
比较在巴西一所公立机构住院的、静脉通路困难的成年临床患者,在持续或间歇静脉治疗超过五天期间,使用10厘米中线导管和6.4厘米外周静脉长导管的无并发症留置时间。同时旨在基于微观成本核算进行经济分析。
国际文献,尤其是在北美和欧洲的文献表明,中线导管和外周静脉长导管在更高的安全性和更低的并发症风险方面具有相似性。突出了中线导管在需要外周合适解决方案但成本高昂的患者中,在无并发症使用时间方面的优势。这些装置在拉丁美洲,特别是巴西的公共机构中的使用仍处于起步阶段,需要开展研究以评估这些技术在这一特定人群中的使用证据和成本。试验注册:ClinicalTrials.gov. NCT05884294。