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用于静脉治疗的中线静脉导管与外周静脉穿刺中心静脉导管的比较:一项随机临床试验

Midline Venous Catheter vs Peripherally Inserted Central Catheter for Intravenous Therapy: A Randomized Clinical Trial.

作者信息

Bentridi Ahmed, Giroux Marie-France, Soulez Gilles, Bouchard Louis, Perreault Pierre, Chouinard Audrey, Dorais Marc, Do Amaral Ricardo, Bernier Pascaline, Therasse Eric

机构信息

Department of Vascular and Interventional Radiology, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada.

Now with Department of Radiology, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.

出版信息

JAMA Netw Open. 2025 Mar 3;8(3):e251258. doi: 10.1001/jamanetworkopen.2025.1258.

Abstract

IMPORTANCE

Peripherally inserted central catheters (PICCs) are frequently used for peripheral intravenous therapy (IVT) that could be administered through a peripheral midline venous catheter (MVC).

OBJECTIVE

To assess the noninferiority of MVCs compared with PICCs as a reliable vascular access for peripheral IVT and blood draws for IVT that does not require a central VC.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted in a single tertiary care center from September 2018 to March 2022. Participants were all consecutive adult patients who were referred for PICC and eligible for MVC. Patients likely to require a central VC (those in the critical care unit, those with kidney failure, or those requiring a multilumen VC) were excluded. Analyses were based on the evaluable population.

INTERVENTIONS

Participants were randomized 1:1 to either MVC or PICC. For the MVC group, a 20-cm-long, 4F (French), single-lumen MVC without a valve was used without fluoroscopic assistance. For the PICC group, a 4F, single-lumen PICC without a valve was positioned under fluoroscopy at the cavoatrial junction.

MAIN OUTCOMES AND MEASURES

The primary outcome was the percentage of patients without VC-related adverse events or dysfunctions requiring medical intervention during follow-up. A noninferiority test was performed to compare the proportion of adverse events or dysfunctions between the MVC and PICC groups. A noninferiority margin was set at 10% and a 5% 1-sided significance level.

RESULTS

Of the 6821 patients referred to the tertiary care center for PICC insertion, 294 (180 males [61.2%]; median [IQR] age, 56.3 [38.2-66.7] years) were randomized to receive MVCs (n = 146) or PICCs (n = 148); 135 and 137 participants, respectively, were included in data analysis after exclusion of those who did not complete follow-up. Ninety of 135 patients (66.7%) in the MVC group and 128 of 137 (93.4%) in the PICC group were without VC-related adverse event or dysfunction. The noninferiority of MVC could not be demonstrated (P > .99 for noninferiority).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, MVCs were associated with a significantly higher percentage of patients with VC-related adverse events or dysfunctions and could not be demonstrated as a noninferior alternative to PICCs.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03502980.

摘要

重要性

经外周静脉穿刺中心静脉导管(PICC)常用于外周静脉治疗(IVT),而此类治疗也可通过外周中线静脉导管(MVC)进行。

目的

评估MVC与PICC相比作为外周IVT可靠血管通路以及用于无需中心静脉导管(VC)的IVT抽血的非劣效性。

设计、地点和参与者:这项随机临床试验于2018年9月至2022年3月在一家三级医疗中心进行。参与者为所有连续的成年患者,这些患者被转诊接受PICC且符合MVC使用条件。可能需要中心VC的患者(重症监护病房患者、肾衰竭患者或需要多腔VC的患者)被排除。分析基于可评估人群。

干预措施

参与者按1:1随机分为MVC组或PICC组。对于MVC组,使用一根20厘米长、4F(法式)、无瓣膜的单腔MVC,无需荧光透视辅助。对于PICC组,一根4F、无瓣膜的单腔PICC在荧光透视引导下置于腔房交界处。

主要结局和测量指标

主要结局是随访期间无需要医疗干预的VC相关不良事件或功能障碍的患者百分比。进行非劣效性检验以比较MVC组和PICC组不良事件或功能障碍的比例。非劣效性界值设定为10%,单侧显著性水平为5%。

结果

在转诊至三级医疗中心进行PICC置管的6821例患者中,294例(180例男性[61.2%];年龄中位数[四分位间距]为56.3[38.2 - 66.7]岁)被随机分配接受MVC(n = 146)或PICC(n = 148);排除未完成随访的患者后,分别有135例和137例参与者纳入数据分析。MVC组135例患者中有90例(66.7%)、PICC组137例患者中有128例(93.4%)无VC相关不良事件或功能障碍。MVC的非劣效性未得到证实(非劣效性检验P > 0.99)。

结论和相关性

在这项随机临床试验中,MVC组中出现VC相关不良事件或功能障碍的患者比例显著更高,且不能证明MVC是PICC的非劣效替代方案。

试验注册

ClinicalTrials.gov标识符:NCT03502980。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f986/11926630/8e26608776b3/jamanetwopen-e251258-g001.jpg

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