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非 ICU 患者中线导管随访的并发症和危险因素：一项多中心观察性研究（midDATA 研究）的研究方案。

Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study).

机构信息

Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Unité d'accès vasculaires (UnAV), Hôtel Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France

Nantes Université, Université de Tours, CHU Nantes, INSERM UMR 1246 Methods in Patients-Centered Outcomes and Health Research, Nantes, France.

出版信息

BMJ Open. 2023 Jul 18;13(7):e067796. doi: 10.1136/bmjopen-2022-067796.

DOI:10.1136/bmjopen-2022-067796
PMID:37463802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10357646/
Abstract

INTRODUCTION

The midline catheter (MC) is an increasingly popular device used commonly for patients with difficult venous access or those who require infusion for more than 6 days. Little is known about complications such as infection, thrombosis or occlusion for inpatient and home care patient. This protocol presents the follow-up of non-intensive care unit patients with an MC. The aim is to identify complications and search for risk factors associated with these complications.

METHOD AND ANALYSIS

A prospective observational design is used for the follow-up of 2000 patients from 13 centres in France. Each practitioner (inserting clinician, anaesthetist nurse, hospital nurse and home nurse) will fill out a logbook to report each care made (eg, number of saline flushes, dress maintenance) on the MC and if any complications occurred. The incidence of complications (ie, infections, thrombosis or occlusions) will be expressed by the total number of events per 1000 catheter days. The period of recruitment began in December 2019 for a duration of 2 years. An extension of the inclusion period of 1 year was obtained.

ETHICS AND DISSEMINATION

This study received the approval of the Committee for the Protection of Persons of Nord Ouest IV (No EudraCT/ID-RCB : 2019-A02406-51). It was registered at clinical trials (NCT04131088). It is planned to communicate results at conferences and in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

NCT04131088.

摘要

简介

中线导管（MC）是一种越来越受欢迎的装置，常用于静脉穿刺困难或需要输液超过 6 天的患者。对于住院和家庭护理患者，有关感染、血栓形成或闭塞等并发症的信息知之甚少。本方案介绍了对非重症监护病房患者使用 MC 的随访。目的是确定并发症并寻找与这些并发症相关的危险因素。

方法和分析

采用前瞻性观察设计，对法国 13 个中心的 2000 名患者进行随访。每位医生（置管医生、麻醉护士、医院护士和家庭护士）将填写病历，报告对 MC 进行的每次护理（例如，生理盐水冲洗次数、敷料维护），以及是否发生任何并发症。并发症（即感染、血栓形成或闭塞）的发生率将通过每 1000 个导管日发生的总事件数来表示。招募期于 2019 年 12 月开始，为期 2 年。已获得纳入期延长 1 年的批准。

伦理和传播

本研究得到了 Nord Ouest IV 保护委员会的批准（EudraCT/ID-RCB 编号：2019-A02406-51）。它已在临床试验中注册（NCT04131088）。计划在会议和同行评议期刊上交流结果。

试验注册号

NCT04131088。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2504/10357646/6395566ae8c9/bmjopen-2022-067796f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2504/10357646/0191928841db/bmjopen-2022-067796f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2504/10357646/6395566ae8c9/bmjopen-2022-067796f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2504/10357646/0191928841db/bmjopen-2022-067796f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2504/10357646/6395566ae8c9/bmjopen-2022-067796f02.jpg

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Safety and Outcomes of Midline Catheters vs Peripherally Inserted Central Catheters for Patients With Short-term Indications: A Multicenter Study.短期适应证患者中线导管与经外周置入中心静脉导管安全性和结局的多中心研究。
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