跳至主要内容
临床试验/NCT04131088
NCT04131088已完成不适用

"Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study"

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,000
试验地点
1
主要终点
assess numbers of adverse events

研究概览

简要总结

Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.

详细描述

The midline is a deep peripheral venous catheter whose insertion is between the lower and upper third of the arm and whose distal end does not extend beyond the axillary vein. It requires the identification of the vein by ultrasound which reserves its installation for professionals trained and authorized to use the ultrasound scanner.

Midline is currently indicated for intravenous treatments > 7 days and in patients with precarious venous capital. According to the manufacturer's instructions, it can be kept in place for up to 30 days, while the recommendations of the Centers disease of control specify that this period could be extended to 49 days.

Its use is expanding rapidly in France, thus meeting the needs of patients who do not require a central line and whose use of a standard peripheral venous catheter is not possible (low venous capital or treatment duration > 7 days). Its installation, essentially carried out by qualified anaesthetists, does not increase medical planning and is therefore an attractive alternative to the installation of a central catheter whose complications (thrombosis and infections) are known.

The only data on the complication rate, estimated at 1-2%, are from low-potency observational studies. In the absence of high-level evidence, most of the good practice recommendations published in 2019 are based on expert consensus.

This leads us to conduct a large-scale observational study to assess the complication rate and identify the associated factors. This study will provide professionals with reliable scientific data for the next review of good practice recommendations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient
  • No opposition to the study
  • Patient requiring a midline

排除标准

  • Patient in Intensive Care Unit or acute care unit.
  • Patient with a contra indication to midline insertion: arterio-venous fistula, history of axillary lymph node clearance or radiotherapy in the infusion arm, presence of infectious skin lesions near the infusion area, presence of a prosthesis on the infusion arm or hemiplegic arm.
  • Patient under legal protection measure
  • Patient already enrolled
  • Minor patient;
  • Pregnant woman.

结局指标

主要结局

assess numbers of adverse events

时间窗: through study completion, an average of 2 year

catheter related infection yes/no vein thrombosis yes/no occlusion yes/no exposition time to a midline catheter

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验