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临床试验/NCT04155723
NCT04155723已完成不适用

Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters

Groupe Hospitalier de Bretagne Sud1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2019年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
310
试验地点
1
主要终点
Duration of exposure to central venous catheter

研究概览

简要总结

The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. These features make it a good alternative to central venous and conventional peripheral venous catheters.

Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters. The aim of the study is to increase the use of Midlines in the unit to reduce the exposure to central venous catheters and their complications, such as infections or thrombosis.

The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines'use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis.

详细描述

The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Although central venous catheters (CVC) are often mandatory in ICU, the risk of catheter-related infections should lead to consider the insertion of peripheral venous catheters. However in ICU patients, presence of edema or poor venous condition may not allow placement of peripheral venous catheter.

Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days (according to manufacturer recommendations). These features make it a good alternative to central venous and conventional peripheral venous catheters. They are placed at the bedside, peripherally into the cephalic or basilic vein, with the tip reaching the axillary vein.

Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. Studies have shown the feasibility and the safety of delegating to nurses placement of CVC and Midlines. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters.

Midlines' implementation has been associated with a decrease in the use of CVC and catheter-related infections. To our knowledge, no study investigated the placement of Midlines by nurses in the ICU.

The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines' use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis. Complications related to Midlines' placement would also be recorded.

研究设计

研究类型
Observational
观察模型
Case Control
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 patients hospitalized in ICU for more than 48 hours

排除标准

  • Patient under 18 years old
  • Patient under legal guardianship
  • Absence of health insurance in France
  • Refusal of the patient or his next-of-kin
  • Patient with a decision of withholding or withdrawing of life sustaining therapy
  • Patient with a subcutaneous central venous port
  • Impossibility of infusion on the upper limbs

结局指标

主要结局

Duration of exposure to central venous catheter

时间窗: ICU discharge (usually seven days)

Duration of exposure to central venous catheter (catheter-days per patient-day)

次要结局

  • Number of catheter-related thrombosis(Hospital discharge (usually two weeks))
  • Description of the events associated with Midlines' insertion : Duration of the procedure(ICU discharge (usually seven days))
  • Duration of exposure to peripheral venous catheter(ICU discharge (usually seven days))
  • Duration of exposure to Midline(ICU discharge (usually seven days))
  • Number of catheter-related infections(Hospital discharge (usually two weeks))
  • Number of pneumothorax and arterial punctures(ICU discharge (usually seven days))
  • Number of patients discharged from the ICU with a central venous catheter(ICU discharge (usually seven days))
  • Description of the events associated with Midlines' insertion : Number of punctures(ICU discharge (usually seven days))
  • Description of the events associated with Midlines' insertion : Failure rate(ICU discharge (usually seven days))

研究者

发起方
Groupe Hospitalier de Bretagne Sud
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Bouju

Principal Investigator

Groupe Hospitalier de Bretagne Sud

研究点 (1)

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