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临床试验/NCT05412108
NCT05412108已完成不适用

Prospective Evaluation of Complications of MidLine Catheters in the ICU

Centre Hospitalier le Mans2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2022年2月17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
148
试验地点
2
主要终点
Describe the incidence of severe complications associated with the use of CMs in ICUs

研究概览

简要总结

Midline catheters (MCs) are peripheral catheters inserted into a vein in the arm above the elbow crease, with the tip in the axillary vein. As such, they do not enter the central venous circulation and are therefore not considered central venous catheters.

The main complications associated with CM are accidental removal, leakage, subcutaneous diffusion and occlusion. Severe complications include deep vein thrombosis (DVT) and catheter-related bacteremia (CRB). There is very little data on the use of CMs in intensive care units (ICU).

Resuscitation patients are more likely to develop severe catheter-related complications such as deep vein thrombosis and catheter-related infections. While the use of CMs in patients appears to be associated with a low risk of complications, this may not be the case in resuscitation patients.

Investigator therefore proposes to conduct a prospective observational study to determine the frequency and type of complications associated with CMs when they are implanted and used in ICU. In addition, investigator will attempt to determine whether risk factors predictive of complications can be identified. In addition, this study will evaluate whether the use of CMs can reduce the duration of central venous catheter maintenance in the ICU and the risk of central venous catheter-related infections.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • ICU Hospitalization
  • Indication for MidLine catheter placement during the stay

排除标准

  • Minor or protected adult
  • Pregnant woman
  • Local contraindication to the placement of a CM
  • Local infection
  • Venous thrombosis
  • Existing arteriovenous fistula or vascular network to be protected for a fistula for chronic dialysis
  • Paralysis of the limb
  • Need for administration of contraindicated solutions on the peripheral venous route:
  • Catecholamines: Noradrenaline, adrenaline (dose greater than 0.2µg/kg/min)
  • Total parenteral nutrition
  • Glucose solutions at a concentration >20
  • Potassium at a concentration >0.1mEq/ml
  • Vesicants
  • Fluids with pH <5 or >9

结局指标

主要结局

Describe the incidence of severe complications associated with the use of CMs in ICUs

时间窗: From midline catheter placement to hospital discharge (up to 28 days)

The severe complications identified will be symptomatic deep vein thrombosis, symptomatic pulmonary embolism, catheter-related infections

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 (2)

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