跳至主要内容
临床试验/NCT04929873
NCT04929873Unknown不适用

Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
1
主要终点
Incidence of ischemia Incidence of ischemia

研究概览

简要总结

Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.

详细描述

It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice.

Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Age: adult patients ≥ 18 years of age;
  • •signed ECMO informed consent;
  • •femur vein VA-ECMO treatment;
  • •agreed to establish VA-ECMO side branch cycle;
  • •informed consent to this study.

排除标准

  • •a completely closed double lower limb venously before surgery;

研究组 & 干预措施

routine treatment

Placebo Comparator

routine nursing

干预措施: Routine monitor (Behavioral)

Experimental group

Experimental

Immediately after the establishment of the side branch cycle, the closed transdone is connected for real-time monitoring of pressure, and clinical nursing practice is guided by transdictor pressure.

干预措施: Closed transdyser (Behavioral)

结局指标

主要结局

Incidence of ischemia Incidence of ischemia

时间窗: 1 year

of ischemia in the lower extremities on the side of the tube

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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