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临床试验/NCT04319965
NCT04319965Unknown不适用

Complications Related to Transpulmonary Thermodilution in the Intensive Care Unit and the Operating Room

Bicetre Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年2月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
To describe the incidence of transpulmonary thermodilution related complications

研究概览

简要总结

The transpulmonary thermodilution is commonly used in patients with acute circulatory failure in the intensive care unit and for monitoring surgical patients at high risk. However, the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution has not been completely reported yet.

详细描述

Transpulmonary thermodilution (TPTD) is a technique used for haemodynamic monitoring. It consists of a monitor device which is connected to two catheters. One is a catheter inserted into the superior vena cava (internal jugular or subclavian), which is a standard catheter commonly used in patients with acute circulatory failure. The other one is a thermistor-tipped arterial catheter, which is inserted through the femoral route (the tip stands in the iliac artery), which allows the measurement of blood temperature. Catheters designed for the radial, brachial and humeral arteries also exist. TPTD allows the computation of cardiac output from the thermodilution curve recorded by the thermistor-tipped femoral arterial catheter. As an advanced cardiac output monitoring technique, it provides several important haemodynamic variables. It can be used in the intensive care unit (ICU) and in the operating room (OR). Two TPTD systems are now on the market. The PiCCO2 system (Pulsion Medical Systems, member of the Getinge Group, Feldkirchen, Germany) and the VolumeView/EV1000 system (Edwards Lifesciences, Irvine, United States of America). This study is designed to investigate the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution.

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

  • Age ≥ 18 years
  • Monitoring by a TPTD system (PiCCO2 or VolumeView/EV1000) already planned or set up

排除标准

  • 未提供

结局指标

主要结局

To describe the incidence of transpulmonary thermodilution related complications

时间窗: At the time of TPTD catheters removal, an average of 7-14 days, depending on the individual situation

Systematic report of mechanical, haemorragic and infections complications

次要结局

  • Prevalence of theoretical risk factors for these complications.(Through study completion, up to 1 year)

研究者

发起方
Bicetre Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xavier Monnet

Professor Xavier Monnet MD. PhD.

Bicetre Hospital

研究点 (1)

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