跳至主要内容
临床试验/NCT05741918
NCT05741918招募中不适用

Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography

研究概览

简要总结

Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.

The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
28 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient under 18 years old
  • Patient over 10 kg
  • Patient requiring intubation or intubated with a cuffed tube
  • Patient requiring a central venous line in superior vena cava territory

排除标准

  • Mechanical ventilation with leak
  • Bad echogenicity preventing echocardiography
  • Absence of written informed consent
  • Patient not affiliated to French Health Insurance or not covered by public health insurance
  • Patient with a legal protection

结局指标

主要结局

Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography

时间窗: Up to day 3

次要结局

  • Adverse events on the day of catheter removal(Up to 21 days)
  • Variations of cardiac output before and after Leg Raise Test(Up to day 3)
  • Adverse events on the day of catheterization(Up to 21 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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