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临床试验/NCT05474196
NCT05474196招募中不适用

Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS

Bicetre Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)

研究概览

简要总结

Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. However, these airway pressures might not reflect the actual pressure applied to the lung. Transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (VILI).

One of the consequences of the VILI is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution.

So it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.

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

  • Acute respiratory distress syndrome (ARDS)
  • Monitoring with a transpulmonary thermodilution device
  • Esophageal pressure monitoring

排除标准

  • Legal protection measures
  • Pregnancy
  • Contra-indications of esophageal catheter : esophageal varicose, severe coagulopathy

结局指标

主要结局

Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)

时间窗: From inclusion up to hospital discharge (maximum day 60)

On the first day of patient's respiratory and hemodynamics monitoring, we will collect transpulmonary driving pressure and extra-vascular lung water values. We will calculate the correlation coefficient linking these two variables to assess if their association.

次要结局

  • Correlation between the extravascular lung water at admission and the ICU-mortality(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure on transpulmonary pressure(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure(From inclusion up to hospital discharge (maximum day 60))
  • Correlation between the transpulmonary driving pressure at admission and the ICU-mortality(From inclusion up to hospital discharge (maximum day 60))
  • Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure on intra-abdominal pressure(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure on esophageal pressure(From inclusion up to hospital discharge (maximum day 60))

研究者

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

Tai PHAM

Principal Investigator

Bicetre Hospital

研究点 (1)

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