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临床试验/NCT04635267
NCT04635267Unknown不适用

Effects of Extravascular Lung Water on Prone Position Efficacy in Patients With Acute Respiratory Distress Syndrome

Bicetre Hospital0 个研究点目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the partial arterial pressure in oxygen over inspired fraction of oxygen (PaO2/FiO2) ratio during prone position.

研究概览

简要总结

The study will investigate the influence that extravascular lung water index (EVLWi) could have on the efficacy and persistance of efficacy of prone position in patients with acute respiratory distress syndrome.

Prone position will increase blood oxygenation in 75% of the cases and will be persistant in half of the cases. Unfortunately, no clinical criteria has been found correlated with efficacy. The quantity of lung edema, with increased lung weight, could be a determinant factor of efficacy and the persistance of the efficacy. EVLWi, assessed with the PiCCO2 device, reflects the quantity of fluid accumulated in interstitial and alveolar spaces.

The hypothesis is that patients with higher EVLWi will have less efficacy of prone position in oxygenation and also that the beneficial effects of prone position will last shorter compared to patients with lower EVLWi.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Presence of acute respiratory distress syndrome
  • Decision to perform prone position according to the physician in charge of the patient
  • Hemodynamic monitoring with a PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Allemagne)

排除标准

  • Absence of affiliation to the French Sociale security
  • Patient under a tutelage measure or placed under judicial protection
  • Known pregnancy
  • Currently receiving ECMO therapy

结局指标

主要结局

Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the partial arterial pressure in oxygen over inspired fraction of oxygen (PaO2/FiO2) ratio during prone position.

时间窗: up to 24 hours

EVLWi is the amount of water contained in the lungs outside the pulmonary vasculature. It can be measured using the transpulmonary thermodilution technique with the PiCCO2 device (Pulsion Medical Systems, Feldkirchen, Germany)

次要结局

  • Correlation between extravascular lung water index (EVLWi) at the end of prone position and the time course of the recruitment/inflation ratio in the next eight hours after prone position.(up to 24 hours)
  • Correlation between extravascular lung water index (EVLWi) just before prone position (baseline) and the time course of the recruitment/inflation ratio during prone position.(up to 24 hours)
  • Correlation between extravascular lung water index (EVLWi) at the end of prone position and the time course of the partial arterial pressure in oxygen over inspired fraction of oxygen (PaO2/FiO2) ratio in the next eight hours after prone position(up to 24 hours)

研究者

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

Christopher Lai

doctor

Bicetre Hospital

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