Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain) (AMIS)
研究概览
详细说明
Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.
The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.
Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Nice、法国、06003
- Réanimation Médicale CHU de Nice - Hôpital de l'Archet
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Moderate to severe ARDS (Berlin Definition)
- Acute beginning <1 week
- PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
- Bilateral opacities on chest X-ray
- Respiratory failure not fully explain by cardiac failure or fluid overload
- Informed consent signed by the next of kin and secondarily by the patient when awake
- Patient with social insurance
No Inclusion criteria
- Age < 18
- Pregnancy a pregnancy test will be done to women of childbearing age
- Chronic obstructive pulmonary disease
- Severe hypoxemia PaO2/FiO2 <50% with high PEEP
- Immunosuppressive treatment
- Immunodeficiency onco-hematology, HIV
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Inflammatory markers
All patients with inclusion criteria (ARDS moderate and severe: Berlin definition) and absence of non inclusion criteria will have a broncho alveolar wash at day 0 and blood sample every three day to measure inflammatory markers.
All patients will receive protective ventilation with low tidal volume and pressures limited (Pplat <30cmH2O).
End-Expiratory Lung Volume and strain will be measured every 6 hours from the inclusion to the extubation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg
大体时间：until the 13th day
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measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13
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until the 13th day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mortality at D28
大体时间：at the 28th day
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Verify if the patient is death at the 28th day
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at the 28th day
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Ventilatory free days at D28
大体时间：at the 28th day
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To determine if the patient is free ventilatory at the 28th day
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at the 28th day
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合作者和调查者
调查人员
- 首席研究员：Jean DELLAMONICA, MD、CHU de Nice Hopital de L'Archet
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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