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临床试验/NCT01256333
NCT01256333已完成不适用

Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)

研究概览

简要总结

Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this affection keep an elevate rate of death. The strategy of mechanical ventilation is more and more under definite protocol, following large strength randomized studies. Although, it doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure (PEEP) with improvement in patient's survival.

The investigators proposed in this study to determinate the level of PEEP adjust to obtain the better arterial oxygen transport (TaO2). The investigators going to conduct a physiologic, observational, none controlled study. All patients hospitalized in intensive care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion criteria will be included. Primary objective is to looking for the optimum level of PEEP for TaO2.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • patient presenting a Acute Respiratory Distress Syndrone (ARDS) definite by : acute respiratory failure, bilateral alveolo-interstitial infiltrate on chest radiography, absence of increased left ventricular filling pressure, partial pressure of oxygen in arterial blood (PaO2)/Fraction of inspired oxygen(FiO2) <200 and Positive End-Expiratory Pressure (PEEP) > or equal to 5 cmH2O
  • Need to invasive mechanical ventilation
  • Precedent criteria persisting at least 6 hours
  • Haemoglobin > 8g/dl
  • Ramsay score at 6

排除标准

  • Participation to en other study on the Acute Respiratory Distress Syndrone (ARDS) with the same end-point
  • Presence of external circulatory assist
  • Left Ventricular Ejection fraction (LVEF)or Left ventricular shortening fraction (LVSF)< 40% after correction of hypovolemia and/or vasoplegia
  • Infusion of inotrope
  • Presence of Acute Pulmonary Heart
  • Following procedure : ExtraCorporeal Membrane Oxygenation(ECMO), prone position, inhalation of Nitrogen dioxyde
  • Presence of a chest tube
  • Pregnant or nursing mother
  • Less than 18 years old
  • Complete arrhythmia by atrial fibrillation
  • Person under justice protection

结局指标

主要结局

Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)

时间窗: 1 year

次要结局

  • Evolution of pulmonary gas exchanges(1 year)
  • Evolution of respiratory mechanism parameters(1 year)
  • evolution of circulatory parameters and needs of catecholamine during the study(1 year)
  • Appearance of secondary effects due to mechanical ventilation(1 year)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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