NCT02816359已完成不适用
Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Total End-expiratory esophageal pressure
研究概览
简要总结
Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress SyndromeARDS patients in order to set ventilator settings. There might be variations of the measured value according to the patient position (0° vs 30°) at the time of measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Acute respiratory failure defined by PaO2/FIO2< 300 mmHg or pH<7,35 and pCO2>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by:
- •New or worsening respiratory symptoms in the previous week.
- •Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules
- •Respiratory failure not fully explained by cardiac failure or fluid overload
- •PaO2/FIO2< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight
- •Patient intubated or tracheotomized and receiving mechanical ventilation
- •Indication of esophageal measurement decided by the clinician
排除标准
- •Contraindication to naso-gastric tube insertion :
- •Recent gastro-duodenal ulcer
- •Stage III esophageal varices
- •Refractory intracranial hypertension
- •Unstabilized spine fracture
- •Surgical contraindication
- •Burns on more than 20 % of the body surface
- •Underlying disease with a life expectancy of less than one year
- •End-of-life decision before inclusion
- •Pregnant or breast-feeding patients
- •Subject deprived of freedom, minor, subject under a legal protective measure
- •Research team unavailability
- •Lack of medical care plan
研究组 & 干预措施
head-bed position
Other
Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes
干预措施: head-bed position (Other)
结局指标
主要结局
Total End-expiratory esophageal pressure
时间窗: 30min after change of position
After end-expiratory pause on the ventilator, absolute value of the esophageal pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )
次要结局
- End-inspiratory esophageal pressure(30min after change of position)
- Gastric pressure(30min after change of position)
- End-expiratory lung volume(30min after change of position)
研究者
研究点 (2)
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