Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- Comparison of oxygen tissue partial pressure (PtiO2) values
研究概览
简要总结
This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.
详细描述
Two ARM are compared in this study:
- The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cm H2O with decrease of tidal volume (Vt) if necessary.
- The continuous positive airway pressure, or Continuous Positive Airway Pressure (CPAP) with application of a positive pressure of 40 cm H2O for 40 seconds without tidal volume.
Patients are randomized to receive in cross-over 2 ARM: CPAP and Extended Sigh (eSigh). The following data: oxygen tissue partial pressure (PtiO2), respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Patients with brain injuries (subarachnoid hemorrhage, traumatic brain injury, ischemic and hemorrhagic stroke)
- •Patients with moderate and severe ARDS criteria (as defined by classification of Berlin)
- •Patients under mechanical ventilation
排除标准
- •ICP (Intracranial pressure) > 25 mmHg
- •Pregnant women
- •Patients with history of chronic respiratory disease
- •Patients with bronchopleural fistula
- •Patients with hemodynamic instability despite appropriate measures
研究组 & 干预措施
Alveolar recruitment maneuvers Group 1
alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh
干预措施: alveolar recruitment maneuvers group 1 (Other)
Alveolar recruitment maneuvers Group 2
alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP
干预措施: alveolar recruitment maneuvers group 2 (Other)
结局指标
主要结局
Comparison of oxygen tissue partial pressure (PtiO2) values
时间窗: 60 minutes
The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP
次要结局
- Comparison of Intracranial hemodynamic parameters(60 minutes)
- Comparison of arterial blood gases(60 minutes)
- Comparison of systemic hemodynamic parameters(60 minutes)
- Comparison of blood oxygen level(60 minutes)
- Comparison of partial pressure of carbon dioxide(60 minutes)
- Comparison of PtiO2(60 minutes)
- Comparison of end-tidal CO2(60 minutes)
- Comparison of Respiratory parameters(60 minutes)