Prospective, Open, Uncontrolled, Non-randomized and Monocentric Trial on the Efficacy and the Inflammatory Effects of a Lung Recruitment Manoeuvre in Mechanical Ventilated Patients With Respiratory Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
研究概览
简要总结
Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung.
This study aims to determine the safety and efficacy of a recruitment manoeuvre, by considering its impact on gas exchange, hemodynamics and on the release of systemic inflammatory mediators.
详细描述
This prospective study will analyse the effects of a single recruitment manoeuvre in critically ill patients. Subjects will be mechanically ventilated patients needing alveolar RMs. After a period of stable lung protective approach ventilation, they will receive the "40/30" RM; lung mechanics, gas exchange, hemodynamics and plasmatic concentration of inflammatory mediators will be obtained before and after the RM. An ultrasound score, established from the lung aeration status of upper and lower parts of anterior and lateral chest wall, will also be calculated before and after the manoeuvre.In selected patients cytokine release in the bronchoalveolar lavage will be measured as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Mechanical Ventilation
- •Arterial catheter inserted
- •Hypoxemic respiratory failure (Pa02/FiO2 <300)
- •Radiological evidence of atelectasis or pulmonary infiltrates in the CXR
- •Informed consent
排除标准
- •Elevated intracranial pressure >25 mmHg
- •Bronchopulmonary fistula
- •Emphysema
- •Kidney or Liver failure
结局指标
主要结局
Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
时间窗: T0 (baseline), T4 (3 hrs), T5 (12 hrs)
Plasmatic concentration of Nitric Oxide
时间窗: T0 (baseline), T6 (24 hrs)
Echographic score of lung aeration
时间窗: T0 (baseline), T2 (1 hr), T4 (3 hrs)
Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)
时间窗: T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs)
Chest X-Ray
时间窗: T6 (24 hrs)
次要结局
- Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage(T0 (baseline), T4 (3 hrs))