NCT01457898已完成不适用
Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Oxygenation index (PaO2/FiO2)
研究概览
简要总结
Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac patients but more studies are necessary to clarify its respiratory and hemodynamic effects. Therefore, the investigators objective was to study its effects in the oxygenation index (PaO2/FiO2) and in hemodynamic variables in this group of patients.
详细描述
- Postoperative cardiac surgery patients having a Swan-Ganz catheter and showing a PaO2/FiO2 between 150 and 300 (with FIO2 0.31), one hour after extubation, were included.
- Then, the patients were randomized into two groups: control and intervention group. Intervention group used NIV with a bi-level positive airway pressure (an inspiratory pressure to generate a tidal volume of 6ml/kg and an expiratory pressure of 7cmH2O) with a FIO2 0.4. Control group used oxygen by Venturi mask(FIO2 0.4) in order to keep a good oxygenation.
- In both groups measurements were done in basal situation, one and three hours after beginning the treatment and one hour after stop the treatment (FiO2 0.31).
- Variables studied included: PaO2/FiO2, PaO2, PaCO2, heart rate (HR), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP) and cardiac output (CO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oxygenation index (PaO2/FiO2)between 150 and 300 one hour after extubation following cardiac surgery.
- •Swan-Ganz catheter
排除标准
- •Invasive mechanical ventilation more than 24 hours
- •Serious obstructive pulmonary chronic disease (FEV1<40%)
结局指标
主要结局
Oxygenation index (PaO2/FiO2)
时间窗: 5 hours
次要结局
- Heart rate (HR)(5 hours)
- Mean arterial pressure (MAP)(5 hours)
- Pulmonary capillary wedge pressure (PCWP)(5 hours)
- Cardiac output (CO)(5 hours)
研究者
Alessandra Preisig
Principal Investigator
Irmandade Santa Casa de Misericórdia de Porto Alegre
研究点 (2)
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