Prevention of Post-extubation Respiratory Failure in High Risk Patients by High-flow Conditioned Oxygen Therapy Versus Standard Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Respiratory failure after extubation
研究概览
简要总结
Failure of extubation after mechanical ventilation is a frequent and deleterious issue. Main reasons for failure are hypoxemia, secretions retention, lung collapse and excessive work of breathing. Most of this issues can be partly counterbalanced by a device named "High flow conditioned oxygen therapy (HFCO)". Then, our hypothesis is that HFCO may reduce the incidence of respiratory failure after extubation in patients with high risk for failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients mechanically ventilated for > 48 hours and at least one of the following:
- •>65 years
- •cardiac failure as the primary indication of mechanical ventilation
- •Chronic Obstructive Pulmonary Disease
- •Severity score (APACHE II >12 points) the extubation day
- •Body Mass Index >30
- •inability to manage respiratory secretions
- •1 failed spontaneous breathing trial
- •1 comorbidity
- •7 days under mechanical ventilation
排除标准
- •<18 years
- •tracheotomized patients
- •recent facial or cervical trauma/surgery
- •active gastro-intestinal bleeding
- •lack of cooperation
- •patients with any failed spontaneous breathing trial because of hypercapnia development.
结局指标
主要结局
Respiratory failure after extubation
时间窗: 72 hours
Severe hypoxemia (PaO2/Fraction of inspired O2 \< 200), hypercapnia (PaCO2 \> 50), respiratory acidosis (arterial pH \< 7.30), severe tachypnea (\>40x')
次要结局
- Survival(90 days)
研究者
Rafael Fernandez
Head of Intensive Care Department
Althaia Xarxa Assistencial Universitària de Manresa