Physiological Effects of Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Inspiratory effort
研究概览
简要总结
The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.
In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).
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
- •Acute hypoxemic respiratory failure and PaO2/FiO2<200 mmHg
- •PaCO2<45 mmHg
- •Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload
排除标准
- •Pregnancy
- •Contraindication to helmet or facemask noninvasive ventilation
- •Contraindication to esophageal manometry
- •Contraindication to electrical-impedance tomography monitoring
- •Recent surgery involving the abdomen or the thorax
- •Pneumothorax or documented barotrauma
结局指标
主要结局
Inspiratory effort
时间窗: 1 hour
negative deflection in esophageal pressure
End-expiratory lung impedance
时间窗: 1 hour
Electrical-impedance derived end-expiratory lung volume
次要结局
- Tidal volume(1 hour)
- Discomfort(1 hour)
- Oxygenation(1 hour)
- Corrected minute ventilation(1 hour)
- Dynamic transpulmonary driving pressure(1 hour)
- Work of breathing(1 hour)
- Respiratory rate(1 hour)
- Dyspnea(1 hour)
- Pendelluft extent(1 hour)
- Compliance(1 hour)
- Arteria Carbon dioxide tension(1 hour)
- Tidal volume distribution(1 hour)