Physiological Effects of Personalized Noninvasive Support 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
- 2
- 主要终点
- Tidal volume
研究概览
简要总结
The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals.
The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.
详细描述
Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O.
Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.
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 support
- •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
Tidal volume
时间窗: 1 hour
Tidal volume size, assessed with electrical impedance tomography
Transpulmonary driving pressure
时间窗: 1 hour
The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure
次要结局
- Inspiratory effort(1 hour)
- Work of breathing(1 hour)
- End-expiratory lung impedance(1 hour)
- Respiratory rate(1 hour)
- Blood oxygenation(1 hour)
- Corrected minute ventilation(1 hour)
- Tidal volume distribution(1 hour)
- Pendelluft extent(1 hour)
- Lung compliance(1 hour)
- Dyspnea(1 hour)