Physiological Effects of High Flow Oxygen Therapy Using 'Optiflow + Duet' Interface vs 'Standard' High Flow Nasal Cannula for Acute Respiratory Failure After Extubation. The OPTIMARF Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Breathing effort
研究概览
简要总结
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.
详细描述
A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •age >18 years old;
- •invasive mechanical ventilation > 24h;
- •acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio < 300;
- •absence of Sars-Cov-2 positivity;
- •absence of cardiological or long-term respiratory disease
排除标准
- •pregnancy
- •tracheostomy
- •non-invasive ventilation after extubation
- •second tracheal intubation
- •contraindications for EIT belt
- •facial or nose abnormalities
结局指标
主要结局
Breathing effort
时间窗: Last 10 minutes of 1 hour-trial
To evaluate changes, between arms, in breathing effort (as assessed by diaphragm ultrasound (DUS)).
Lung aeration
时间窗: Last 10 minutes of 1 hour-trial
To evaluate changes, between arms, in lung aeration (as assessed by the end-expiratory lung impedance (delta EELI) through EIT.
次要结局
- Minute ventilation (MV) (L/min)(Last 10 minutes of 1 hour-trial)
- corrected MV (L/min)(Last 10 minutes of 1 hour-trial)
- Breathing heterogeneity(Last 10 minutes of 1 hour-trial)
- Dyspnea(Last 10 minutes of 1h-trial)
- Comfort(Last 10 minutes of 1h-trial)
- Gas exchange(Last 10 minutes of 1h-trial)