Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS
试验速览
- 阶段
- 不适用
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Therapeutic failure death or intubation
研究概览
简要总结
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.
Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.
Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.
Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.
Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected.
- •Patient treated by nasal high flow.
- •Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio <300 mmHg (or SpO2 / FiO2 equivalent).
- •Informed consent.
- •Beneficiary or affiliated to a social security scheme.
排除标准
- •Indication of immediate tracheal intubation
- •Significant acute progressive circulatory insufficiency
- •Impaired alertness, confusion, restlessness
- •Body mass index> 40 kg / m2
- •Chest trauma or other contraindication to prone position
- •Pneumothorax
- •Vulnerable person: safeguard of justice
- •Pregnant or lactating woman
结局指标
主要结局
Therapeutic failure death or intubation
时间窗: 28 days within randomization
Therapeutic failure: death or intubation
次要结局
- Efficacy of prone position in HFNC patients(28 days within randomization)
- Feasibility and safety of prone position in HFNC patients(28 days within randomization)