Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Treatment Failure (Intubation or Death)
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in Wuhan, China, and had subsequently spread worldwide. Twenty-nine percent of COVID-19 patients may develop ARDS. Based on the potential beneficial mechanisms of HFNC and PP, whether early use of prone positioning combined with HFNC can avoid the need for intubation in COVID-19 induced moderate to severe ARDS patients needs to be further investigated.
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
- 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 induced adult ARDS patients admitted to the medical ICU
- •PaO2/FiO2 is less than 200mmHg or FIO2 ≥ 0.4 is required to maintain SpO2 at 88-93% on HFNC treatment
排除标准
- •If the patients have a consistent SpO2<80% when on evaluation with a FiO2 of 0.6, or signs of respiratory fatigue (RR > 40/min, PaCO2> 50mmHg / pH<7.30, and obvious accessory respiratory muscle use);
- •Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect airway or mental status change);
- •unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for vasopressor);
- •unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
- •chest trauma or any contraindication for PP
- •pneumothorax
- •age < 18 years
研究组 & 干预措施
high flow nasal cannula only
Receive high flow nasal cannula only
干预措施: high flow nasal cannula (HFNC) (Device)
HFNC plus prone positioning
Receive high flow nasal cannula plus prone positioning
干预措施: high flow nasal cannula (HFNC) (Device)
HFNC plus prone positioning
Receive high flow nasal cannula plus prone positioning
干预措施: Prone positioning (PP) (Procedure)
结局指标
主要结局
Treatment Failure (Intubation or Death)
时间窗: 28 days
the treatment failure rate of HFNC/HFNC+PP support within 28 days of study enrollment
Number of Participants With Intubation
时间窗: 28 days
intubation rate of HFNC/HFNC+PP support within 28 days of study enrollment
Mortality
时间窗: 28 days
mortality of HFNC/HFNC+PP support within 28 days of study enrollment
次要结局
- Number of Participants With Adverse Events(28 days of study enrollment)