Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- [PaO2 / FiO2] ratio
研究概览
简要总结
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.
Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.
Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Aged ≥ 18 years,
- •Admitted to ICU within 72 hours,
- •Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
- •Having acute hypoxemic respiratory failure with a [PaO2/FiO2] ratio between 100 mmHg and 300 mmHg,
- •Having given free and informed written consent,
- •Being affiliated with or benefiting from a social security scheme.
排除标准
- •Unable to achieve a prone position for mobility reasons,
- •Unable to achieve a prone position due to agitation whatever the cause,
- •With clinical occlusive syndrome in order to limit the risk of inhalation,
- •Having a contraindication to the use of the esophageal catheter,
- •Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
- •Having hypercapnia indicating the use of non-invasive ventilation (PaO2> 50 mmHg),
- •Having severe hypoxemia defined by PaO2 / FiO2 <100mmHg,
- •Ongoing pregnancy or breastfeeding,
- •Subject to a measure for the protection of justice.
结局指标
主要结局
[PaO2 / FiO2] ratio
时间窗: 6 hours
Oxygenation will be evaluated by the \[PaO2 / FiO2\] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.
次要结局
- ΔPeso measured using an esophageal balloon catheter(6 hours)
- Intensity of dyspnea(6 hours)
- Concentration of CO2 at the end of expiration (EtCO2, mmHg)(6 hours)
- The occurrence of side effects due to PP(6 hours)
- Tolerance of the technique(6 hours)