Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
研究概览
简要总结
Prone positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality.
Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
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, either confirmed by SARS-CoV-2 assay, or clinically suspected, with results of the assay pending;
- •Lung infiltrates documented on chest X-ray or chest CT-scan;
- •Significant respiratory distress that requires treatment with HFNO.
排除标准
- •Unable to consent;
- •Unable to prone;
- •Indication for immediate endotracheal intubation and mechanical ventilation;
- •Contraindication to prone positioning (severe obesity, abdominal wound, pregnancy, unstable pelvic/spinal lesions, vomiting, etc.);
- •Comfort care or imminent expectation of death.
研究组 & 干预措施
Awake prone positioning
Prone positioning of patients on nasal high-flow oxygen therapy
干预措施: Awake Prone Positioning (Procedure)
Standard care
Standard decubitus positioning of patients on nasal high-flow oxygen therapy
干预措施: Standard care (Procedure)
结局指标
主要结局
Rate of Therapeutic failure, defined as a combined outcome of rate of intubation or death
时间窗: Up to 28 days after randomization
次要结局
- Mortality(Up to 28 days after randomization)
- Days spent on mechanical ventilation(Until discharge, up to 24 weeks after randomization)
- Hospital stay (in days)(From admission to discharge, up to 24 weeks after randomization)
- Days spent in the ICU(Until discharge, up to 24 weeks after randomization)
- Intubation rate(Up to 28 days after randomization)
研究者
Ivan Pavlov
Emergency physician
Hôpital de Verdun