NCT07714564尚未招募不适用
Tracheal High-flow vs. Conventional Oxygen for Weaning From Mechanical Ventilation in Tracheostomized Patients: an Open-label, Multicentre, Randomized Trial
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Succesful weaning
研究概览
简要总结
Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Tracheostomy
- •Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation
- •Hypoxemia (PaO2/FiO2<300) while on mechanical ventilation
排除标准
- •anticipated need for long-term mechanical ventilation
- •scheduled reconnections to mechanical ventilation
- •neuromuscular disease
- •chronic ventilator dependence
- •planned nocturnal home ventilation
结局指标
主要结局
Succesful weaning
时间窗: Day 7 after randomization
proportion of patients weaned from mechanical ventilation at day 7 after randomization. Weaning is defined as being disconnected from the mechanical ventilator on day 7 and remaining off the ventilator for at least the subsequent 48 consecutive hours without reconnection.
次要结局
- Succesful weaning - Day 28(Day 28 after randomization)
- Time to successful weaning from mechanical ventilation(90 days)
- Number of reconnections required to the ventilator(90 days)
- Mechanical ventilation-free days(Day 28, 60 and 90)
- Intensive care unit-free days(Day 28, 60 and 90)
- In-intensive care unit mortality(90 days)
- In-hospital care unit mortality(90 days)
- 90-day mortality(90 days)
- Pneumonia(90 days)
- Shock(90 days)
- Time to decannulation(90 days)
研究者
研究点 (1)
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