A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.
Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.
详细描述
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
- •receiving tracheal intubation and mechanical ventilation was no longer than 48 hours
排除标准
- •Pregnancy
- •The expected duration of mechanical ventilation was less than 48 hours
- •Intracranial hypertension (suspected or confirmed)
- •Neuromuscular disorders that are known to prolong the need for mechanical ventilation
- •Known or suspected chronic obstructive pulmonary disease(COPD)
- •Terminal stage of disease
- •Pneumothorax (drained or not)at enrollment
- •Treatment with extracorporeal support (ECMO) at enrollment
- •There was a lack of commitment to life support.
结局指标
主要结局
mortality
时间窗: Day 28
mortality at Day28
次要结局
- oxygenation(from enrollment to Day7)
- Sedative drug(during the mechanical ventilation procedure)
- successful extubation rate(during the mechanical ventilation procedure)
- Mechanical ventilation free days(Day 28)
- MAP(during the mechanical ventilation procedure)
- repiratory system compliance(from enrollment to Day7)
- sedation depth(during the mechanical ventilation procedure)
研究者
Kang Yan
Director of department of Critical Care Medicine
West China Hospital