the Effects and Safety of the Early Application of Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVEL-APRV) Protocol and Conventional Ventilation Strategy Were Compared in ARDS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mechanical ventilation free days
研究概览
简要总结
The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
详细描述
Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.
The aim of this single-center, prospective, randomized, controlled, open study is to compare the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute respiratory distress syndrome,according to the Berlin definition of ARDS, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours
- •A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.
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)
- •Preexisting conditions with an expected 6-month mortality exceeding 50%
- •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
Mechanical ventilation free days
时间窗: day 28
次要结局
- Average dosage of sedative infusion(day 7)
- static lung compliance（ml/cmH2O）(Day 7)
- Blood pressure(mmHg)(Day 7)
- tidal volume(ml)(Day 7)
- Richmond Sedation-Agitation Scale(day 7)
- number of patients requiring the use of noninvasive ventilation(Day 28)
- peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)(day 7)
- Duration of stay in ICU(day 60)
- PaO2,PaCO2(mmHg)(Day 7)
- Duration of hospital stay(day 60)
- number of patients requiring cointerventions and Adjunctive Therapies(Day 28)
- the tracheotomy rate(Day 28)
- the number of days free from organ dysfunction(Day 28)
- minute ventilation (L)(Day 7)
- all causes mortality(day 60)
- all cause hospital mortality(day 60)
- Average dosage of vasoactive drugs each day in use(day 7)
- Number of patients with a pneumothorax(Day 28)
- blood lactic acid（mmol/l）(Day 7)
研究者
Zhou Yongfang
Principal Investigator
West China Hospital