Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in driving pressure
研究概览
简要总结
Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •invasive mechanical ventilation
- •ARDS (Berlin definition) with PaO2/FiO2 ratio ≤ 150 mm Hg
排除标准
- •Age below 18 year
- •planned duration of invasive mechanical ventilation < 48 hours
- •ARDS criteria present for more than 24 hours
- •known or suspected intracranial hypertension
- •known or suspected COPD
- •chronic respiratory failure under long term oxygen or non-invasive ventilation
- •pneumothorax or broncho-pleural fistula
- •morbid obesity with body weight >1 kg/cm height
- •sickle cell disease
- •recent bone marrow transplantation, aplasia following chemotherapy
- •burn injury on more than 30% of body surface
- •severe hepatic cirrhosis (Child-Pugh score C)
- •extracorporeal circulation life support
- •pregnancy
- •advance directives to withhold or withdraw life-sustaining treatment
- •previous inclusion in present study
- •patient under an exclusion period following inclusion in another biomedical study
- •patient deprived of freedom, minor, subject under a legal protective measure
- •lack of affiliation to social security as required by French regulation
- •lack of written informed consent by patient or next of kin
研究组 & 干预措施
Tidal volume 4 ml/kg Predicted Body Weight (PBW)
干预措施: Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW) (Other)
结局指标
主要结局
Change in driving pressure
时间窗: Baseline and 24 hours following inclusion
Driving pressure is the difference between total respiratory system plateau pressure minus total positive end-expiratory pressure (PEEP)
次要结局
- Rate of pneumothorax(Day 90)
- Change in right ventricule/left ventricule area(Baseline and 24 hours following inclusion)
- Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight(48 hours following inclusion)