Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Ventilator free days
研究概览
简要总结
The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.
详细描述
The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO.
The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg
- •ECMO < 24 hours in situ
- •Gender-matched
- •Age-matched
排除标准
- •BMI > 40
- •Expected weaning of ECMO < 3 days (postoperative ECMO)
- •Combustion
- •Restrictive chest wall impairment
- •Pregnancy
结局指标
主要结局
Ventilator free days
时间窗: Immediately after initiation of ECMO up to 28 days
Ventilator free days
Time from randomization to fulfillment of extubation criteria
时间窗: Immediately after initiation of ECMO up to 28 days
Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria: * ARDS resolved * Temperature ≥ 36°C and ≤ 39°C * Low FiO2 (\< 0.5) * PEEP (\< 8 cmH2O) requirement * Able to initiate spontaneous breaths * Tidalvolume \> 5 mL/kg or \> 325 mL * Minute ventilation 5-6 L/min * PaO2/FiO2 \> 200 mmHg * pH ≥ 7.25 * Ability to cough after deflating tube cuff * Respiratory rate 8-30/min * Hemodynamic stability
次要结局
- Total time of mechanical ventilation(Start of mechanical ventilation up to 28 days)
- 28 day mortality(Immediately after initiation of ECMO up to 28 days)
- One year mortality(Immediately after initiation of ECMO up to one year)
- Incidence of reintubation(Immediately after initiation of ECMO up to 28 days)
- Length of ICU stay(Immediately after initiation of ECMO)
- Evaluation of RAS, ACE, ACE2.(2 months)
- Evaluation of Cytokines in pg/ml(2 months)
- Evaluation of vitamin D status(Length of ICU stay)
研究者
Martina Hermann
Investigator
Medical University of Vienna