The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mechanical Power reduction.
研究概览
简要总结
Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •ARDS patients undergoing mechanical ventilation with:
- •PaO2/FiO2 <150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 > 0.5
- •Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight
- •Mechanical power of 18 J/min or higher.
排除标准
- •<18 years of age
- •Pregnancy
- •Obesity with BMI> 30
- •Platelets <30 G/l
- •Decompensated heart failure or acute coronary syndrome
- •Acute brain injury
- •Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery)
- •Patient moribund, decision to limit therapeutic interventions
- •Catheter access to femoral vein or jugular vein impossible
- •Pneumothorax.
结局指标
主要结局
Mechanical Power reduction.
时间窗: Changes from baseline to day 5.
Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg. Mechanical Power (MP) (J/min) = 0.098 \* respiratory rate \* tidal volume (inspiratory peak airway pressure - 1/2 \* (airway pressure at end inspiratory pause - airway pressure at PEEP))
次要结局
- Gas exchange.(Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days)
- Respiratory mechanics.(Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days)
- Safety assessment and adverse device related events: frequency of serious adverse events(Every day, until the fifth day or until the weaning from ECCO2R if lower than five days)
研究者
Davide Chiumello
Professor
University of Milan