Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
研究概览
简要总结
This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.
详细描述
Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Mechanical ventilation with expected duration of >24 hours
- •Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O
排除标准
- •Age <18 years
- •Pregnancy
- •Severe hypoxemia with PaO2/FiO2 <100 mmHg
- •Body mass index > 40 kg/m2
- •Decompensated heart insufficiency or acute coronary syndrome
- •Severe Chronic obstructive pulmonary disease (COPD)
- •Major respiratory acidosis with PaCO2 >60 mmHg
- •Acute brain injury
- •Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure
- •Heparin-induced thrombocytopenia
- •Contraindication for systemic anticoagulation
- •Patient moribund, decision to limit therapeutic interventions
- •Catheter access to femoral vein or jugular vein impossible
- •Pneumothorax
- •Platelet <50 G/L
- •Lacking consent
结局指标
主要结局
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
时间窗: 24 hours
Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
次要结局
- Assessment of changes in respiratory rate(24 hours)
- Assessment of changes in Vt(24 hours)
- Assessment of changes in Plateau Pressure(24 hours)
- Assessment of changes in Positive End-Expiratory Pressure, PEEP(24 hours)
- Change in vasopressor use(24 hours)
- Evaluation of lung recruitment/derecruitment(24 hours)
- Lifetime of the extracorporeal circulation(7 days)
- Number of participants with adverse events directly related to ECCO2R(7 days)
研究者
Alain COMBES
Professor of Intensive Care Medicine, MD, PhD
Groupe Hospitalier Pitie-Salpetriere