Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- percentage of patient who obtained a safe ultraprotective ventilation
研究概览
简要总结
The extracorporeal CO2 removal (ECCO2R) has been recently proposed in case of Acute Respiratory Distress Syndrome (ARDS) in order to reduce pulmonary injuries induced by the mechanical ventilation. A reducing of tidal volume and/or respiratory rate is thus expected using this extracorporeal respiratory support. However, most of existing devices of ECCO2R can apply only a limited extracorporeal flow, often less than 1L/min, which limits the CO2 exchanges and does not allow to reach an ultraprotective ventilation. An extracorporeal flow higher should logically maximalize CO2 removal and allow reducing intensity of mechanical ventilation. Works focused on high-flow ECCO2R (2-3 L/min) in setting of ARDS are therefore mandatory to better understand apprehend the phenomena of gazes changes with this device and confirm the added-value in management of these specific patients.
详细描述
This is a prospective interventional study focused on a cohort population.
The included patients will be those affected by a severe ARDS (Berlin definition) requiring an aggressive mechanical ventilation and whom a high-flow ECCO2R was implemented.
The high-flow ECCO2R will be proposed in all patients with inclusions criteria with the 15 first days following their admission. The day of initiation of the high-flow ECCO2R will considered as Day 0 in our study.
A data collection will be focused on the respiratory parameters, clinical complications until ICU discharge and outcome, extracted from medical records.
The main endpoint will be the perrcentage of patients whom an ultraprotective ventilation could be applied successfully during more than 12h. Ultraprotective ventilation is defined in our work as follows: Tidal volume ≤ 3 mL/kg and respiratory rate ≤ 16/min associated with a PaCO2 ≤ 45mmHg and a PaO2 ≥ 55 mmHg.
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
- •Aged from 18 years old
- •Patient suffering from ARDS including the 3 following parameters during more than 12 hours:
- •PaO2/FiO2 ≤200 Driving Pressure ≥15 cmH2O, Tidal Volume = 6 mL/kg PIT Respiratory rate ≥ 28/min
- •Or patient hospitalized for severe bronchospasm or COPD exacerbation associating a persistent capnia ≥ 50 mmHg despite maximal mechanical ventilation (Vt = 6mL/kg PIT, respiratory rate ≥ 24/min)
排除标准
- •Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
- •Consent refusal from the patient or his/her next of kin and the impossibility to enrol using the emergency procedure
- •Pregnant or breast feeding patient
- •Absence of a French Health Care Insurance coverage
结局指标
主要结局
percentage of patient who obtained a safe ultraprotective ventilation
时间窗: 12 hours
a safe ultraprotective ventilation is defined by the four following parameters : 1. Tidal Volume ≤ 3 mL/kg 2. Respiratory Rate ≤ 16/min 3. PaCO2 ≤ 45mmHg 4. PaO2 ≥ 55 mmHg.
次要结局
- Hospital length of stay(up to Day 30)
- ICU length of stay(up to Day 30)
- Duration of mechanical ventilation(up to Day 30)
- Day 30 all-cause mortality(up to Day 30)