Evaluation of Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation in Intensive Care Unit: A Comparative Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evolution of airway resistance before and after sevoflurane in COPD patients
研究概览
简要总结
Prospective, open-label, single-center, study to investigate the effect of sevoflurane sedation compared to a propofol-controlled arm during COPD exacerbation requiring invasive mechanical ventilation in ICU.
Primary outcome measure:
Evolution of airway resistance before and after sevoflurane in COPD patients,
Secondary outcomes measures:
Respiratory mechanics (Maximum pressure, PEEPi and PEEPtot, trapped volume), Gas exchange by the help of blood gases, The heterogeneity of alveolar ventilation by electro-impedancemetry, Evolution of pulmonary inflammation, Trophicity and contractility of the diaphragm,
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sevoflurane group
干预措施: Sevoflurane (Drug)
Sevoflurane group
干预措施: Propofol (Drug)
Propofol group
干预措施: Propofol (Drug)
结局指标
主要结局
Evolution of airway resistance before and after sevoflurane in COPD patients
时间窗: Hour 48
Total airway resistance will be measured using the ventilator by setting a 5s inspiratory pause and to measure the sum of (Pmax-P1)/Flow + (P1-Pplat)/Flow. The mechanical ventilation setting will be standardised during the study period and will be similar between the two groups.
次要结局
- Maximum pressure(Evolution between Hour 0 and Hour 48)
- PEEPi(Evolution between Hour 0 and Hour 48)
- PEEPtot(Evolution between Hour 0 and Hour 48)
- Heterogeneity of alveolar ventilation by electro-impedancemetry(Evolution between Hour 0 and Hour 48)
- Thickness of the diaphragm measured by ultrasound(Evolution between Hour 0 and Hour 48)
- Trapped volume(Evolution between Hour 0 and Hour 48)
- Gas exchange by the help of blood gases(Evolution between Hour 0 and Hour 48)
- Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages(Evolution between Hour 0 and Hour 48)