Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Delta TPP
研究概览
简要总结
Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:
- reduction of the consumption of oxygen linked to ventilatory workload;
- increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
- anti-inflammatory effect contributing to a reduction in pulmonary inflammation and improvement in oxygenation,
- reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.
The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.
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
- •Early (< 48H) Severe ARDS: PaO2 / FiO2 ratio < 150 with PEEP >= 5 cmH20
排除标准
- •Age < 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube
研究组 & 干预措施
severe ARDS patients
干预措施: NIMBEX (Drug)
control group
干预措施: NIMBEX (Drug)
control group
干预措施: WITHOUT NIMBEX (Other)
moderate SDRA patients
干预措施: NIMBEX (Drug)
moderate SDRA patients
干预措施: WITHOUT NIMBEX (Other)
结局指标
主要结局
Delta TPP
时间窗: 27 months
Reduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients
次要结局
未报告次要终点
