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临床试验/NCT01573715
NCT01573715Unknown4 期

Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: NIMBEX (Drug)

control group

Active Comparator

干预措施: NIMBEX (Drug)

control group

Active Comparator

干预措施: WITHOUT NIMBEX (Other)

moderate SDRA patients

Experimental

干预措施: NIMBEX (Drug)

moderate SDRA patients

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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