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临床试验/NCT02387437
NCT02387437Unknown不适用

Evaluation of Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome

Southeast University, China1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
93
试验地点
1
主要终点
oxygenation (improvement of oxygenation)

研究概览

简要总结

Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.

详细描述

Acute respiratory distress syndrome (ARDS) is the common disease in clinical,which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.

Electrical impedance tomography (EIT) has been introduced as a true bedside and radiation-free technique which provides information on heterogeneity. The investigators compare effects of three recruitment maneuvers on lung heterogeneity before recruitment maneuver and do the same thing after three recruitment maneuvers.

Ninety-three patients with ARDS will be enrolled . These patients are treated routinly.They need to recept a time of ZEEP (PEEP is zero cmH2O)for ten respiratory cycles before RM(recruitment maneuvers).Implemente a kind of RM at random immediately after ZEEP,Then make the ventilator same as before ZEEP.The EIT images ,blood gases and hemodynamic variables will be examined as beseline between ZEEP and RM.Completion of this kind of RM lies that the P/F of blood gases 3 minutes after RM achieves (1) PO2/FiO2>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1),(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2<5%.In addition,3 minutes after RM,compare the indexs above between three methods.

研究设计

研究类型
Interventional
分配方式
Randomized
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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are severe or moderate ARDS
  • Patients who have signed ICF

排除标准

  • Patients who are younger than 18 years old or older than 75 years old
  • Patients whose vital signs are unstable
  • Patients who are in other clinical trails
  • Patients who are pregnant

结局指标

主要结局

oxygenation (improvement of oxygenation)

时间窗: improvement of oxygenation 3 minutes after lung recruiment

detection of index 3 minutes after lung recruiment (1) PO2/FiO2\>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1),(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2\<5%

次要结局

未报告次要终点

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianfeng Xie

Director

Southeast University, China

研究点 (1)

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