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临床试验/NCT02361398
NCT02361398已完成不适用

Individualized Positive End Expiratory Pressure(PEEP) Setting by EIT in Patients With Acute Respiratory Distress Syndrome(ARDS)

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2018年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
survival

研究概览

简要总结

The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS).

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<300 and PEEP >5cmH2O
  • •Body mass index < =40
  • •Written inform consent

排除标准

  • •pregnant,intracranial hypertension
  • •left ventricular dysfunction (EF<25% )
  • •Patients with end-stage conditions(death expected within 90 days)

研究组 & 干预措施

control group

No Intervention

If patients are assigned to the control group, the Individualized PEEP Setting was by PEEP-FiO2 table based on ARDS-net protocol.

EIT group

Experimental

the Individualized PEEP titration by EIT was administered to the patients in the EIT group.

干预措施: the EIT guide the individualized PEEP Setting (Other)

结局指标

主要结局

survival

时间窗: 28-day

Non-survive and survive

Arterial oxygenation

时间窗: 72h

PaO2(mmHg) measured by blood gas analysis

次要结局

  • length of ICU stay and mechanical ventilated day(28days)
  • pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days;(7days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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