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临床试验/NCT04031794
NCT04031794招募中不适用

Extracorporeal Membrane Oxygenator (ECMO) for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure

Mahidol University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Hospital outcome

研究概览

简要总结

Extracorporeal membrane oxygenation (ECMO) had been used to treat refractory hypoxemia associated with acute respiratory distress syndrome (ARDS). There were reported good outcome associated with ECMO for ARDS caused by influenza infection from several ECMO centers. However, the outcome of ECMO support in lower ECMO experience center had not been evaluated. This study aimed to evaluate the outcome of ECMO, comparing with conventional treatment among severe hypoxemic ARDS patients who were admitted in limited ECMO experience hospital.

详细描述

This registry enroll refractory hypoxemia ARDS patients who met the criteria for veno-venous ECMO, according to 2013 Extracorporeal Life Support Organization (ELSO) guideline criteria. The definition of refractory hypoxemia was partial pressure of oxygen:fraction of inspire oxygen (PaO2/FiO2) <100 with fraction of inspire oxygen (FiO2) >90% despite optimal mechanical ventilator support for at least 2 hours.

The ECMO team was alerted for patient evaluation. The patients, who did not consider as ECMO candidate, due to their underlying condition of terminally illness, were excluded.

The decision to initiate ECMO, or not, is dependent on the conference included the patient or the patient first relative, the attending physician and the ECMO team physicians.

Patients who ECMO is initiated will be classified into ECMO group. Patients who they or their 1st degree relative do not agree for ECMO initiation will be treated according to standard treatment for ARDS, and classified in non-ECMO group.

The patients in both groups will be follow up until they are discharged from the hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Diagnosed ARDS according to Berlin criteria
  • Refractory hypoxemia: PaO2/FiO2 <100 with FiO2 >90% despite optimal mechanical ventilator support and paralytic agent infusion
  • Hypoxemia persist for at least 2 hours

排除标准

  • Terminally ill patient
  • Patient who sign for do not resuscitation
  • Metastatic malignancy

结局指标

主要结局

Hospital outcome

时间窗: at least 90 days

Patient survive until discharge

次要结局

  • 28 days mortality(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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