ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Severe Acute Respiratory Distress Syndrome, Refractory Hypoxemia

Intervention / Treatment
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* Device: Extra Corporeal Membrane Oxygenator (ECMO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Terminally ill patient Patient who sign for do not resuscitation Metastatic malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional ARDS treatment group<br>Patients who they or their 1st degree relative refuse to initiate ECMO. They will receive conventional ARDS treatment. | |
| ECMO group<br>Patients who ECMO is initiated for treat refractory hypoxemia. They will receive conventional ARDS treatment and ECMO support | Device: Extra Corporeal Membrane Oxygenator (ECMO)<br>* Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital outcome | Patient survive until discharge | at least 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days mortality | Patient who dead before 28 days | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veno-venous ECMO, Severe ARDS, Refractory Hypoxemia