NCT04031794

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Severe Acute Respiratory Distress Syndrome
• Refractory Hypoxemia

Interventions

Type	Name	Description
DEVICE	Extra Corporeal Membrane Oxygenator (ECMO)	Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.

Timeline

• Start date: 2019-07-22
• Primary completion: 2025-07-30
• Completion: 2025-07-31
• First posted: 2019-07-24
• Last updated: 2022-09-21

Locations

1 site across 1 country: Thailand