Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 4:47 PM
Study NCT ID:
NCT04031794
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Extracorporeal Membrane Oxygenator (ECMO) for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: