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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04031794
Enrollment
250
Registered
2019-07-24
Start date
2019-07-22
Completion date
2025-07-31
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Hypoxemia, Severe Acute Respiratory Distress Syndrome

Keywords

Veno-venous ECMO, Severe ARDS, Refractory Hypoxemia

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.

Interventions

DEVICEExtra Corporeal Membrane Oxygenator (ECMO)

Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital outcomeat least 90 daysPatient survive until discharge

Secondary

MeasureTime frameDescription
28 days mortality28 daysPatient who dead before 28 days

Countries

Thailand

Contacts

Primary ContactSurat Tongyoo, Dr.
surat.ton@mahidol.ac.th0820137771
Backup ContactChairat Permpikul, Dr.
chairat.per@mahidol.ac.th

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026