ECMO_COVID: ECMO Braile Biomédica® in COVID-19 Patients
Study Details
Study Description
Brief Summary
Retrospective data collection to evaluate the gas transfer capacity of the Braile Biomédica® OxyPrime® ECMO BRCoating® Membrane Oxygenator in COVID-19 patients during the pandemic.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Multicenter, retrospective, non-comparative, non-randomized study to assess the clinical performance of the OxyPrime® ECMO BRCoating® Membrane Oxygenator in adult patients with COVID-19
Study Design
Outcome Measures
Primary Outcome Measures
- The effectiveness of the oxygenator in ensuring adequate gas exchange [during the first week of use]
To ensure adequate oxygenation (post-membrane pO2 > 150 mmHg during the first week of use) and CO2 elimination (post-membrane pCO2 < 40 mmHg or pre-membrane pCO2 - post-membrane pCO2 > 10 mmHg)
- The effectiveness of the set in ensuring adequate flow to the patient [during the use of extracorporeal membrane oxygenation]
Nominal flow calculated according to weight or body surface area (50 to 80 mL/Kg or 2.4 L/min of body surface area
Secondary Outcome Measures
- Rate free of membrane dysfunction [during the use of extracorporeal membrane oxygenation]
percentage of oxygenators free from dysfunction
- Need for oxygenator due to dysfunction [during the use of extracorporeal membrane oxygenation]
percentage of oxygenators that needed to be replaced due to dysfunction
- Decannulation rate [during the use of extracorporeal membrane oxygenation]
percentage of patients who were decannulated from ECMO
- Mortality rate during ECMO use [during the use of extracorporeal membrane oxygenation]
percentage of patients who progressed to mortality during ECMO use
- Duration of ECMO system usage [during the use of extracorporeal membrane oxygenation]
Total duration of ECMO use (in days)
- Adverse events during extracorporeal membrane oxygenation use [during the use of extracorporeal membrane oxygenation]
percentage of adverse events related to the oxygenator
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator, from March 2020 to July 2022, following the Instructions for Use (IFU) of the products.
Exclusion Criteria:
- Patients without a diagnosis of COVID-19
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Brasília | Lago Sul | Brasília - DF | Brazil | 71681-603 |
Sponsors and Collaborators
- Braile Biomedica Ind. Com. e Repr. Ltda.
Investigators
- Principal Investigator: Vitor S Barzila, Hospital Brasília
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECMO COVID