ECMO Braile Biomédica® in COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System

Conditions
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COVID-19

Intervention / Treatment
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* Device: Patients underwent cardiorespiratory support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Patients underwent cardiorespiratory support|Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of the oxygenator in ensuring adequate gas exchange | 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) | during the first week of use | 
| The effectiveness of the set in ensuring adequate flow to the patient | Nominal flow calculated according to weight or body surface area (50 to 80 mL/Kg or 2.4 L/min of body surface area | during the use of extracorporeal membrane oxygenation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate free of membrane dysfunction | percentage of oxygenators free from dysfunction | during the use of extracorporeal membrane oxygenation | 
| Need for oxygenator due to dysfunction | percentage of oxygenators that needed to be replaced due to dysfunction | during the use of extracorporeal membrane oxygenation | 
| Decannulation rate | percentage of patients who were decannulated from ECMO | during the use of extracorporeal membrane oxygenation | 
| Mortality rate during ECMO use | percentage of patients who progressed to mortality during ECMO use | during the use of extracorporeal membrane oxygenation | 
| Duration of ECMO system usage | Total duration of ECMO use (in days) | during the use of extracorporeal membrane oxygenation | 
| Adverse events during extracorporeal membrane oxygenation use | percentage of adverse events related to the oxygenator | during the use of extracorporeal membrane oxygenation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, COVID-19, Membrane Oxygenator