COVID-19
Conditions
Keywords
ECMO, COVID-19, Membrane Oxygenator
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.
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
Interventions
DEVICEPatients underwent cardiorespiratory support
Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator
Sponsors
Braile Biomedica Ind. Com. e Repr. Ltda.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate free of membrane dysfunction | during the use of extracorporeal membrane oxygenation | percentage of oxygenators free from dysfunction |
| Adverse events during extracorporeal membrane oxygenation use | during the use of extracorporeal membrane oxygenation | percentage of adverse events related to the oxygenator |
| Duration of ECMO system usage | during the use of extracorporeal membrane oxygenation | Total duration of ECMO use (in days) |
| Need for oxygenator due to dysfunction | during the use of extracorporeal membrane oxygenation | percentage of oxygenators that needed to be replaced due to dysfunction |
Countries
Brazil
Contacts
Primary ContactGlacia G Basso
Backup ContactPriscila C Joao
Outcome results
None listed