Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients underwent cardiorespiratory support | Device | Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glacia G Basso | Contact | +55(17)2136-7005 | glaucia.basso@braile.com.br | |
| Priscila C Joao | Contact | +55(17)2136-7005 | priscila.joao@braile.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Vitor S Barzila | Hospital BrasÃlia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital BrasÃlia | Recruiting | Lago Sul | BrasÃlia - DF | 71681-603 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |