ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The effectiveness of the set in ensuring adequate flow to the patient
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients without a diagnosis of COVID-19
结局指标
主要结局
The effectiveness of the set in ensuring adequate flow to the patient
时间窗: 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
The effectiveness of the oxygenator in ensuring adequate gas exchange
时间窗: 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)
次要结局
- Adverse events during extracorporeal membrane oxygenation use(during the use of extracorporeal membrane oxygenation)
- Rate free of membrane dysfunction(during the use of extracorporeal membrane oxygenation)
- Decannulation rate(during the use of extracorporeal membrane oxygenation)
- Mortality rate during ECMO use(during the use of extracorporeal membrane oxygenation)
- Duration of ECMO system usage(during the use of extracorporeal membrane oxygenation)
- Need for oxygenator due to dysfunction(during the use of extracorporeal membrane oxygenation)