ECMO Braile Biomédica® in COVID-19 Patients

Recruiting

• Conditions: COVID-19

• Registration Number: NCT06086405
• Lead Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.

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

Study Timeline

• Study Start: 2023-09-14
• Status Verified: 2023-10
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
Adverse events during extracorporeal membrane oxygenation use	during the use of extracorporeal membrane oxygenation	percentage of adverse events related to the oxygenator
Rate free of membrane dysfunction	during the use of extracorporeal membrane oxygenation	percentage of oxygenators free from 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)
Need for oxygenator due to dysfunction	during the use of extracorporeal membrane oxygenation	percentage of oxygenators that needed to be replaced due to dysfunction

Trial Locations

Locations (1)

Hospital Brasília; 🇧🇷 Lago Sul, Brasília - DF, Brazil