ECMO Braile Biomédica® in COVID-19 Patients

COVID-19 Clinical Trial

— ECMO_COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086405
• Other study ID #: ECMO COVID
• Status: Recruiting
• Start date: September 14, 2023
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: Braile Biomedica Ind. Com. e Repr. Ltda.
• Contact: Glacia G Basso
• Phone: +55(17)2136-7005
• Email: glaucia.basso[@]braile.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Patients underwent cardiorespiratory support
Patients underwent cardiorespiratory support using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator

Locations

Country	Name	City	State
Brazil	Hospital Brasília	Lago Sul	Brasília - DF

Sponsors (1)

Lead Sponsor	Collaborator
Braile Biomedica Ind. Com. e Repr. Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

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