ECMO Braile Biomédica® in COVID-19 Patients (ECMO_COVID)

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Patients underwent cardiorespiratory support

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Glacia G Basso; Phone Number: +55(17)2136-7005; Email: glaucia.basso@braile.com.br
• Study Contact Backup: Name: Priscila C Joao; Phone Number: +55(17)2136-7005; Email: priscila.joao@braile.com.br

Study Locations

• Brazil
  • Brasília - DF
    • Lago Sul, Brasília - DF, Brazil, 71681-603
      • Recruiting
      • Hospital Brasilia
      • Contact: Vitor S Barzilai; Phone Number: 8209 +55 (61) 3305 8208; Email: vitorbarzilai@ictdf.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
• Investigators: Principal Investigator: Vitor S Barzila, Hospital Brasilia

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; ECMO; Membrane Oxygenator
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ECMO COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No