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Clinical Trials/NCT05780255
NCT05780255
Completed
Not Applicable

Quality of Life 1y and 2 y After VV-ECMO for COVID-19, Measured by the 36-item Short Form Health Survey

University Hospital, Ghent1 site in 1 country28 target enrollmentApril 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Acute Respiratory Distress Syndrome
Sponsor
University Hospital, Ghent
Enrollment
28
Locations
1
Primary Endpoint
Quality of life 1y after ECMO insertion
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Detailed Description

The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health. The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.

Registry
clinicaltrials.gov
Start Date
April 20, 2021
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with PCR-confirmed COVID-19 infection AND
  • Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of life 1y after ECMO insertion

Time Frame: 1 year

Result of SF-36 1 year after VV-ECMO insertion

Quality of life 2y after ECMO insertion

Time Frame: 2 years

Result of SF-36 2 years after VV-ECMO insertion

in-hospital mortality

Time Frame: mortality during hospitalisation, up to two years

Secondary Outcomes

  • Duration of mechanical ventilation(2 years)
  • death after hospital discharge(after discharge from the hospital upon 2 years after)
  • LOS ICU(from the day of intensive care unit admission until the day of transfer to the ward, up to two years)
  • Lung complications requiring surgical treatment(From the start of VV-ECMO support until weaning of VV-ECMO, up to two years)
  • LOS hospital(from the day of hospital admission until the day that the participant is transferred to home, up to two years)
  • Incidence of acute kidney injury(from the day of hospital admission until the day that the participant is transferred to home, up to two years)

Study Sites (1)

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