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Completed

NCT Number: NCT05780255

Quality of Life 1y and 2 y After VV-ECMO for COVID-19

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.

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Death Extracorporeal Membrane Oxygenation Complication Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Quality of Life RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent university hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

vv-ECMO

Device

veno-venous extracorporeal membrane oxygenation

Primary outcomes

  1. in-hospital mortality

    Time frame: mortality during hospitalisation, up to two years

  2. Quality of life 1y after ECMO insertion

    Time frame: 1 year

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

  3. Quality of life 2y after ECMO insertion

    Time frame: 2 years

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

Secondary outcomes

  1. Lung complications requiring surgical treatment

    Time frame: From the start of VV-ECMO support until weaning of VV-ECMO, up to two years

    Hemothorax or lung abcedation

  2. Duration of mechanical ventilation

    Time frame: 2 years

  3. LOS ICU

    Time frame: from the day of intensive care unit admission until the day of transfer to the ward, up to two years

    length of stay at the intensive care unit

  4. LOS hospital

    Time frame: from the day of hospital admission until the day that the participant is transferred to home, up to two years

    length of stay at the hospital

  5. death after hospital discharge

    Time frame: after discharge from the hospital upon 2 years after

    all-cause death

  6. Incidence of acute kidney injury

    Time frame: from the day of hospital admission until the day that the participant is transferred to home, up to two years

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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