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

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication; Quality of Life; COVID-19 Acute Respiratory Distress Syndrome; Death
• Interventions: Device: VV-ECMO

• Registration Number: NCT05780255
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2023-01-31
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-03-22
• Study Completion: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 positive patients	VV-ECMO	Patients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO

Primary Outcome Measures

Name	Time	Method
Quality of life 1y after ECMO insertion	1 year	Result of SF-36 1 year after VV-ECMO insertion
Quality of life 2y after ECMO insertion	2 years	Result of SF-36 2 years after VV-ECMO insertion
in-hospital mortality	mortality during hospitalisation, up to two years

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	2 years
death after hospital discharge	after discharge from the hospital upon 2 years after	all-cause death
LOS ICU	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
Lung complications requiring surgical treatment	From the start of VV-ECMO support until weaning of VV-ECMO, up to two years	Hemothorax or lung abcedation
LOS hospital	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
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

Trial Locations

Locations (1)

Ghent university hospital; 🇧🇪 Ghent, Belgium