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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Death; Extracorporeal Membrane Oxygenation Complication; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: VV-ECMO

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with PCR-confirmed COVID-19 infection with ARDS who require veno-venous ECMO therapy.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 positive patients; Patients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO	Device: VV-ECMO; veno-venous extracorporeal membrane oxygenation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation		2 years
Lung complications requiring surgical treatment	Hemothorax or lung abcedation	From the start of VV-ECMO support until weaning of VV-ECMO, up to two years
LOS ICU	length of stay at the intensive care unit	from the day of intensive care unit admission until the day of transfer to the ward, up to two years
LOS hospital	length of stay at the hospital	from the day of hospital admission until the day that the participant is transferred to home, up to two years
death after hospital discharge	all-cause death	after discharge from the hospital upon 2 years after
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Harlinde Peperstraete, UZ Gent

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; COVID-19; ECMO
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: COVID-19-ECMO BC-09806

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