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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05780255
• Other study ID #: COVID-19-ECMO BC-09806
• Status: Completed
• Start date: April 20, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 1, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with PCR-confirmed COVID-19 infection AND

• Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Death
• Extracorporeal Membrane Oxygenation Complication
• Quality of Life
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• VV-ECMO
veno-venous extracorporeal membrane oxygenation

Locations

Country	Name	City	State
Belgium	Ghent university hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality		mortality during hospitalisation, up to two years
Primary	Quality of life 1y after ECMO insertion	Result of SF-36 1 year after VV-ECMO insertion	1 year
Primary	Quality of life 2y after ECMO insertion	Result of SF-36 2 years after VV-ECMO insertion	2 years
Secondary	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
Secondary	Duration of mechanical ventilation		2 years
Secondary	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
Secondary	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
Secondary	death after hospital discharge	all-cause death	after discharge from the hospital upon 2 years after
Secondary	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