Quality of Life 1y and 2 y After VV-ECMO for COVID-19 | NCT05780255

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

NCT05780255

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Apr 25, 2024Actual

Enrollment

28Actual

Phase

Not provided

Conditions

COVID-19 Acute Respiratory Distress Syndrome
Extracorporeal Membrane Oxygenation Complication
Quality of Life
Death

Interventions

VV-ECMO

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2021Actual

Primary Completion Date

Jan 31, 2023Actual

Completion Date

Feb 1, 2024Actual

First Submitted Date

Mar 13, 2023

First Submission Date that Met QC Criteria

Mar 21, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2024

Last Update Posted Date

Apr 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 positive patients		Patients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO	Device: VV-ECMO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VV-ECMO	Device	veno-venous extracorporeal membrane oxygenation	COVID-19 positive patients

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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
Duration of mechanical ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harlinde Peperstraete	UZ Gent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent university hospital		Ghent		9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death
D000086382	COVID-19

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011024	Pneumonia, Viral
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided