NCT05693051

Brief Summary

Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

January 18, 2023

Last Update Submit

March 28, 2023

Conditions

ARDS, HumanExtracorporeal Membrane OxygenationCOVID-19 Acute Respiratory Distress SyndromeProne PositionAdverse Event

Keywords

ARDSVV-ECMOProne position ventilationAdverse Events

Outcome Measures

Primary Outcomes (1)

  • 90 day mortality

    all cause mortality 90 days after ECMO start

    90 days

Secondary Outcomes (3)

  • Time-to-wean

    From start of ECMO treatment to succesful weaning from ECMO

  • Recruitment Response to prone position ventilation

    from prone position start to prone position end

  • Oxygenation Response to prone position ventilation

    from prone position start to prone position end

Other Outcomes (1)

  • Adverse Events

    From ECMO start to ECMO end (all causes)

Interventions

Prone position ventilationOTHER

Turning the patient prone for 16 hours

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a nationwide retrospective cohort study of a cohort of 68 patients with PCR confirmed SARS-Cov-2 ARDS, treated with V-V ECMO in the two VV-ECMO centers in Denmark: Aarhus University Hospital in west Denmark and University Hospital Rigshospitalet in Copenhagen, East Denmark. Patients were admitted in the period from 17. March 2020 to 31. December 2021.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital, CardioThoracic Intensive care Unit

Aarhus, 8200, Denmark

Location

University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Vibeke L Jorgensen, M.D

    Department of CardioThoracic Anesthesia and Intensive Care, Rigshospitalet University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, PhD, principal investigator

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 20, 2023

Study Start

October 1, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)