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OpenTrials
Completed

NCT Number: NCT05693051

Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO

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

Completed

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, CardioThoracic Intensive care Unit, Aarhus, Denmark

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About this study

Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous Extracorporeal membrane oxygenation (VV-ECMO).

Methods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March 2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of patients treated with PPV, number of PPV-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with COVID-19 induced severe ARDS accepted for and treated with VV-ECMO in Denmark

-

Exclusion criteria

  • none

Treatment and study plan

Prone Position Ventilation

Other

Turning the patient prone for 16 hours

Primary outcomes

  1. 90 day mortality

    Time frame: 90 days

    all cause mortality 90 days after ECMO start

Secondary outcomes

  1. Time-to-wean

    Time frame: From start of ECMO treatment to succesful weaning from ECMO

    Time from ECMO start to succesful weaning from ECMO

  2. Recruitment Response to prone position ventilation

    Time frame: from prone position start to prone position end

    lung recruitment

  3. Oxygenation Response to prone position ventilation

    Time frame: from prone position start to prone position end

    Oxygenation

Other outcomes

  1. Adverse Events

    Time frame: From ECMO start to ECMO end (all causes)

    Number and nature of adverse events related to prone position ventilation

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Use of Prone Position Ventilation (PPV) in Danish Patients With COVID-19 Induced Severe Adult Respiratory Distress Syndrome (ARDS) Treated With Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2023
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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