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

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome; Prone Position; Extracorporeal Membrane Oxygenation; Adverse Event; ARDS, Human

• Registration Number: NCT05693051
• Lead Sponsor: Rigshospitalet, Denmark

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90 day mortality	90 days	all cause mortality 90 days after ECMO start

Secondary Outcome Measures

Name	Time	Method
Oxygenation Response to prone position ventilation	from prone position start to prone position end	Oxygenation
Time-to-wean	From start of ECMO treatment to succesful weaning from ECMO	Time from ECMO start to succesful weaning from ECMO
Recruitment Response to prone position ventilation	from prone position start to prone position end	lung recruitment

Trial Locations

Locations (2)

Aarhus University Hospital, CardioThoracic Intensive care Unit; 🇩🇰 Aarhus, Denmark

University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care; 🇩🇰 Copenhagen, Denmark