Clinical trial NCT05693051: Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
Extracorporeal Membrane Oxygenation
COVID-19 Acute Respiratory Distress Syndrome
Prone Position
Adverse Event
Keywords: ARDS
VV-ECMO
Prone position ventilation
Adverse Events
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-01-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: Inclusion Criteria: patients with COVID-19 induced severe ARDS accepted for and treated with VV-ECMO in Denmark

-

Exclusion Criteria:

* none

Primary outcomes:
measure: 90 day mortality
timeFrame: 90 days
Secondary outcomes:
measure: Time-to-wean
timeFrame: From start of ECMO treatment to succesful weaning from ECMO
measure: Recruitment Response to prone position ventilation
timeFrame: from prone position start to prone position end
measure: Oxygenation Response to prone position ventilation
timeFrame: from prone position start to prone position end
Other outcomes:
measure: Adverse Events
timeFrame: From ECMO start to ECMO end (all causes)
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, CardioThoracic Intensive care Unit
city: Copenhagen
country: Denmark
facility: University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care
Study officials:
affiliation: Department of CardioThoracic Anesthesia and Intensive Care, Rigshospitalet University Hospital
name: Vibeke L Jorgensen, M.D
role: PRINCIPAL_INVESTIGATOR
References: