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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05693051
Other study ID # 20049299-PPV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date November 1, 2022

Study information

Verified date March 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: patients with COVID-19 induced severe ARDS accepted for and treated with VV-ECMO in Denmark - Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prone position ventilation
Turning the patient prone for 16 hours

Locations

Country Name City State
Denmark Aarhus University Hospital, CardioThoracic Intensive care Unit Aarhus
Denmark University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse Events Number and nature of adverse events related to prone position ventilation From ECMO start to ECMO end (all causes)
Primary 90 day mortality all cause mortality 90 days after ECMO start 90 days
Secondary Time-to-wean Time from ECMO start to succesful weaning from ECMO From start of ECMO treatment to succesful weaning from ECMO
Secondary Recruitment Response to prone position ventilation lung recruitment from prone position start to prone position end
Secondary Oxygenation Response to prone position ventilation Oxygenation from prone position start to prone position end
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