ARDS, Human Clinical Trial
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)
Verified date | March 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aarhus University Hospital |
Denmark,
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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