Status:
WITHDRAWN
Accelerated Prone Position Ventilation of Patients With COVID-19
Lead Sponsor:
Nordsjaellands Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study i...
Detailed Description
In patients with COVID-19 the incidence of ARDS is 15% and the all-cause mortality 4%. No treatment has been shown to improve the outcome of these patients. Mechanical ventilation in the prone positi...
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age.
- Admitted to an intensive care unit.
- Indication for intubation and mechanical ventilation
- No suspicion of significant cardiac failure induced pulmonary edema.
- Suspected COVID-19 or positive SARS-Cov-2 PCR or equivalent diagnostic test.
- Inclusion as soon as possible and maximum 12 hours after intubation.
Exclusion
- Contraindication for prone position ventilation: Suspected high intracranial pressure, massive hemoptysis requiring an immediate surgical or interventional radiology procedure, tracheal surgery or sternotomy during the previous 15 days, serious facial trauma or facial surgery during the previous 15 days, cardiac pacemaker inserted in the last 2 days, unstable spine, femur, or pelvic fractures, single anterior chest tube with air leaks, body constitution that is incompatible with prone position ventilation (i.e. high BMI)
- Admitted under duress (psychiatry).
- Pregnant or breastfeeding.
- Mechanical ventilation in prone position prior to inclusion in the trial
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04384900
Start Date
May 11 2020
End Date
May 25 2021
Last Update
May 28 2021
Active Locations (1)
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1
Nordsjællands Hospital
Hillerød, Region Hovedstanden, Denmark, 3400