The primary object of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS (ARDS caused by Non-COVID-19 or COVID-19).
Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present
Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on chest X-ray or CT scan
Patients with PaO2/ FiO2 ratio ≤ 300 mmHg (PEEP ≥ 5 cmH2O)
Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
Patients who are treated with ECMO or HFOV
Patients with renal dialysis therapy for chronic renal failure
Patients with congestive heart failure (NYHA class IV)
Parallel
NOA-001
DeviceNOA-001 will be replaced regularly (at 22 to 24 hours after the initiation of procedure), and will be continuously performed until 168 hours from the enrollment.
Ventilator Free Days (VFD, Days alive and ventilator-free)
VFD is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFD) within 28 days.
All-cause Mortality
Fatalities, mortality all-causes
Mortality in ICU
All-cause mortality for patients who died in Intensive Care Units.
Mortality in Hospital
The number of patients who died in hospital
Changes in PaO2/ FiO2 ratio
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