Examination/assessment | Treatment | Follow-up | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Screening | Visit 0 | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5a | Visit 6a | ||||||||
Timepoint | 0 h | 1 h ± 30 min | 2 h ± 30 min | 4 h ± 30 min | 6 h ± 30 min | 12 h ± 60 min | 24 h ± 60 min | 36 h ± 90 min | 48 h ± 120 min | 72 h ± 180 min | discharge | day 7b ± 1 day | day 28 | day 90 | |
Informed consent | Xc | Xd | |||||||||||||
Inclusion criteria/exclusion criteria | X | ||||||||||||||
Randomization | X | ||||||||||||||
Patient characteristics (anamnesis, comorbidity) | X | ||||||||||||||
Medication | X | Xe | Xe | Xe | X | ||||||||||
Clinical parameters (heart rate, respiratory rate, blood pressure, Borg’s scale) | X | X | X | X | X | X | X | X | X | X | X | X | |||
Adverse events/side-effects | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Glasgow coma scale (GCS) | X | X | X | X | X | X | X | X | X | X | X | ||||
Blood gas analysis (BGA): pO2, pCO2, pH, SpO2, FIO2 | X | X | X | X | X | X | X | X | X | X | X | X | |||
Therapy according to allocated device: device parameters | X | X6 | X | X | X | X | X | X | X | X | X | Xg | Xf | Xf | |
Therapy: oxygen supplement | X | X | X | X | X | X | X | X | X | X | X | Xf | Xf | Xf | |
infection parameters and biomarkers (optional) | X | Xe | Xe |