Table 1 Data collection flow chart
Timing | Method | Data type and specification |
|---|---|---|
At screening | eCRF (RedCap) | Inclusion and exclusion criteria and informed consent |
At randomisation | eCRF (RedCap) | Allocation, treatment limitations (i.e. ICU admission), weight, height, place of birth, smoking, date of symptom start, gender, clinical frailty scale, mode of respiratory support, SpO2%, litres O2/min, RR/min and NEWS |
One hour post randomisation | CRF paper | SpO2/FiO2-ratio |
24 h post randomisation | CRF paper | Patient comfort (visual analogue scale (VAS) 1–10) |
Daily for 28 days | CRF paper | Mode of respiratory support, number of hours per 24 h in allocated support, nr of hours in prone position per 24 h, NEWS, PEEP or Flow, SpO2%, RR/min and events with commentary (e.g. allocation violation, death, exit from study, ICU admission or hospital discharge) |
Retrospectively from electronic medical charts | eCRF (RedCap) | Comorbidities, vitals, medications, radiology, microbiology and laboratory parameters at triage, randomisation and during hospital stay, and, duration of hospital stay, duration of ICU stay, duration of mechanical ventilation and days alive within 28 and 180 days, respectively. |