Study period | ||||||
---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | |||
Timepoint | 0 | 0 | 2 h | 12 h | 1–28 days maximum | 28 days maximum |
Enrolment | ||||||
Eligibility screen | × | |||||
Informed consent | × | |||||
Allocation | × | |||||
Interventions | ||||||
NIV | × | |||||
HFNC | × | |||||
Assessments | ||||||
Baseline variables | ||||||
Demographics | × | |||||
Medical history | × | |||||
Mechanism of injury | × | |||||
Injury severe score | × | |||||
Chest AIS score | × | |||||
SOFA score | × | |||||
Outcome variables | ||||||
Intubation | × | × | × | |||
Treatment switch | × | × | × | |||
Vital signs | × | × | × | × | ||
Comfort score | × | × | × | × | ||
Dyspnea score | × | × | × | × | ||
Arterial blood gas | × | × | × | × | ||
Number of nursing airway care interventions | × | |||||
Pneumonia or pneumothorax | × | |||||
Skin breakdown | × | |||||
Causes of treatment failure | × | |||||
NIV/HFNC duration | × | |||||
Hospital length of stay | × | |||||
ICU length of stay | × | |||||
28-day mortality | × |