Study flow chart
Procedures and assessments | Inclusion and randomisation | Follow-up and data collection | End of study | ||
H1,H6, H12–H24–48 | ICU stay | Day 28 | ICU discharge and day 90 | ||
Screening inclusion/non-inclusion criteria | X | X | X | ||
Information and consent | X | ||||
Treatment allocation | X | ||||
Clinical characteristics | |||||
Demographic data, comorbidity, reason for respiratory failure* | X | X | |||
Clinical data | X | X | X | ||
Chest X-ray | X | ||||
SOFA score, SAPS II, McCabe score | X | SOFA (daily during the 2 days after intubation) | SOFA (daily during the 2 days after intubation) | ||
Evaluation of oxygenation therapy | |||||
Arterial blood gas and FiO2 estimation2 | X | X | |||
VAS for respiratory discomfort | X | X | |||
Dyspnoea score, pattern of breathing | X | ||||
Duration of oxygen strategies | X | X | X | X | |
Use of alternative oxygen therapy | X | X | X | X | |
Criteria of intubation and description of intubation procedure | X | X | X | X | |
Outcomes and complications | |||||
Outcomes (death, intubation, ventilation-free day at 28 days, ICU and hospital length of stay) Complications during ICU stay | X | X (phone contact) | X (phone contact) |
*Reasons for respiratory failure will be collected in the electronic case-report form and classified as follows: pneumonia (community-acquired pneumonia, hospital-acquired pneumonia and documentation if available), other common risks (non-pulmonary sepsis, aspiration of gastric content, major trauma, pulmonary contusion, inhalation injury, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions or transfusion-associated acute lung injury, pancreatitis, drowning), other non-common risks (connective tissue disease, small-vessel vasculitis, hypersensitivity pneumonitis, drug-induced pneumonia, haematology malignancy, solid tumour, lymphangitic carcinomatosis, organising pneumonia, diffuse alveolar haemorrhage, massive haemoptysis, no aetiology identified, other).
FiO2, fractional inspired oxygen; ICU, intensive care unit; SAPS II, Simplified Acute Physiology Score II; SOFA, Sequential-related Organ Failure Assessment; VAS, visual analogue scale.