Table 1

Study flow chart

Procedures and assessmentsInclusion and
randomisation
Follow-up and data collectionEnd of study
H1,H6, H12–H24–48ICU stayDay 28ICU discharge and day 90
Screening inclusion/non-inclusion criteriaXXX
Information and consentX
Treatment allocationX
Clinical characteristics
Demographic data, comorbidity, reason for respiratory failure*XX
Clinical dataXXX
Chest X-rayX
SOFA score, SAPS II, McCabe scoreXSOFA
(daily during the 2 days after intubation)
SOFA
(daily during the 2 days after intubation)
Evaluation of oxygenation therapy
Arterial blood gas and FiO2 estimation2XX
VAS for respiratory discomfortXX
Dyspnoea score, pattern of breathingX
Duration of oxygen strategiesXXXX
Use of alternative oxygen therapyXXXX
Criteria of intubation and description of intubation procedureXXXX
Outcomes and complications
Outcomes (death, intubation, ventilation-free day at 28 days, ICU and hospital length of stay)
Complications during ICU stay
XX (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.