About this trial
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
PaCO2 ≤ 45 mmHg;
Disqualifiers
Acute asthma or COPD exacerbation,
Cardiac failure or fluid overload as primary cause of respiratory failure;
Unstable angina or ongoing acute myocardial infarction;
Acute respiratory acidosis with pH < 7.35 and PaCO2 > 45 mmHg;
Trial design
Parallel
Treatments tested in this trial
high flow nasal cannula
Devicehumidified and heated oxygen
standard oxygen
Other interventionoxygen delivery through Venturi mask
Treatment groups
Trial outcomes
Primary outcomes
Early deterioration
occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.
Secondary outcomes
Development of respiratory acidosis
arterial pH
Development of hypercapnia
arterial pCO2
Worsening hypoxemia
P/F ratio
Worsening respiratory distress
respiratory frequency
Locations
Sponsors and contacts
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