The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure
Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated acute hypoxemic respiratory failure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
High Flow Oxygen nasal cannula
In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
RECRUITINGPaO2/FiO2 improvement
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
Time frame: at baseline and at 21 hours
Intensive Care admission
Rate of admission to Intensive Care Unit in the two arms
Time frame: 30 days
Sensation of device comfort and dyspnoea
Evaluation of subjective sensation of device comfort and dyspnoea in the two arms
Time frame: Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours
Time to downgrade to conventional oxygen therapy
Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula
Time frame: 30 days
In-hospital mortality
Mortality rate in the 2 arms
Time frame: 30 days
New hospital admission
Rate of a new hospital admission within 30 days
Time frame: 30 days
PaO2/FiO2 improvement
Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 45 hours compared to baseline PaO2/FiO2
Time frame: at baseline and at 45 hours
PaO2/FiO2 improvement
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Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 30 hours compared to baseline PaO2/FiO2
Time frame: at baseline and at 30 days