Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure. As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established. The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
In both arms, the treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge. Patients will have to undergo the allocated treatment within 1 hour from the moment of randomization and within 24 hours from admission in the intensive care unit
Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
Bologna, Italy
SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
Chieti, Italy
Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
Ferrara, Italy
Infermi Hospital
Rimini, Italy
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
Respiratory-support free days within 28 days from randomization
The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)
Time frame: 28 days
Endotracheal intubation
The proportion of patients requiring endotracheal intubation in the two groups. The need for endotracheal intubation will be established with predefined criteria, which will be evaluated a posteriori by an independent adjudication committee
Time frame: 28 days
Invasive ventilation-free days within 28 days from randomization
The number of days in which patients did not receive invasive mechanical ventilation
Time frame: 28 days
Invasive ventilation-free days within 60 days from randomization
The number of days in which patients did not receive invasive mechanical ventilation
Time frame: 60 days
Oxygenation
The ratio of PaO2 to FiO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time frame: 28 days
Carbon dioxide
PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time frame: 28 days
Dyspnea
Dyspnea will be evaluated through a visual analog scale (0-10, where 10 represents the most sever symptom) will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time frame: 28 days
Respiratory rate
Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge
Time frame: 28 days
In-intensive care unit mortality
Clinical outcome (dead/alive) at intensive care unit discharge
Time frame: 90 days
In-hospital mortality
Clinical outcome (dead/alive) at hospital discharge
Time frame: 90 days
90-day mortality
Clinical outcome (dead/alive) at 90 days after randomization
Time frame: 90 days
Quality of life after recovery
Quality of life in survivors, assessed by Short Form-36 questionnaire
Time frame: 1 year
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