Multicenter, open label, three-arm randomized trial to assess the effect of helmet noninvasive ventilation vs. helmet continuous positive airway pressure vs. high-flow nasal oxygen on the rate of endotracheal intubation of patients with acute moderate-to-severe hypoxemic respiratory failure
The optimal initial management of acute hypoxemic respiratory failure is uncertain. Helmet noninvasive ventilation and high-flow nasal oxygen appear as the most promising techniques in this setting. Recently, the first head-to-head randomized trial compared first-line continuous treatment with helmet pressure support ventilation with specific settings (PEEP=12 cmH2O pressure and pressure support=10-12 cmH2O) vs. high-flow nasal oxygen alone in patients with moderate-to-severe hypoxemic respiratory failure. Results showed no significant inter-group difference in the days free of respiratory support at 28 days, but lower intubation rate and increased 28-day invasive ventilation-free days in the helmet group. Use of helmet noninvasive ventilation is less frequent than use of helmet continuous positive airway pressure, which is simpler to use. The investigators designed an open-label, multicentre randomized trial to assess the effect of helmet pressure support ventilation and continuous airway pressure as compared to high-flow nasal oxygen on the intubation rate of patients with moderate-to-severe hypoxemic respiratory failure in the intensive care unit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Treatment of acute hypoxemic respiratory failure
Gemelli
Rome, Italy
RECRUITINGRate of Endotracheal intubation
The proportion of patients requiring endotracheal intubation according to predefined criteria
Time frame: 28 days
Days free of invasive mechanical ventilation at day 28
The number of days in which patients do not receive mechanical ventilation within 28 days from randomization
Time frame: 28 days
Days free of invasive mechanical ventilation at day 60
The number of days in which patients do not receive mechanical ventilation within 60 days from randomization
Time frame: 60 days
Days free of invasive mechanical ventilation at day 90
The number of days in which patients do not receive mechanical ventilation within 60 days from randomization
Time frame: 90 days
Rate of In-intensive care unit mortality
All-cause mortality, assessed at the discharge from the intensive care unit
Time frame: 90 days
Rate of In-hospital care unit mortality
All-cause mortality, assessed at the discharge from the hospital
Time frame: 90 days
Rate of 90-day mortality
All-cause 90-day mortality
Time frame: 90 days
90-day ICU free days
The days not spent in the intensive care unit by the patient on a 90-day basis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 90 days
90-day hospital free days
The days not spent in the hospital by the patient on a 90-day basis
Time frame: 90 days
Incidence of pneumonia
Incidence of pneumonia, diagnosed after the treatment start and during the ICU stay
Time frame: 90 days
Incidence of shock
Incidence of shock, diagnosed after treatment start and during the ICU stay
Time frame: 90 days
Incidence of barotrauma
Incidence of barotrauma, defined as pneumothorax o pneumomediastinum after treatment start and during the ICU stay
Time frame: 90 days