Helmet Noninvasive Ventilation vs Continuous Positive Airway Pressure vs High-flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure Treatment An Open-label Multicentre Randomized Trial

What this Trial Is About

Researchers are evaluating the best initial treatment for patients with acute moderate-to-severe hypoxemic respiratory failure. This study compares three methods of respiratory support: helmet noninvasive ventilation (NIV), helmet continuous positive airway pressure (CPAP), and high-flow nasal oxygen. The goal is to see which method reduces the need for endotracheal intubation in intensive care patients. The trial is open-label and randomized, involving multiple centers. Participants will be assigned to one of three groups. The helmet NIV group will receive continuous helmet pressure support ventilation for at least 16 hours per day during the first two days, with specific ventilator settings. The helmet CPAP group will receive continuous helmet CPAP for at least 16 hours per day, delivered through a high-flow generator with set air flow and pressure levels. The high-flow nasal oxygen group will receive flows starting at 50-60 liters per minute, with adjustments based on comfort and patient needs, and weaning considered only after 48 hours. During the study, researchers will monitor participants closely in the ICU, recording the rate of intubation over 28 days as the primary outcome. Secondary outcomes include days free from invasive mechanical ventilation at 28, 60, and 90 days, mortality rates in the ICU and hospital, ICU and hospital free days at 90 days, and the incidence of pneumonia, shock, and barotrauma. The total participation time varies, with follow-up assessments extending up to 90 days.

Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure