An Adaptive Randomized Controlled Trial Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in ICU Patients with Hypoxemic Acute Respiratory Failure

What this Trial Is About

Researchers are evaluating whether one of two oxygen support methods, noninvasive ventilation (NIV) or high-flow nasal oxygen (HFNO), is better than standard oxygen therapy in reducing death rates by day 28 in patients with hypoxemic acute respiratory failure (ARF). This study is a randomized controlled trial conducted across multiple centers, comparing these oxygenation strategies in intensive care unit patients with ARF. Patients include both medical and surgical cases, with further subgroups based on immune system status and surgery type. Participants are randomly assigned to one of three groups: standard oxygen therapy via a Venturi mask, HFNO delivered through a humidification system or ICU ventilator, or NIV using pressure support and positive end-expiratory pressure through a face mask combined with HFNO between NIV sessions. Oxygen levels are adjusted to maintain adequate blood oxygen saturation, with allowances made for certain medical conditions. The trial uses an adaptive design with parallel groups and stratified randomization. During the study, participants will be monitored for up to 90 days, with primary focus on mortality at 28 days. Additional outcomes include rates of intubation at days 3, 7, and 28, oxygenation status, need for rescue oxygen therapy, length of stay in the ICU and hospital, and adverse events. Data collection will include clinical assessments and oxygen delivery monitoring. The study began in May 2023 and is sponsored by the University Hospital of Montpellier.

Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF