Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19): A Randomized Controlled Trial Evaluating Respiratory Mechanics-Based Ventilation Strategies

What this Trial Is About

Researchers are evaluating the best way to set mechanical ventilators for patients with acute respiratory distress syndrome (ARDS), including those with COVID-19 and non-COVID-19 ARDS. This multicenter randomized controlled trial uses an adaptive design to compare ventilation strategies based on respiratory mechanics, aiming to reduce mortality 60 days after treatment begins. ARDS causes severe lung inflammation that makes ventilation challenging and can lead to ventilator-induced lung injury (VILI). The trial includes two groups: one receiving standard ventilation care following existing guidelines, and the other receiving individualized ventilation settings based on bedside measurements of lung recruitability and breathing effort. The experimental group undergoes specific maneuvers to assess airway closure and recruitability to set ventilator parameters such as tidal volume and positive end-expiratory pressure (PEEP). Both groups receive volume control ventilation, with adjustments made as patients begin spontaneous breathing. Participants will be closely monitored during their ICU stay, with assessments including duration of ventilation, ICU and hospital stay length, organ dysfunction, barotrauma, and mortality at several time points up to 60 days. The main outcome measured is all-cause mortality at 60 days. Data collection, analysis, and patient management follow a shared protocol across both COVID-19 and non-COVID-19 patient groups, with safety and effectiveness monitored throughout the study period.

Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)