Japanese Esophageal Pressure Sub-study of EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome (EXTEND ARDS-J EP Study)

What this Trial Is About

Researchers are studying adult patients with acute respiratory distress syndrome (ARDS) who require mechanical ventilation to better understand how to predict success or failure during breathing trials and after extubation. This observational Japanese sub-study of the EXTEND ARDS trial focuses on measuring esophageal pressure (Pes) to directly assess inspiratory effort, aiming to improve the timing and outcomes of ventilator weaning in ARDS patients. Current weaning guidelines are based mostly on general respiratory failure studies, so this research fills an important gap by focusing specifically on ARDS. The study measures esophageal pressure using Nutrivent balloons inserted into the lower third of the esophagus, with placement confirmed by cardiac signals and chest X-ray. Measurements are taken during spontaneous breathing trials (SBT) and after extubation, calculating the difference between end-expiratory and peak inspiratory pressures (\u0394Pes). The study evaluates whether these measurements can predict failure of SBT or extubation within 48 hours, helping to guide clinical decisions. Participants are adult ARDS patients who are expected to be on invasive mechanical ventilation for more than 48 hours. The study involves monitoring esophageal pressure with specialized equipment while patients undergo standard weaning procedures. Researchers will track reintubation rates within 48 hours post-extubation and SBT failures up to 120 minutes from the start of the trial. This prospective observational study collects physiological data without altering usual care, aiming to improve prediction of extubation outcomes and patient safety.

EXTEND ARDS-J Esophageal Pressure Study