Phase 3 Study Comparing Personalized Lung-Stress Ventilation to Standard Mechanical Ventilation in Adults with Acute Respiratory Distress Syndrome

What this Trial Is About

This research aims to compare two ventilation strategies in patients with Acute Respiratory Distress Syndrome ARDS, a serious lung condition with high mortality despite recent advances. The study evaluates whether a personalized lung-stress oriented ventilation approach can improve survival compared to standard mechanical ventilation. This is a phase III, multi-center, randomized controlled trial designed to assess outcomes such as mortality, lung injury, and hemodynamic safety. Participants will receive one of two ventilation methods the precision ventilation strategy, which adjusts ventilator settings based on driving pressure and esophageal manometry to keep lung stress within a normal range, or guided usual care, where ventilator settings follow standard best-practice guidelines with some protocol limits. The precision strategy involves careful titration of tidal volume, positive end-expiratory pressure PEEP, and oxygen levels to reduce lung injury, while the usual care arm allows clinicians to manage ventilation within established targets. During the study, participants will be monitored for 60 days to measure mortality and other outcomes such as ventilator-free days, respiratory support-free days, and incidence of barotrauma. Researchers will collect clinical data on lung injury and hemodynamic stability, including shock-free days through Day 14. The trial includes randomization, and participants will be followed closely through the course of their ventilation treatment and recovery period. The total duration of involvement varies depending on clinical course and survival.

Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome