Study of Esophageal Pressure-Guided Lung Optimization with Positive End-Expiratory Pressure in Adults with Obesity on Mechanical Ventilation

What this Trial Is About

Researchers are evaluating the use of esophageal pressure-guided positive end-expiratory pressure PEEP titration in patients with respiratory failure who have a body mass index BMI of 30 kgm2 or higher and require mechanical ventilation. This randomized controlled feasibility study aims to determine if a larger definitive trial is practical and to compare the effects of this specialized PEEP titration method against standard care on respiratory mechanics and clinical outcomes. The trial is conducted in a hospital setting and focuses on patients with obesity undergoing invasive ventilation. Participants will be randomly assigned to one of two groups one receiving esophageal pressure-guided PEEP titration, where an esophageal balloon catheter is placed within 4 hours after randomization to guide PEEP adjustments targeting an end-expiratory transpulmonary pressure of 0-2 cmH2O with higher targets allowed for severe hypoxemia, and the other receiving standard care PEEP management without esophageal monitoring. The esophageal catheter is repositioned and PEEP reassessed twice daily and removed before extubation or after 28 days. Standard care follows institutional guidelines, including ARDSNet tables for ARDS patients. During the study, participants will have continuous monitoring of respiratory parameters, including PEEP levels, driving pressures, oxygenation ratios, days free of mechanical ventilation, ICU-free days, and mortality up to hospital discharge or 30 days. The primary outcome is the feasibility of conducting a larger trial over 14 months. Safety limits on pressures and hemodynamic stability will be monitored. The total study duration includes assessments in the first 7 days and follow-up until hospital discharge or 30 days after enrollment.

Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients