A Pragmatic Pilot Trial Evaluating Inspiratory Pressure Adjustment Based on Pressure Muscle Index in Patients Undergoing Pressure Support Ventilation

What this Trial Is About

Researchers are exploring two strategies for setting pressure support levels in patients receiving pressure support ventilation (PSV) in intensive care units. The study focuses on adults with acute hypoxic respiratory failure who need mechanical ventilation. It aims to compare the traditional method based on tidal volume (VT) and respiratory rate (RR) with a newer method using the pressure muscle index (PMI), which may better reflect patient inspiratory effort. This pilot trial will examine clinical outcomes and how well clinicians adhere to these strategies to guide future larger studies. The trial involves two treatment periods at two centers using a sequential cluster crossover design. The first 4-week period uses the VT/RR-targeted pressure support settings, followed by a 4-week washout, then a 4-week PMI-targeted period. In the VT/RR group, pressure support is adjusted to keep VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths per minute. In the PMI group, pressure support is adjusted to keep PMI between 0 and 2 cmH2O. Both groups receive standard mechanical ventilation care, including sedation and analgesia management, with adjustments made twice daily during PSV. Participants will be monitored daily until weaning, death, discharge, or 28 days after randomization. Data collected include ventilator settings, respiratory and hemodynamic parameters, sedation and analgesia levels, and clinical outcomes such as duration of mechanical ventilation and mortality. The study also includes clinician surveys about the acceptability and feasibility of the PMI-based strategy. This comprehensive approach will help assess the practicality of PMI-targeted pressure support in critical care settings.

A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial