A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation

What this Trial Is About

The trial investigates whether an inspiratory effort-targeted pressure support ventilation (IT-PSV) strategy can improve clinical outcomes compared to the traditional tidal volume and respiratory rate target in adults undergoing pressure support ventilation. This cluster randomized controlled trial focuses on patients with acute hypoxic respiratory failure who have been intubated within seven days and are receiving PSV within 24 hours. The study aims to explore a physiological-oriented ventilation management approach that may impact future mechanical ventilation practices. Participants are randomly assigned to one of two groups: one where pressure support is adjusted to target a pressure muscle index (PMI) between 0 and 2 cmH2O, and another where pressure support is set to achieve a tidal volume between 6 and 8 ml/kg predicted body weight and a respiratory rate between 20 and 35 breaths per minute. Adjustments to pressure support occur at least twice daily during the 24-month intervention period. A four-week training program for ICU staff precedes the trial start. During the study, participants will receive standard mechanical ventilation care including spontaneous breathing trials, weaning, and extubation. Researchers will monitor clinical outcomes such as ventilator-free days within 28 days, duration of mechanical ventilation, time to first spontaneous breathing trial, weaning time, mortality rates, and length of ICU and hospital stays. The study will be conducted in 18 ICUs across several hospitals, with data collected throughout the intervention period.

Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial