Comparing Closed-Loop and Conventional Synchronization in Adults Using Noninvasive Ventilation A Randomized Cross-over Study in Patients with Respiratory Failure

What this Trial Is About

Researchers are conducting a multicenter, randomized cross-over study to evaluate how well patients tolerate a new device feature called IntelliSync compared to traditional settings during noninvasive ventilation. The study focuses on adults with acute or chronic respiratory failure who are spontaneously breathing and receiving noninvasive ventilation. The goal is to compare patient ventilator asynchrony PVA using automated versus manual synchronization methods to better understand their differences and relationships. Participants will experience two different 30-minute periods of ventilation one where the pressure support is automatically adjusted based on real-time waveform analysis using the IntelliSync software, and another where synchronization is manually set by the clinician. IntelliSync continuously analyzes breathing signals to detect patient efforts and trigger breaths more precisely. The study compares these two methods to assess synchronization quality during noninvasive ventilation. During the study, patients will be monitored closely while researchers collect and analyze hourly and 30-minute recordings of patient ventilator asynchrony. Various statistical tests will be used to evaluate the data, including measures of asynchrony indices and dyspnea scales. Participants will be observed during their ICU or emergency care stay while receiving routine treatment, and all findings will be reported by the research team. The total participation involves a short intervention period with detailed waveform analysis and data collection.

Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients