Comparing Closed-Loop Versus Conventional Synchronization in Breathing Support for Children in Intensive Care A Randomized Crossover Study

What this Trial Is About

Researchers are studying children aged 1 month to 18 years who are receiving mechanical ventilation due to acute respiratory failure or pediatric respiratory distress syndrome. The study aims to compare the safety and effectiveness of a closed-loop synchronization controller with conventional manual synchronization during invasive mechanical ventilation of spontaneous breathing pediatric patients in a pediatric intensive care unit PICU. The trial involves two treatment periods, each lasting one hour. In one period, the pressure support of the childs spontaneous breathing will be automatically adjusted by the closed-loop synchronization controller using analysis of pressure and flow waveforms. In the other period, the pressure support will be manually set using conventional synchronization settings. This is a randomized crossover study where participants receive both interventions. During the study, researchers will monitor and measure the asynchrony index, major and minor asynchronies, comfort behavioral score, air leak, oxygen saturation SpO2, and end-tidal carbon dioxide EtCO2 during each one-hour treatment period. The trial involves close observation and evaluation of how well the synchronization methods support the childs breathing while minimizing asynchrony and discomfort.

Closed-loop Synchronization Versus Conventional Synchronization