Multiparameter Monitoring System for Sedation in Critically Ill ICU Patients (ROMANTIC)

What this Trial Is About

Researchers are investigating a new multiparameter monitoring system called ROMANTIC to improve sedation management in critically ill patients in intensive care units (ICUs). Sedation dosing is crucial to avoid complications like delirium, prolonged ventilation, and increased mortality. Current sedation monitoring methods, such as clinical scales (RASS/SAS), have limitations especially when patients are unresponsive or using neuromuscular blockers. ROMANTIC aims to use machine learning with various patient data—including demographic, pharmacological, hemodynamic, respiratory, and EEG information—to better classify sedation status into underdosing, appropriate dosing, or overdosing categories. The study has two phases: first, a prospective observational cohort study collecting comprehensive data from ICU patients receiving sedation and mechanical ventilation for over 24 hours. Data include vital signs, sedation drugs (Fentanyl with Propofol or Midazolam), EEG signals, and clinical sedation scales recorded hourly. Two or three data collection windows occur per patient, starting after intubation, during sedation suspension, and if needed, during re-sedation. The second phase uses this data to develop and test a machine learning model that informs ICU staff about patients' sedation depth. Participants will be monitored through detailed clinical and laboratory assessments during their ICU stay, including sedation scales, EEG, hemodynamics, respiratory parameters, pain scores, neuromuscular blockade tests, and blood samples for drug concentrations. Delirium will be assessed twice daily after awakening. The primary outcome is time to extubation after sedation suspension, with secondary outcomes including length of ICU stay, duration of mechanical ventilation, incidence of ICU delirium, and serum sedative levels. The study's goal is to create a tool that helps non-specialized staff determine sedation levels more accurately and efficiently, potentially improving patient outcomes and ICU resource use.

multipaRameter mOnitoring systeM for sedAtion iNThe ICu