Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children

What this Trial Is About

Researchers are evaluating the use of a processed EEG device called Masimo Sedline® to monitor the level of sedation in critically ill children who are mechanically ventilated. This observational study aims to compare the agreement between the Sedline® processed EEG score, known as the Patient State Index (PSI), and the Comfort Behavioural Scale (CBS), which is the standard tool used to assess sedation. The goal is to determine if the Sedline® device can be a reliable additional or main monitoring tool, especially for patients who are chemically paralyzed. During the study, all sedated and mechanically ventilated children admitted to the pediatric intensive care unit (PICU) will have the Sedline® sensor applied. The pEEG scores, including PSI, will be recorded every 4 hours for up to 5 days by the primary nurse. At the same time, sedation levels will be assessed using the CBS by two independent clinicians, a specialized PICU nurse and a critical-care physician, who will not know each other's assessments. For patients receiving neuromuscular blocking agents, sedation will be evaluated during planned "paralysis holidays" when muscle activity returns. Participants will be closely monitored with regular sedation assessments and EEG readings during their PICU stay. Researchers will analyze the agreement between the Sedline® PSI and CBS scores at 4 and 8 hours after ventilation begins, including in different patient subgroups such as neonates and those with seizures. Data on sedation adequacy and muscle activity will be collected to better understand the tool's reliability. The study involves no changes to sedation protocols, which remain at the treating physician's discretion. Participation duration varies with length of ventilation but monitoring occurs mainly during the first 5 days.

Validation of a Processed EEG Device for Monitoring Sedation in PICU