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Recruiting NCT05969483
Validation of a Processed EEG Device for Monitoring Sedation in PICU
Trial Parameters
Condition Sedation Complication
Sponsor Azienda Ospedaliera di Padova
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 1 Day
Max Age 18 Years
Start Date 2022-10-01
Completion 2025-02
Interventions
pEEG monitoring
Brief Summary
The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement between pEEG score and Comfort Behavioural Scale (CBS) (goal standard). Participants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each other.
Eligibility Criteria
Inclusion Criteria: \- sedated and ventilated patients admitted in PICU Exclusion Criteria: * skin lesions * significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.