Clinical Trial

Validation of a Processed EEG Device for Monitoring Sedation in PICU

Recruiting
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Record status
This record was last updated January 28, 2025 (before its estimated February 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-23; most recent amendment 2025-01-27.
Trial Details
NCT Number NCT05969483
Lead Sponsor Azienda Ospedaliera di Padova
Conditions Sedation Complication
Enrollment 150 participants
Start Date 2022-10-01
Primary Completion 2025-02 (estimated)
Study Completion 2025-03 (estimated)
Updated on ClinicalTrials.gov 2025-01-28