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Validation of a Processed EEG Device for Monitoring Sedation in PICU

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Dec 2024 to Feb 2025
    • Study completion date: Jun 2025 to Mar 2025
    v3
  2. Primary completion date: Mar 2024 to Dec 2024
    • Study completion date: Sep 2024 to Jun 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05969483
Lead Sponsor Azienda Ospedaliera di Padova
Conditions
(from sponsor)		 Sedation Complication
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov