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Clinical Trials in Italy / NCT05969483
Recruiting Observational

Validation of a Processed EEG Device for Monitoring Sedation in PICU

NCT05969483 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliera di Padova
Phase
Observational
Started
2022-10-01
Last updated
2025-01-28

Condition(s) studied

Sedation Complication

Investigational drug(s) / intervention(s)

pEEG monitoring

pEEG monitoring: pEEG monitoring during PICU admission

Study 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

Sex
FEMALE
Min age
1 Day
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Padova Padova Italy Recruiting

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Other trials for the same condition

Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05969483 on ClinicalTrials.gov ↗ ← All trials in Italy