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Validation of a Processed EEG Device for Monitoring Sedation in PICU

NCT05969483 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-01-28

No results posted yet for this 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.

Conditions

  • Sedation Complication

Interventions

DEVICE

pEEG monitoring

pEEG monitoring during PICU admission

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • angela amigoni, MD · University Hospital of Padova

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-02-28
Completion
2025-03-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969483 on ClinicalTrials.gov