Validation of a Processed EEG Device for Monitoring Sedation in PICU

Recruiting now

Conditions studied: Sedation Complication

In brief

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.

Key facts

Study ID

NCT05969483

Run by

Azienda Ospedaliera di Padova

People needed

150

Starts

2022-10-01

Expected to finish

2025-03-01

Last updated by the study team

2025-01-28

Who can join

Age: 0 and older, up to 18. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• sedated and ventilated patients admitted in PICU

You may not qualify if…

• skin lesions
• significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.

Where it is running

• University Hospital of Padova — Padova, Italy (enrolling)

Full record on ClinicalTrials.gov

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