Actively Recruiting
Validation of a Processed EEG Device for Monitoring Sedation in PICU
Led by Azienda Ospedaliera di Padova · Updated on 2025-01-28
150
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Validation of a Processed EEG Device for Monitoring Sedation in PICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sedated and ventilated patients admitted in PICU
You will not qualify if you...
- Skin lesions
- Significant traumatic lesions in the area where the Masimo Sedline�� sensor needs to be applied
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Padova
Padova, Italy, 35128
Actively Recruiting
Research Team
A
angela amigoni, MD
CONTACT
A
anna tessari
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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