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Completed
NCT05969483
Validation of a Processed EEG Device for Monitoring Sedation in PICU
Conditions: Sedation Complication
Sex: Female
Ages: 1 Day – 18 Years
Healthy volunteers: No
Enrollment: 150
Sponsor: Azienda Ospedaliera di Padova
Location: University Hospital of Padova Padova Italy
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 Criteria
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.
Source: ClinicalTrials.gov (NCT05969483). StuddyBuddy aggregates publicly available trial information.
