RecruitingNCT05969483

Validation of a Processed EEG Device for Monitoring Sedation in PICU

Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children


Sponsor

Azienda Ospedaliera di Padova

Enrollment

150 participants

Start Date

Oct 1, 2022

Study Type

OBSERVATIONAL

Conditions

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: FEMALEMin Age: 1 DayMax Age: 18 Years

Inclusion Criteria1

  • \- sedated and ventilated patients admitted in PICU

Exclusion Criteria2

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEpEEG monitoring

pEEG monitoring during PICU admission


Locations(1)

University Hospital of Padova

Padova, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05969483


Related Trials