Validation of a Processed EEG Device for Monitoring Sedation in PICU
ConditionSedation Complication
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age1-18
SponsorAzienda Ospedaliera di Padova
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
skin lesions
significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.
Trial population
Pediatric patients admitted in PICU who undergone sedation and mechanical (invasive and non invasive) ventilation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
pEEG monitoring
DevicepEEG monitoring during PICU admission
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: sedated and ventilated pediatric critical care patients1 intervention
Trial outcomes
Primary outcomes
1
agreement between PSI (exposure) and CBS scale the CBS
grade of agreement (Kappa of Cohen)
Time frame
T1 (after 4 hours of ventilation)2
agreement between PSI (exposure) and CBS scale
grade of agreement (Kappa of Cohen)
Time frame
T1 (after 8 hours of ventilation)Sponsors and contacts
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Source ClinicalTrials.gov