Validation of a Processed EEG Device for Monitoring Sedation in PICU
Launched by AZIENDA OSPEDALIERA DI PADOVA · Jul 23, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a special device called a processed EEG (pEEG) that helps doctors monitor how sedated children are in the Pediatric Intensive Care Unit (PICU). The researchers want to find out how well the pEEG score matches with another method called the Comfort Behavioral Scale (CBS), which is a standard way to assess how comfortable and sedated a child is. The trial is focused on critically ill children who are on a ventilator, whether or not they are receiving medications that relax their muscles.
To be eligible for this study, children aged 1 to 17 who are sedated and on a ventilator in the PICU can participate. However, if a child has skin issues or significant injuries where the sensor needs to be placed, they won't be able to join. Participants will be monitored using the pEEG device, and their comfort levels will be assessed by trained nurses and doctors who don't know each other's evaluations. This study is currently recruiting participants, and it aims to improve how healthcare providers manage sedation for critically ill children.
Gender
FEMALE
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.
About Azienda Ospedaliera Di Padova
Azienda Ospedaliera di Padova is a prominent healthcare institution located in Padua, Italy, renowned for its commitment to advanced medical research and clinical excellence. As a clinical trial sponsor, it plays a pivotal role in the development and evaluation of innovative therapeutic interventions, contributing to the advancement of medical science and patient care. The organization is dedicated to fostering collaboration among multidisciplinary teams and leveraging cutting-edge technology to facilitate rigorous clinical trials that adhere to the highest ethical and scientific standards. With a strong emphasis on patient safety and data integrity, Azienda Ospedaliera di Padova aims to enhance treatment outcomes and improve healthcare practices globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Padova, , Italy
Patients applied
Trial Officials
angela amigoni, MD
Principal Investigator
University Hospital of Padova
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported