Monitoring sedation levels in critically ill children using a processed EEG device
Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children
This study is testing a new device that measures brain activity to see if it can help doctors monitor sedation levels in critically ill children on ventilators in the pediatric intensive care unit.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | Female |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Locations | 1 site (Padova) |
| Trial ID | NCT05969483 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the use of a processed EEG (pEEG) device for monitoring sedation levels in mechanically ventilated children in the pediatric intensive care unit (PICU). Participants will be assessed using both the pEEG scores and the Comfort Behavioral Scale (CBS) to determine the agreement between these two methods. The study will include all consecutive patients admitted to the PICU who are receiving analgosedation, regardless of whether they are receiving neuromuscular blocking agents (NMBAs). The goal is to establish pEEG as a reliable tool for sedation monitoring in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are mechanically ventilated children in the PICU who require analgosedation.
Not a fit: Patients with skin lesions or significant traumatic injuries in the area where the pEEG sensor is applied will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance sedation monitoring in critically ill children, leading to improved patient outcomes and safety.
How similar studies have performed: While the use of pEEG for sedation monitoring is gaining interest, this specific validation approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Padova
- University Hospital of Padova — Padova, Italy (Recruiting)
Study contacts
- Principal investigator: angela amigoni, MD — University Hospital of Padova
- Study coordinator: angela amigoni, MD
- Email: angela.amigoni@aopd.veneto.it
- Phone: +39 339 8333765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.