Using EEG to guide sedation and pain relief in ICU patients
Official title: Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial
Run by Università degli Studi di Ferrara · NCT06769308 · Data updated 2026-11-12
This study tests if using a special device to monitor brain activity can help doctors give the right amount of sedation and pain relief to ICU patients on ventilators, aiming to improve their recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Università degli Studi di Ferrara Academic / other |
| Locations | 2 sites (Ferrara, Italy and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | January 10, 2025 |
| Trial ID | NCT06769308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-90 who are admitted to the ICU for more than 48 hours of mechanical ventilation and are currently receiving sedation.
✕Probably not a fit
Patients who are expected to be on mechanical ventilation for less than 48 hours or have conditions that prevent electrode placement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the use of the Conox® system, which analyzes EEG data to guide sedation and analgesia in ICU patients requiring mechanical ventilation. The goal is to optimize sedation levels to reduce complications associated with excessive sedation, such as prolonged mechanical ventilation and increased risk of infections. Patients will be monitored using this device to ensure their sedation is tailored to their specific needs, compared to standard care practices. The study aims to improve patient outcomes in critical care settings.
Why it matters
Potential benefit: If successful, this approach could lead to shorter ICU stays and reduced complications for patients on mechanical ventilation.
How similar studies have gone: Other studies have shown promise in using EEG monitoring for sedation management, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for \>48 hours Ongoing sedation Exclusion Criteria: Mechanical ventilation (MV) for less than 48 hours Patient or next of kin refusal to participate BMI \> 35 Cerebrovascular disease Scheduled surgery Neuromuscular disease Presence of craniofacial trauma that prevents the placement of electrodes
Where it's running
-
Azienda Ospedaliera Universitaria Sant'Anna
Ferrara, Italy, Italy Recruiting -
Azienda Ospedaliera Universitaria Federico II - "Policlinico"
Naples, Napoli, Italy Not yet recruiting
Study contacts
- Study coordinator: Gaetano Scaramuzzo, MD
- Email: scrgtn@unife.it
- Phone: 0532239158
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.