Using EEG to guide sedation and pain relief in ICU patients
Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Università degli Studi di Ferrara Academic / other |
| Locations | 2 sites (Ferrara, Italy and 1 other locations) |
| Trial ID | NCT06769308 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using EEG monitoring for sedation management, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Ferrara, Italy and 1 other locations
- 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
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.