NCT06769308

Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs. The present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.

Conditions

• Sedation Complication
• Mechanical Ventilation Complication

Interventions

Type	Name	Description
DEVICE	Sedation titration according to qEEG	Sedation will be titrated according to the EEG derived indexes (qCON/qNOX)
PROCEDURE	Sedation titration according to standard of care	Sedation will be provided according to the standard of care of the unit (clinical scales)

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2027-07-31
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

2 sites across 1 country: Italy