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

Recruiting now · Not applicable

Conditions studied: Sedation Complication, Mechanical Ventilation Complication

In brief

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.

Key facts

Study ID: NCT06769308
Run by: Università degli Studi di Ferrara
People needed: 174
Starts: 2024-01-01
Expected to finish: 2027-07-31
Last updated by the study team: 2025-01-10

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for >48 hours Ongoing sedation

You may not qualify if…

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 is running

Azienda Ospedaliera Universitaria Sant'Anna — Ferrara, Italy, Italy (enrolling)
Azienda Ospedaliera Universitaria Federico II - "Policlinico" — Naples, Napoli, Italy

Full record on ClinicalTrials.gov

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