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

Not Applicable

Recruiting

• Conditions: Sedation Complication; Mechanical Ventilation Complication

• Registration Number: NCT06769308
• Lead Sponsor: Università degli Studi di Ferrara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-12-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilator free days	Day 28	The number of days without ventilation

Secondary Outcome Measures

Name	Time	Method
Delirium occurrence	Daily after extubation	Occurrence of delirium
ICU lenght of stay	ICU discharge	Lenght of stay in the intensive care unit
Drug consumption	ICU discharge	Evaluation of sedative drug consumption during ICU stay

Trial Locations

Locations (2)

Azienda Ospedaliera Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy

Azienda Ospedaliera Universitaria Federico II - "Policlinico"; 🇮🇹 Napoli, Italy