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

Università degli Studi di Ferrara

Status: Enrolling

Conditions: Mechanical Ventilation Complication; Sedation Complication

Treatments: Procedure: Sedation titration according to standard of care; Device: Sedation titration according to qEEG

Study type: Interventional

Funder types: Other

Identifiers

NCT06769308

SED_ICU

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Standard of care sedation

Active Comparator group

Description:

The patients will be sedated according to the current standard of care (Behavioral pain scale and Richmond Agitation-Sedation Scale).

Treatment:

Procedure: Sedation titration according to standard of care

EEG guided sedation

Experimental group

Description:

The patients will be sedated according to the EEG derived indexes (qCON/qNOX).

Treatment:

Device: Sedation titration according to qEEG