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| Name | Class |
|---|---|
| S. Anna Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care sedation | Active Comparator | The patients will be sedated according to the current standard of care (Behavioral pain scale and Richmond Agitation-Sedation Scale). |
|
| EEG guided sedation | Experimental | The patients will be sedated according to the EEG derived indexes (qCON/qNOX). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation titration according to qEEG | Device | Sedation will be titrated according to the EEG derived indexes (qCON/qNOX) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days | The number of days without ventilation | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium occurrence | Occurrence of delirium | Daily after extubation |
| ICU lenght of stay | Lenght of stay in the intensive care unit | ICU discharge |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaetano Scaramuzzo, MD | Contact | 0532239158 | scrgtn@unife.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Sant'Anna | Recruiting | Ferrara | Italy | 44100 | Italy |
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| Sedation titration according to standard of care | Procedure | Sedation will be provided according to the standard of care of the unit (clinical scales) |
|
| Drug consumption | Evaluation of sedative drug consumption during ICU stay | ICU discharge |
| Azienda Ospedaliera Universitaria Federico II - "Policlinico" | Not yet recruiting | Naples | Napoli | Italy |
|
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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