RecruitingNot ApplicableNCT06769308

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


Sponsor

Università degli Studi di Ferrara

Enrollment

174 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria1

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

Exclusion Criteria1

  • 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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Interventions

DEVICESedation titration according to qEEG

Sedation will be titrated according to the EEG derived indexes (qCON/qNOX)

PROCEDURESedation titration according to standard of care

Sedation will be provided according to the standard of care of the unit (clinical scales)


Locations(2)

Azienda Ospedaliera Universitaria Sant'Anna

Ferrara, Italy, Italy

Azienda Ospedaliera Universitaria Federico II - "Policlinico"

Naples, Napoli, Italy

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NCT06769308


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