Sedation titration according to qEEG
DeviceSedation will be titrated according to the EEG derived indexes (qCON/qNOX)
NCT Number: NCT06769308
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Azienda Ospedaliera Universitaria Sant'Anna, Ferrara, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Sedation will be titrated according to the EEG derived indexes (qCON/qNOX)
Sedation will be provided according to the standard of care of the unit (clinical scales)
Time frame: Day 28
The number of days without ventilation
Time frame: Daily after extubation
Occurrence of delirium
Time frame: ICU discharge
Lenght of stay in the intensive care unit
Time frame: ICU discharge
Evaluation of sedative drug consumption during ICU stay
Contact information is provided by the study sponsor or research team.
Università degli Studi di Ferrara
Other
Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial
Acronym: SED_ICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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