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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversità degli Studi di Ferrara

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sedation titration according to qEEG

    Device

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

  • Sedation titration according to standard of care

    Procedure/Surgery

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

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Standard of care sedationActive comparator 1 intervention
Group B: EEG guided sedationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ventilator free days

The number of days without ventilation

Time frame
Day 28

Secondary outcomes

1

Delirium occurrence

Occurrence of delirium

Time frame
Daily after extubation
2

ICU lenght of stay

Lenght of stay in the intensive care unit

Time frame
ICU discharge
3

Drug consumption

Evaluation of sedative drug consumption during ICU stay

Time frame
ICU discharge

Other outcomes

Sponsors and contacts

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