Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sedation titration according to qEEG, Sedation titration according to standard of care.
- Who it may be relevant to
- Registry conditions: Sedation Complication, Mechanical Ventilation Complication. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial
Overview
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.
Interventions
- Device Sedation titration according to qEEG
Sedation will be titrated according to the EEG derived indexes (qCON/qNOX) - Procedure Sedation titration according to standard of care
Sedation will be provided according to the standard of care of the unit (clinical scales)
Primary outcome measures
- Ventilator free days [Time frame: Day 28]
Secondary outcome measures (3)
- Delirium occurrence [Time frame: Daily after extubation]
- ICU lenght of stay [Time frame: ICU discharge]
- Drug consumption [Time frame: ICU discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Italy · 2 centers
- Azienda Ospedaliera Universitaria Sant'Anna — Ferrara
- Azienda Ospedaliera Universitaria Federico II - "Policlinico" — Naples
Identifiers
NCT: NCT06769308 · SED_ICU