Mechanical Ventilation Complication, Sedation Complication
Conditions
Keywords
ICU, sedation, analgesia, mechanical ventilation
Brief 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.
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)
Sponsors
Arcispedale S. Anna, Ferrara
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free days | Day 28 | The number of days without ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delirium occurrence | Daily after extubation | Occurrence of delirium |
| ICU lenght of stay | ICU discharge | Lenght of stay in the intensive care unit |
| Drug consumption | ICU discharge | Evaluation of sedative drug consumption during ICU stay |
Countries
Italy
Contacts
Primary ContactGaetano Scaramuzzo, MD
Outcome results
None listed