Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

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

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Sant'Anna
RECRUITING
Ferrara
Azienda Ospedaliera Universitaria Federico II - Policlinico
NOT_YET_RECRUITING
Napoli
Contact Information
Primary
Gaetano Scaramuzzo, MD
scrgtn@unife.it
0532239158
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 174
Treatments
Active_comparator: Standard of care sedation
The patients will be sedated according to the current standard of care (Behavioral pain scale and Richmond Agitation-Sedation Scale).
Experimental: EEG guided sedation
The patients will be sedated according to the EEG derived indexes (qCON/qNOX).
Sponsors
Leads: Università degli Studi di Ferrara
Collaborators: Arcispedale S. Anna, Ferrara

This content was sourced from clinicaltrials.gov