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Clinical Trials/NCT06769308
NCT06769308
Recruiting
Not Applicable

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

Università degli Studi di Ferrara2 sites in 1 country174 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedation Complication
Sponsor
Università degli Studi di Ferrara
Enrollment
174
Locations
2
Primary Endpoint
Ventilator free days
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
July 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università degli Studi di Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Gaetano Scaramuzzo

Principal investigator

Università degli Studi di Ferrara

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

Outcomes

Primary Outcomes

Ventilator free days

Time Frame: Day 28

The number of days without ventilation

Secondary Outcomes

  • Delirium occurrence(Daily after extubation)
  • ICU lenght of stay(ICU discharge)
  • Drug consumption(ICU discharge)

Study Sites (2)

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