Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06769308

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

Led by Università degli Studi di Ferrara · Updated on 2025-01-10

174

Participants Needed

2

Research Sites

186 weeks

Total Duration

On this page

Sponsors

U

Università degli Studi di Ferrara

Lead Sponsor

S

S. Anna Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 90 years
  • Admission to the ICU for less than 24 hours
  • Expected mechanical ventilation for more than 48 hours
  • Ongoing sedation
Not Eligible

You will not qualify if you...

  • Mechanical ventilation for less than 48 hours
  • Patient or next of kin refusal to participate
  • Body mass index (BMI) greater than 35
  • History of cerebrovascular disease
  • Scheduled surgery
  • Presence of neuromuscular disease
  • Craniofacial trauma preventing electrode placement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Azienda Ospedaliera Universitaria Sant'Anna

Ferrara, Italy, Italy, 44100

Actively Recruiting

2

Azienda Ospedaliera Universitaria Federico II - "Policlinico"

Naples, Napoli, Italy

Not Yet Recruiting

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Research Team

G

Gaetano Scaramuzzo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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