Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06769308

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

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 pain relief are key in caring for critically ill patients who need mechanical ventilation. Excessive sedation can prolong ventilation time and ICU stay, and increase risks like low blood pressure, blood clots, and hospital-acquired pneumonia. This research evaluates the use of the Conox4 system in ICU patients to better monitor sedation levels using EEG signals, aiming to improve sedation management compared to standard clinical methods. Participants will be randomly assigned to two groups: one where sedation is adjusted using EEG-based indexes (qCON/qNOX) from the Conox device, and another where sedation follows the usual clinical scales and standard care. This trial compares these two approaches in patients expected to need mechanical ventilation for more than 48 hours. Throughout their ICU stay, patients will be closely monitored with EEG or standard clinical assessments to guide sedation. Researchers will track ventilator-free days by day 28 to evaluate outcomes. The study includes adults aged 18 to 90 who have been in the ICU less than 24 hours and are already sedated. Safety and effectiveness of sedation management will be observed during their treatment period.

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

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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

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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