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

NCT06769308 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-01-10

No results posted yet for this study

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.

Conditions

  • Sedation Complication
  • Mechanical Ventilation Complication

Interventions

DEVICE

Sedation titration according to qEEG

Sedation will be titrated according to the EEG derived indexes (qCON/qNOX)

PROCEDURE

Sedation titration according to standard of care

Sedation will be provided according to the standard of care of the unit (clinical scales)

Sponsors & Collaborators

  • Arcispedale S. Anna, Ferrara

    collaborator UNKNOWN

  • Università degli Studi di Ferrara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769308 on ClinicalTrials.gov