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

NCT06769308 | Recruiting

• 1 other identifier: SED_ICU
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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.

Conditions

Sedation Complication; Mechanical Ventilation Complication

Keywords

ICU, sedation, analgesia, mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilator free days

  The number of days without ventilation

  Day 28

Secondary Outcomes (3)

• Delirium occurrence

  Daily after extubation

• ICU lenght of stay

  ICU discharge

• Drug consumption

  ICU discharge

Study Arms (2)

Standard of care sedation

ACTIVE COMPARATOR

The patients will be sedated according to the current standard of care (Behavioral pain scale and Richmond Agitation-Sedation Scale).

Procedure: Sedation titration according to standard of care

EEG guided sedation

EXPERIMENTAL

The patients will be sedated according to the EEG derived indexes (qCON/qNOX).

Device: Sedation titration according to qEEG

Interventions

Sedation titration according to qEEG DEVICE

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

EEG guided sedation

Sedation titration according to standard of care PROCEDURE

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

Standard of care sedation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Arcispedale S. Anna, Ferrara: collaborator

Study Sites (2)

Azienda Ospedaliera Universitaria Sant'Anna

Ferrara, Italy, 44100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II - "Policlinico"

Napoli, Napoli, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gaetano Scaramuzzo, MD

CONTACT

0532239158; scrgtn@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)