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

NCT ID: NCT06769308

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard of care sedation

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

Group Type: ACTIVE_COMPARATOR

Sedation titration according to standard of care

Intervention Type: PROCEDURE

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

EEG guided sedation

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

Group Type: EXPERIMENTAL

Sedation titration according to qEEG

Intervention Type: DEVICE

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

Interventions

Sedation titration according to qEEG

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

Intervention Type: DEVICE

Sedation titration according to standard of care

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcispedale S. Anna, Ferrara

UNKNOWN

Sponsor Role: collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Scaramuzzo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Sant'Anna

Ferrara, Italy, Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Federico II - "Policlinico"

Napoli, Napoli, Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Gaetano Scaramuzzo, MD

Role: CONTACT

scrgtn@unife.it

0532239158

Facility Contacts

Gaetano Scaramuzzo, MD

Role: primary

scrgtn@unife.it

Annachiara Marra, MD, PhD

Role: primary

dottmarraannachiara@gmail.com

800 184 715

Annachiara Marra, MD, PhD

Role: backup

Other Identifiers

SED_ICU

Identifier Type: -

Identifier Source: org_study_id