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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication; Sedation Complication
• Intervention / Treatment: Procedure: Sedation titration according to standard of care; Device: Sedation titration according to qEEG

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaetano Scaramuzzo, MD; Phone Number: 0532239158; Email: scrgtn@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44100
    • Recruiting
    • Azienda Ospedaliera Universitaria Sant'Anna
    • Contact: Gaetano Scaramuzzo, MD; Email: scrgtn@unife.it
  • Napoli, Italy
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Federico II - "Policlinico"
    • Contact: Annachiara Marra, MD, PhD; Phone Number: 800 184 715; Email: dottmarraannachiara@gmail.com
    • Contact: Annachiara Marra, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care sedation; 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; Sedation will be provided according to the standard of care of the unit (clinical scales)
Experimental: EEG guided sedation; The patients will be sedated according to the EEG derived indexes (qCON/qNOX).	Device: Sedation titration according to qEEG; Sedation will be titrated according to the EEG derived indexes (qCON/qNOX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator free days	The number of days without ventilation	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium occurrence	Occurrence of delirium	Daily after extubation
ICU lenght of stay	Lenght of stay in the intensive care unit	ICU discharge
Drug consumption	Evaluation of sedative drug consumption during ICU stay	ICU discharge

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: Arcispedale S. Anna, Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ICU, sedation, analgesia, mechanical ventilation
• Other Study ID Numbers: SED_ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No