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NCT Number: NCT06769308

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria Sant'Anna, Ferrara, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation titration according to qEEG

Device

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

Sedation titration according to standard of care

Procedure

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

Primary outcomes

  1. Ventilator free days

    Time frame: Day 28

    The number of days without ventilation

Secondary outcomes

  1. Delirium occurrence

    Time frame: Daily after extubation

    Occurrence of delirium

  2. ICU lenght of stay

    Time frame: ICU discharge

    Lenght of stay in the intensive care unit

  3. Drug consumption

    Time frame: ICU discharge

    Evaluation of sedative drug consumption during ICU stay

Study contacts

Contact information is provided by the study sponsor or research team.

Gaetano Scaramuzzo, MD

CONTACT

[email protected]

0532239158

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • S. Anna Hospital

Registry information

Official study title

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

Acronym: SED_ICU

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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