Sedation ComplicationSED_ICUNCT06769308
Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients
A study testing Sedation titration according to qEEG in people with Sedation Complication and Mechanical Ventilation Complication, run by Università degli Studi di Ferrara at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sedation Complication, Mechanical Ventilation Complication
- What is being tested?
- Sedation titration according to qEEG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for >48 hours Ongoing sedation
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Sant'Anna
Ferrara, Italy, 44100
Gaetano Scaramuzzo, MD, scrgtn@unife.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II - "Policlinico"
Naples, Napoli
Annachiara Marra, MD, PhD, 800 184 715, dottmarraannachiara@gmail.com
Annachiara Marra, MD, PhD
About this study
Official title: 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.
- Being tested
- Sedation titration according to qEEG, Sedation titration according to standard of care
- Keywords
- ICU, sedation, analgesia, mechanical ventilation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation titration according to qEEGDevice
Sedation will be titrated according to the EEG derived indexes (qCON/qNOX)
Sedation titration according to standard of careProcedure or surgery
Sedation will be provided according to the standard of care of the unit (clinical scales)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Sedation titration according to qEEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
The number of days without ventilation
Measured: Day 28
Secondary outcomes (3)
Delirium occurrence
Occurrence of delirium
Measured: Daily after extubation
ICU lenght of stay
Lenght of stay in the intensive care unit
Measured: ICU discharge
Drug consumption
Evaluation of sedative drug consumption during ICU stay
Measured: ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- S. Anna Hospital
- Responsible party
- Principal investigator, Gaetano Scaramuzzo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769308
- Sponsor's protocol ID
- SED_ICU
- Acronym
- SED_ICU
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06769308
- Acronym / sponsor ID
- SED_ICU / SED_ICU
- Keywords
- ICU, sedation, analgesia, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- S. Anna Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care sedation | Active comparator | Procedure: Sedation titration according to standard of careThe patients will be sedated according to the current standard of care (Behavioral pain scale and Richmond Agitation-Sedation Scale). |
| EEG guided sedation | Experimental | Device: Sedation titration according to qEEGThe patients will be sedated according to the EEG derived indexes (qCON/qNOX). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for >48 hours Ongoing sedation
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation titration according to qEEGSedation will be titrated according to the EEG derived indexes (qCON/qNOX) | Device | EEG guided sedation |
| Sedation titration according to standard of careSedation will be provided according to the standard of care of the unit (clinical scales) | Procedure or surgery | Standard of care sedation |
Primary outcome
Ventilator free days
Time frame: Day 28
The number of days without ventilation
3 secondary outcomes
Delirium occurrence
Time frame: Daily after extubation
ICU lenght of stay
Time frame: ICU discharge
Drug consumption
Time frame: ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation titration according to qEEG in people with Sedation Complication and Mechanical Ventilation Complication, run by Università degli Studi di Ferrara at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Scaramuzzo, MD (0532239158, scrgtn@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator free days (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.