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Brain wave alert: new tool could predict delirium hours before it strikes after heart surgery

NCT ID NCT07686900

Knowledge-focused Sponsor: Southeast University, China Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

After heart surgery, up to half of patients may experience a sudden state of confusion called delirium, which can slow recovery. This study aims to build a computer-based early warning system that combines real-time brain wave (EEG), brain oxygen, and heart function measurements to predict delirium 1 to 6 hours before it starts. Researchers will enroll 200 adults aged 18 to 80 in the ICU after heart surgery, continuously recording their vital signals and regularly checking their mental state. The goal is to give doctors a window to intervene early, potentially improving recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this early warning system could help doctors prevent delirium after heart surgery, leading to faster recovery and shorter ICU stays.
What could go wrong
This is an observational study to develop a prediction tool, not a treatment test. The system may not prove accurate enough for real-world use, and it does not test any intervention to prevent delirium.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult patients after cardiac surgery admitted to the Department of Critical Care Medicine, Zhongda Hospital, Southeast University, from May 1, 2026 to December 30, 2027.

Ages

15 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients (18-80 years) admitted to the Department of Critical Care Medicine. 2. Underwent cardiac surgery. 3. Under multimodal monitoring (including EEG, cerebral oximetry, and invasive arterial blood pressure). 4. Signed informed consent. Exclusion Criteria: 1. Pre-existing dementia, history of psychiatric disorders, or long-term use of antipsychotic medications, preventing accurate assessment of delirium. 2. Preoperative severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR \<30 mL/min/1.73 m²). 3. Severe craniocerebral injury, intracranial space-occupying lesion, or history of epilepsy. 4. Inability to obtain continuous EEG or cerebral oximetry signals due to technical reasons (e.g., scalp injury, abnormal probe placement site). 5. Patients expected to die within 24 hours. 6. Patients deemed unsuitable for the study by the investigator.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgical procedures Postoperative delirium

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Zhongda hospital Southeast University

    Nanjing, Jiangsu, China

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