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Chilling discovery: hypothermia may skew brain monitors during bypass

NCT ID NCT07508579

Knowledge-focused Sponsor: Sakarya University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This observational study looks at how lowering body temperature during heart-lung bypass surgery affects two common brain monitors (BIS and PSI). Researchers will track 60 adults undergoing planned coronary bypass surgery. The goal is to see if the monitors' readings change differently when the body is cooled, which could help doctors better gauge anesthesia depth.

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 study could help doctors better interpret brain activity monitors during heart surgeries involving cooling.
What could go wrong
This is a small observational study, not testing a treatment. Results may not apply to all patients or surgeries.

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 60 people

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

Started

May 2026

Expected to finish

Dec 2026

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

Adult patients undergoing elective on-pump coronary artery bypass grafting (CABG) with cardiopulmonary bypass at a single tertiary care center will be included. All participants will receive standard general anesthesia and perioperative management according to institutional protocols. Patients will be monitored intraoperatively with both Bispectral Index (BIS) and Patient State Index (PSI) devices, and data will be collected at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass.

Ages

18 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: * Age ≥18 years * Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery * Planned use of general anesthesia * Written informed consent Exclusion Criteria: * Preexisting neurological disease * Use of medications affecting Electroencephalography (e.g., antiepileptics) * Severe hepatic dysfunction * Emergency surgery * Inadequate signal quality for anesthesia depth monitoring

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Hypothermia

As listed by the trial registrant

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

Cardiopulmonary bypass Depth of anesthesia monitoring Hypothermia; anesthesia

Contacts and locations

Locations

  • Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation

    Sakarya, Serdivan, Turkey (Türkiye)

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