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Cooling helmet may shield brain from Post-Surgery mental decline

NCT ID NCT07689500

Disease control Sponsor: Indonesia University 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
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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests whether wearing a cooling helmet during open-heart surgery can reduce the risk of postoperative cognitive dysfunction (POCD)—a decline in memory, attention, and thinking that sometimes follows major surgery. The helmet circulates cold water around the scalp to cool the brain, which may lower its oxygen needs and reduce inflammation. Researchers will compare outcomes in adults who receive the active cooling helmet versus a sham helmet with room-temperature water.

What this could mean

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

Active substance
Cooling helmet (non-invasive head-cooling device with cold water circulation)
What this could lead to
If effective, this cooling helmet could become a simple, low-cost way to protect brain function during open-heart surgery, reducing memory and thinking problems after the procedure.
What could go wrong
This is a single-center trial with 153 participants, so results may not apply broadly. The sham control uses room-temperature water, which may still provide some cooling, and the device may not be comfortable or practical for all patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

153 people

The number who actually took part.

Started

Nov 2025

Finished

Jun 2026

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.

Ages

18 years and older

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: * Scheduled to undergo open heart surgery using cardiopulmonary bypass. * Age older than 18 years. * American Society of Anesthesiologists (ASA) physical status III or IV. * Fully conscious with Glasgow Coma Scale score of 15. * Able to communicate in Indonesian. Exclusion Criteria: * Refusal to participate in the study. * History of central nervous system disorder, such as stroke or intracranial tumor. * History of psychiatric disorder. * Severe cognitive impairment. * Use of psychotropic or narcotic drugs. * Blindness or hearing impairment. * Uncooperative patient.

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Conditions

The condition(s) this trial relates to.

Hypothermia Postoperative Cognitive Complications

As listed by the trial registrant

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

Open heart surgery Postoperative cognitive complications

Contacts and locations

Locations

  • Dr. Cipto Mangunkusumo National Central General Hospital

    Jakarta Pusat, DKI Jakarta, 10430, Indonesia

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