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Brain-Safe bypass: smart monitor aims to personalize blood pressure during heart surgery

NCT ID NCT06492746

Knowledge-focused Sponsor: Becton, Dickinson and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 1 time

Summary

This study tests a new monitoring tool called the Cerebral Adaptive Index (CAI) that may help doctors set personalized blood pressure targets during heart surgery. The tool tracks brain blood flow in real time. Researchers will observe 120 adults aged 45 and older who are at high risk for brain blood vessel disease and are having heart surgery with a heart-lung machine. The goal is to see how often the CAI signals potential brain stress during standard care.

What this could mean

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

Active substance
Cerebral Adaptive Index (CAI) monitoring device
What this could lead to
If successful, this could lead to personalized blood pressure management during heart surgery, potentially reducing brain injury risk.
What could go wrong
This is a small pilot study, so results may not be conclusive. The index is new and unproven, and may not improve outcomes.

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

About 120 people

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

Started

Jun 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

45 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: 1. Signed informed consent 2. Age ≥ 45 years 3. Planned cardiac surgery with Cardiopulmonary Bypass (CPB) 4. Planned monitoring with ForeSight sensor and HemoSphere monitor 5. Planned arterial catheterization for blood pressure monitoring 6. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure \> 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease Exclusion Criteria: 1. Non-English speaking 2. Confirmed to be pregnant 3. Surgery for congenital heart defect 4. Non-availability of HemoSphere with laptop CAI interface

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

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

Blood pressure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwestern University Hospital

    RECRUITING

    Evanston, Illinois, 60611, United States

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