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New AI tool aims to prevent dangerous drops in blood pressure during heart surgery

NCT ID NCT05083403

Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a software tool called the Hypotension Prediction Index (HPI) in 170 adults undergoing heart surgery with a heart-lung machine. The tool alerts doctors when a patient's blood pressure is likely to drop dangerously low. The goal was to see if using this tool could shorten the time patients spend with low blood pressure in the operating room and intensive care unit. The trial was terminated early, so its full impact is unknown.

What this could mean

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

Active substance
Acumen HPI software (a prediction tool) used with standard monitoring equipment
What this could lead to
If successful, this tool could help doctors prevent dangerously low blood pressure during and after heart surgery, potentially reducing complications.
What could go wrong
The trial was terminated early, so results are limited. The tool only predicts risk; it does not treat hypotension itself, and its benefit in real-world settings remains unproven.

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

170 people

The number who actually took part.

Started

Mar 2022

Finished

Sep 2025

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

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: 1. Subjects who are at least 18 years of age 2. Subjects who have signed the Informed Consent Form 3. Subjects with planned pressure monitoring with an arterial line 4. Subjects with planned sternotomy 5. Subjects with planned general anesthesia 6. Subjects who have ASA Physical Status ≤ 4 7. Subjects with planned cerebral oximetry monitoring 8. Subjects with planned overnight hospitalization 9. Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery Exclusion Criteria: 1. Subjects with a physical site area too limited for proper Sensor placement 2. Subjects with contraindications for Arterial Line Placement; 3. Subjects participating in another (interventional) study 4. Subjects in whom an intraoperative MAP target will be \< 65 mmHg 5. Subjects with pre-op or pre-pump or post-pump LVEF \< 15% 6. Subjects requiring heart transplant 7. Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass 8. Subjects requiring emergency surgery 9. Subjects with known or identified severe PAH (defined as pulmonary systolic pressure\> 70mmHg or mean pressures \> 55mmHg) as determined by a pre-operative echo or intraoperative Swan-Ganz 10. Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run

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As listed by the trial registrant

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

Cardiopulmonary bypass surgery

Contacts and locations

Locations

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1009, United States

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