Recruiting

BP

Sponsor:

Becton, Dickinson and Company

Code:

NCT06492746

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

Study Details

Brief summary:

A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets

Conditions

Blood Pressure

Study ID

NCT06492746

Start date

Jun 3, 2024

Status verified date

Jul, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring

Interventions

HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

The arterial line with Acumen IQ sensor and Foresight Elite sensor will be connected to the HemoSphere monitor with laptop displaying the CAI parameter.

Primary outcome measure

  • To determine the magnitude and duration of CAI [ Time Frame: Duration of the procedure through 30 days ]

Central Contacts and Locations

Central contacts

Cristina Johnson

888-713-1564cc_clinical_affairs@edwards.com

Locations

Northwestern University Hospital

Recruiting

Evanston, Illinois, United States, 60611

More Information

Sponsor

Becton, Dickinson and Company

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Becton, Dickinson and Company on 2026-07-08.