Personal BP - CAI Study

Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation

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

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Johnson; Phone Number: 888-713-1564; Email: cc_clinical_affairs@edwards.com

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Hospital
      • Contact: Bin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the magnitude and duration of CAI	To determine the sum of the product of magnitude and duration that CAI during cardiopulmonary bypass (CPB) is at or above the threshold of 45 during current standard of care and assess the incidence of CAI ≥45 in the absence of decreased cerebral StO2 or MAP thresholds.	Duration of the procedure through 30 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes