Status:
RECRUITING
Personal BP - CAI Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Blood Pressure
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
Eligibility Criteria
Inclusion
- Signed informed consent
- Age ≥ 45 years
- Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
- Planned monitoring with ForeSight sensor and HemoSphere monitor
- Planned arterial catheterization for blood pressure monitoring
- 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
- Non-English speaking
- Confirmed to be pregnant
- Surgery for congenital heart defect
- Non-availability of HemoSphere with laptop CAI interface
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06492746
Start Date
June 3 2024
End Date
December 1 2025
Last Update
July 14 2025
Active Locations (1)
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1
Northwestern University Hospital
Evanston, Illinois, United States, 60611