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Clinical Trials in the USA / NCT06492746
Recruiting Not applicable

Personal BP - CAI Study

NCT06492746 · tracked via the Priya Life Science USA tracker
Sponsor
Becton, Dickinson and Company
Phase
Not applicable
Started
2024-06-03
Last updated
2026-07-08

Condition(s) studied

Blood Pressure

Investigational drug(s) / intervention(s)

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

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.

Study summary

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

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • To determine the magnitude and duration of CAI — Duration of the procedure through 30 days
    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.

Trial sites (1)

FacilityCityRegionStatus
Northwestern University Hospital Evanston Illinois Recruiting

More Becton, Dickinson and Company trials in the USA

HemoSphere Alta Study Recruiting
The Continuity Study Recruiting

Other trials for the same condition

Non-invasive and Continuous Blood Pressure Monitoring Starting soon
Cocooned Moms Study Recruiting
The Continuity Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06492746 on ClinicalTrials.gov ↗ ← All trials in the USA