Blood Pressure
Conditions
Brief summary
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
Interventions
DEVICEHemoSphere 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.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTCristina Johnson
Outcome results
None listed