NCT06492746RecruitingNot Applicable
Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
Becton, Dickinson and Company2 sites in 1 country120 target enrollmentStarted: June 3, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- To determine the magnitude and duration of CAI
Study Overview
Brief Summary
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Non-English speaking
- •Confirmed to be pregnant
- •Surgery for congenital heart defect
- •Non-availability of HemoSphere with laptop CAI interface
Arms & Interventions
Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring
Experimental
Intervention: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring (Device)
Outcomes
Primary Outcomes
To determine the magnitude and duration of CAI
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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