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

Edwards Lifesciences1 site in 1 country120 target enrollmentJune 3, 2024

ConditionsBlood Pressure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Blood Pressure
Sponsor: Edwards Lifesciences
Enrollment: 120
Locations: 1
Primary Endpoint: To determine the magnitude and duration of CAI
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 3, 2024

End Date

December 1, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

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

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.