Personal BP - CAI Study

Becton, Dickinson and Company120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

120

Conditions

Blood Pressure

Interventions

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

The arterial line with Acumen IQ sensor and Foresight Elite sensor will be connected to the HemoSphere monitor with laptop displaying the CAI parameter.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University Hospital

Evanston, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

To determine the magnitude and duration of CAI

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.

Time frame: Duration of the procedure through 30 days

Central Contacts

Cristina Johnson

CONTACT

888-713-1564 cc_clinical_affairs@edwards.com

Data from ClinicalTrials.gov

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