Personal BP - CAI Study

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

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Key information

Conditions

Blood Pressure

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Hospital

Evanston, Illinois, 60611, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Jul 9, 2024
Registry last updated: Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting