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Recruiting

NCT Number: NCT06492746

Personal BP - CAI Study

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

Recruiting

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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

Location contact

Bin Zhang

CONTACT

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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Johnson

CONTACT

[email protected]

888-713-1564

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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