Recruiting NCT06492746
Personal BP - CAI Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring.
- Who it may be relevant to
- Registry conditions: Blood Pressure. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
Overview
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
Interventions
- Device HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring
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 outcome measures
- To determine the magnitude and duration of CAI [Time frame: Duration of the procedure through 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Northwestern University Hospital — Evanston
Identifiers
NCT: NCT06492746 · 2023-15