Personal BP - CAI Study

Not Applicable

Recruiting

• Conditions: Blood Pressure
• Interventions: Device: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

• Registration Number: NCT06492746
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring	HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring	-

Primary Outcome Measures

Name	Time	Method
To determine the magnitude and duration of CAI	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.

Trial Locations

Locations (1)

Northwestern University Hospital; 🇺🇸 Evanston, Illinois, United States