Assessing personalized blood pressure targets using advanced monitoring
Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
NA · Edwards Lifesciences · NCT06492746
This study is testing a new way to set personalized blood pressure goals for high-risk patients during heart surgery to see if it can improve their recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Edwards Lifesciences (industry) |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT06492746 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the Cerebral Adaptive Index for determining personalized blood pressure targets in patients undergoing cardiac surgery with cardiopulmonary bypass. It involves the use of the HemoSphere Advanced Monitoring Platform equipped with Acumen IQ sensors and Tissue Oximetry Monitoring to gather data. The study is observational and focuses on high-risk patients to improve blood pressure management during surgery. By analyzing individual responses, the study seeks to tailor blood pressure targets to enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45 and older who are scheduled for cardiac surgery and have a high risk for cerebral vascular disease.
Not a fit: Patients who are non-English speaking, pregnant, or undergoing surgery for congenital heart defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective blood pressure management during cardiac surgeries, potentially reducing complications.
How similar studies have performed: While this approach is innovative, similar studies focusing on personalized monitoring in surgical settings have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Evanston, Illinois
- Northwestern University Hospital — Evanston, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Cristina Johnson
- Email: cc_clinical_affairs@edwards.com
- Phone: 888-713-1564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Pressure