Blood PressureNCT06492746
Personal BP - CAI Study
A study testing HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring in people with Blood Pressure, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Confirmed to be pregnant
- Surgery for congenital heart defect
- Non-availability of HemoSphere with laptop CAI interface
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University Hospital
Evanston, Illinois, 60611
Bin Zhang
About this study
Official title: Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
- Conditions
- Blood Pressure
- Being tested
- HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry MonitoringDevice
The arterial line with Acumen IQ sensor and Foresight Elite sensor will be connected to the HemoSphere monitor with laptop displaying the CAI parameter.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring | Experimental | Not described Receives: Device: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the magnitude and duration of CAI
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.
Measured: Duration of the procedure through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start3 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492746
- Sponsor's protocol ID
- 2023-15
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing for Personalized Blood Pressure Targets During Cardiopulmonary Bypass With the Proprietary Cerebral Adaptive Index: A Pilot Investigation
- ClinicalTrials.gov ID
- NCT06492746
- Acronym / sponsor ID
- 2023-15
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring | Experimental | Device: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Non-English speaking
- Confirmed to be pregnant
- Surgery for congenital heart defect
- Non-availability of HemoSphere with laptop CAI interface
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry MonitoringThe arterial line with Acumen IQ sensor and Foresight Elite sensor will be connected to the HemoSphere monitor with laptop displaying the CAI parameter. | Device | Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring in people with Blood Pressure, run by Becton, Dickinson and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Johnson (888-713-1564, cc_clinical_affairs@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the magnitude and duration of CAI (time frame: Duration of the procedure through 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.