ClinicalTrials.gg
RecruitingNCT06492746Updated Jul 8, 2026

Personal BP - CAI Study

An interventional study of HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring in Blood Pressure, sponsored by Becton, Dickinson and Company. Recruiting at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Becton, Dickinson and Company · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
45 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Blood Pressure
03

In context

Lead sponsor

Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed
  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, , carotid bruit, tobacco smoking, or peripheral vascular disease

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring

    Device: HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring

Interventions

  • DeviceHemoSphere 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Duration of the procedure through 30 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2024 (actual). Primary completion is estimated for Jan 2027, 31 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2024
First posted
Jul 9, 2024
StartActual
Jun 3, 2024
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06492746
Responsible party
Sponsor
First posted
Jul 9, 2024
Start date
Jun 3, 2024
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Cristina Johnson
Contact
cc_clinical_affairs@edwards.com
888-713-1564

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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