Personal BP - CAI Study
ConditionBlood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorBecton, Dickinson and Company
About this trial
A single-center, prospective, observational pilot of the Cerebral Adaptive Index for assessing personalized blood pressure targets
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Age ≥ 45 years
Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
Planned monitoring with ForeSight sensor and HemoSphere monitor
Disqualifiers
Non-English speaking
Confirmed to be pregnant
Surgery for congenital heart defect
Non-availability of HemoSphere with laptop CAI interface
Trial design
Design model
Single group
Treatments tested in this trial
HemoSphere Advanced Monitoring Platform with Acumen IQ sensor and Tissue Oximetry Monitoring
DeviceThe arterial line with Acumen IQ sensor and Foresight Elite sensor will be connected to the HemoSphere monitor with laptop displaying the CAI parameter.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoringExperimental treatment 1 intervention
Trial outcomes
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov