NCT06492746

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

July 1, 2024

Last Update Submit

July 9, 2025

Conditions

Blood Pressure

Outcome Measures

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.

    Duration of the procedure through 30 days

Study Arms (1)

Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring

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

Interventions

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.

Cardiopulmonary bypass patients receiving blood pressure and oximetry monitoring

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking
  • Confirmed to be pregnant
  • Surgery for congenital heart defect
  • Non-availability of HemoSphere with laptop CAI interface

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Hospital

Evanston, Illinois, 60611, United States

RECRUITING

Central Study Contacts

Cristina Johnson

CONTACT

888-713-1564cc_clinical_affairs@edwards.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

June 3, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations

US(1)