A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

University of California, Irvine21 enrolled

Overview

The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease Heart Valve Disease

Interventions

CDI 1000 COM and INVOS 5100DEVICE

CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. To be 18 years old or older 2. Scheduled for cardiac surgery 3. Treatment will include 72 hours or more of hospital stay 4. Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study Exclusion Criteria: 1. History of cerebrovascular disease 2. History of skin problems on forehead (skin rashes, acne, allergies, etc.) 3. History of craniofacial surgeries 4. Pregnancy

Locations (1)

University of California, Irvine Medical Center

Orange, California, United States

Outcomes

Primary Outcomes

To test a new device for Cerebral Oxygenation Monitoring

Time frame: 12 hours

Secondary Outcomes

Safety of human forehead skin during period of probe adhesion

Time frame: 12 hours

Data from ClinicalTrials.gov

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