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

NCT ID: NCT00598936

Last Updated: 2011-09-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-05-31

Brief Summary

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

Detailed Description

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.

Conditions

Coronary Artery Disease; Heart Valve Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac Surgery or Hospitalization

Patients scheduled for a Cardiac Surgery procedure, two types of cerebral oximetry devices were compared at the same time during the surgical procedure.

The second group were patients hospitalized (in the Intensive Care Unit or ICU, with any diagnosis, excluding head trauma patients. Those patients were monitored using two types of cerebral oximetry devices at the same time for up to 72 hours.

CDI 1000 COM and INVOS 5100

Intervention Type: DEVICE

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.

Interventions

CDI 1000 COM and INVOS 5100

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.

Intervention Type: DEVICE

Other Intervention Names

Terumo CDI 1000 COM; Somanetics INVOS 5100

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey C Milliken, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

2007-5840

Identifier Type: -

Identifier Source: org_study_id