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

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Heart Valve Disease
• Intervention / Treatment: Device: CDI 1000 COM and INVOS 5100

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects ≥18 year-old of age admitted to the University Hospital setting scheduled for cardiac surgery or admitted for any cause to the Intensive Care Unit (ICU).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: 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.; Other Names: Terumo CDI 1000 COM; Somanetics INVOS 5100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To test a new device for Cerebral Oxygenation Monitoring	12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of human forehead skin during period of probe adhesion	12 hours

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Jeffrey C Milliken, MD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 24, 2007
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Estimate): September 5, 2011
• Last Update Submitted That Met QC Criteria: September 1, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Hypoxia; Cerebral Hypoxia
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Heart Valve Diseases
• Other Study ID Numbers: 2007-5840