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

September 1, 2011 updated by: University of California, Irvine
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 hours
12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-5840

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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