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

This study has been terminated.
(Investigator considered the device with no clinical utility.)
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00598936
First received: December 24, 2007
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Heart Valve Disease
Device: CDI 1000 COM and INVOS 5100
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To test a new device for Cerebral Oxygenation Monitoring [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of human forehead skin during period of probe adhesion [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: November 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598936

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Jeffrey C Milliken, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00598936     History of Changes
Other Study ID Numbers: 2007-5840
Study First Received: December 24, 2007
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Hypoxia
Cerebral Hypoxia

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Valve Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014