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A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00598819
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : July 7, 2010
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
University of California, Irvine

Study Description
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Brief Summary:
The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.

Condition or disease Intervention/treatment Phase
Cerebral Ischemia Device: CDI 1000 COM Phase 1

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 effectivity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers
Study Start Date : October 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy Volunteers
Healthy subjects testing the device.
 Device: CDI 1000 COM
CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
Other Name: Terumo CDI 1000 COM


Outcome Measures
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Primary Outcome Measures :
  1. Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. [ Time Frame: attachment of sensor to 24 hours post-removal ]
    Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator.

  2. Overheating of Skin Underneath Sensor. [ Time Frame: placement of sensor to 10 minutes post-removal. ]

    The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:

    • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.


  3. Overheating of Skin Underneath Sensor [ Time Frame: placement of sensor to immediately post-removal ]

    The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:

    • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.



Secondary Outcome Measures :
  1. Sensor Fits Well on Subjects Forehead [ Time Frame: placement of sensor to end of study observation ]
    How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as "yes" or "no".

  2. Sensor Attachment Under Stress [ Time Frame: addition of stress on sensor to removal. ]

    The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:

    • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

  • Healthy male or Female Volunteers
  • 18 years old or older
  • Capable and willing to operate a bicycle
  • 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

EXLUSION CRITERIA:

  • History of Cerebrovascular Disease
  • History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)
  • Pregnancy
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598819


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jeffrey Milliken, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00598819     History of Changes
Other Study ID Numbers: 2007-5593
First Posted: January 23, 2008    Key Record Dates
Results First Posted: July 7, 2010
Last Update Posted: August 17, 2011
Last Verified: August 2011

Keywords provided by University of California, Irvine:
Cerebral Oxygenation
Oxygen Monitoring

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke