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Completed

NCT Number: NCT00598819

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

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.

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Key information

Conditions

Cerebral Ischemia Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDI 1000 COM

Device

CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.

Other names: Terumo CDI 1000 COM

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 23, 2008
Registry last updated
Aug 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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