A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cerebral Ischemia |
Device: CDI 1000 COM |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers |
- 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 ] [ Designated as safety issue: Yes ]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.
- Overheating of Skin Underneath Sensor. [ Time Frame: placement of sensor to 10 minutes post-removal. ] [ Designated as safety issue: Yes ]
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.
- Overheating of Skin Underneath Sensor [ Time Frame: placement of sensor to immediately post-removal ] [ Designated as safety issue: Yes ]
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.
- Sensor Fits Well on Subjects Forehead [ Time Frame: placement of sensor to end of study observation ] [ Designated as safety issue: No ]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".
- Sensor Attachment Under Stress [ Time Frame: addition of stress on sensor to removal. ] [ Designated as safety issue: No ]
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.
| Enrollment: | 14 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, California | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Jeffrey C Milliken, MD | University of California, Irvine |
More Information
No publications provided
| Responsible Party: | Jeffrey Milliken, MD, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00598819 History of Changes |
| Other Study ID Numbers: | 2007-5593 |
| Study First Received: | December 19, 2007 |
| Results First Received: | January 15, 2010 |
| Last Updated: | August 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Cerebral Oxygenation Oxygen Monitoring |
Additional relevant MeSH terms:
|
Cerebral Infarction Brain Ischemia Ischemia Brain Infarction Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013