A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
Primary Purpose
Cerebral Ischemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CDI 1000 COM
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Ischemia focused on measuring Cerebral Oxygenation, Oxygen Monitoring
Eligibility 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
Sites / Locations
- University of California, Irvine Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Volunteers
Arm Description
Healthy subjects testing the device.
Outcomes
Primary Outcome Measures
Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.
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.
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
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
Sensor Fits Well on Subjects Forehead
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
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.
Full Information
NCT ID
NCT00598819
First Posted
December 19, 2007
Last Updated
August 15, 2011
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00598819
Brief Title
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
Official Title
A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia
Keywords
Cerebral Oxygenation, Oxygen Monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Healthy subjects testing the device.
Intervention Type
Device
Intervention Name(s)
CDI 1000 COM
Other Intervention Name(s)
Terumo CDI 1000 COM
Intervention Description
CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
Primary Outcome Measure Information:
Title
Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.
Description
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.
Time Frame
attachment of sensor to 24 hours post-removal
Title
Overheating of Skin Underneath Sensor.
Description
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.
Time Frame
placement of sensor to 10 minutes post-removal.
Title
Overheating of Skin Underneath Sensor
Description
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.
Time Frame
placement of sensor to immediately post-removal
Secondary Outcome Measure Information:
Title
Sensor Fits Well on Subjects Forehead
Description
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".
Time Frame
placement of sensor to end of study observation
Title
Sensor Attachment Under Stress
Description
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.
Time Frame
addition of stress on sensor to removal.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey C Milliken, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
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