A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
- Conditions
- Cerebral Ischemia
- Interventions
- Device: CDI 1000 COM
- Registration Number
- NCT00598819
- Lead Sponsor
- University of California, Irvine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy Volunteers CDI 1000 COM Healthy subjects testing the device.
- Primary Outcome Measures
Name Time Method Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. 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.
Overheating of Skin Underneath Sensor. 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.Overheating of Skin Underneath Sensor 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
Name Time Method Sensor Fits Well on Subjects Forehead 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".
Sensor Attachment Under Stress 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.
Trial Locations
- Locations (1)
University of California, Irvine Medical Center
🇺🇸Orange, California, United States