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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
University of California, Irvine Medical Center
Orange, California, United States
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.
Time frame: attachment of sensor to 24 hours post-removal
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.
Time frame: placement of sensor to 10 minutes post-removal.
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.
Time frame: placement of sensor to immediately post-removal
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".
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Time frame: placement of sensor to end of study observation
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.
Time frame: addition of stress on sensor to removal.