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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Ischemia

Intervention / Treatment
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* Device: CDI 1000 COM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>Healthy subjects testing the device. | Device: CDI 1000 COM<br>* CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.<br>* Other names: Terumo CDI 1000 COM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | placement of sensor to immediately post-removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | addition of stress on sensor to removal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Oxygenation, Oxygen Monitoring