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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Healthy subjects testing the device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDI 1000 COM | Device | CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period. |
|
| 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 |
| 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". |
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INCLUSION CRITERIA:
EXLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey C Milliken, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
Physical Exam to confirm healthy status. The physical exam was performed by the investigator that is a licensed Medical Doctor.
Healthy Volunteers
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants was determined by protocol specifications. | Posted | Jan 2010 | Number | Participants | attachment of sensor to 24 hours post-removal |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator. |
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No Adverse Events (AE's) or Serious Adverse Events (SAE's) were reported in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey C. Milliken | University of California, Irvine Medical Center | 714-456-3634 | jcmillik@uci.edu |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Jan 2010 | Number | Participants | placement of sensor to 10 minutes post-removal. |
|
|
|
| Secondary | 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". | Posted | Jan 2010 | Number | Participants | placement of sensor to end of study observation |
|
|
|
| Secondary | 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. | Posted | Jan 2010 | Number | Participants | addition of stress on sensor to removal. |
|
|
|
| Primary | 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. | Posted | Jan 2010 | Number | Participants | placement of sensor to immediately post-removal |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |