Cerebral Ischemia
Conditions
Keywords
Cerebral Oxygenation, Oxygen Monitoring
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.
Interventions
DEVICECDI 1000 COM
CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Healthy Volunteers
Pre-assignment details
Physical Exam to confirm healthy status. The physical exam was performed by the investigator that is a licensed Medical Doctor.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Healthy Volunteers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: attachment of sensor to 24 hours post-removal
Population: The number of participants was determined by protocol specifications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Volunteers | Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. | Harm caused by sensor | 0 Participants |
| Healthy Volunteers | Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. | No harm caused by sensor | 14 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.
Time frame: placement of sensor to immediately post-removal
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Volunteers | Overheating of Skin Underneath Sensor | Overheating underneath sensor | 0 Participants |
| Healthy Volunteers | Overheating of Skin Underneath Sensor | No overheating underneath sensor | 14 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.
Time frame: placement of sensor to 10 minutes post-removal.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Volunteers | Overheating of Skin Underneath Sensor. | Overheating underneath sensor | 0 Participants |
| Healthy Volunteers | Overheating of Skin Underneath Sensor. | No overheating underneath sensor | 14 Participants |
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.
Time frame: addition of stress on sensor to removal.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Volunteers | Sensor Attachment Under Stress | Sensor gave out under stress | 0 Participants |
| Healthy Volunteers | Sensor Attachment Under Stress | Sensor held up to stress | 14 Participants |
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.
Time frame: placement of sensor to end of study observation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthy Volunteers | Sensor Fits Well on Subjects Forehead | Sensor fit well | 14 Participants |
| Healthy Volunteers | Sensor Fits Well on Subjects Forehead | Sensor did not fit well | 0 Participants |