A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Healthy Volunteers
Healthy subjects testing the device.
干预措施: CDI 1000 COM (Device)
结局指标
主要结局
Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
- Sensor Fits Well on Subjects Forehead(placement of sensor to end of study observation)
- Sensor Attachment Under Stress(addition of stress on sensor to removal.)