Correlation Between Muscle Oxygenation and Skin Pigmentation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measure from The INVOS cerebral oximeter and DermaSpectrometer
研究概览
简要总结
The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean arterial pressure (MAP) at time of measurements. Additional information including diseases such as diabetes and vascular disorders will be recorded. Social demographics including alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could also contribute to cardiovascular diseases. The skin pigmentation of each subject will be recorded. Two different methods will be used for this measurement. Each patient will be graded on a six point scale as described by Young (Young, 1997). Additionally, each subject will have their skin measured using a reflectance colorimeter. The colorimeter, DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of light reflected off the skin. By measuring the light reflectance, the skin pigmentation can be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual wavelength near infrared spectrometer. Using the different absorption characteristics of deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI) will be used for all measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or Female between the ages of 18 and 75 years old
- •Subjects that have no lower extremity injuries.
- •Subject who are classified as being either light or dark skin pigmentation.
- •Subjects willing to participate in the study.
排除标准
- •Patients with previous injury to either lower extremity
- •Patients with previously diagnosed vascular disease or insufficiency
- •Patients with pulmonary insufficiency or severe pulmonary injury
- •Patients not willing to consent to participate
研究组 & 干预措施
1
We will use The INVOS cerebral oximeter to determine oxygen content in the healthy muscle. In addition, we will use a the DermaSpectrometer to determine if there are differences in our readings according to skin color.
干预措施: Measure of muscle oxygenation (Device)
1
We will use The INVOS cerebral oximeter to determine oxygen content in the healthy muscle. In addition, we will use a the DermaSpectrometer to determine if there are differences in our readings according to skin color.
干预措施: Skin pigmentation determination (Device)
结局指标
主要结局
Measure from The INVOS cerebral oximeter and DermaSpectrometer
时间窗: 1 day
次要结局
未报告次要终点
研究者
Thomas Moore
Assistant Professor
Emory University
