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临床试验/NCT00747162
NCT00747162撤回4 期

Correlation Between Muscle Oxygenation and Skin Pigmentation

Emory University2 个研究点 分布在 1 个国家开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Moore

Assistant Professor

Emory University

研究点 (2)

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