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临床试验/NCT01284023
NCT01284023已完成不适用

Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

J&M Shuler1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Near infrared spectroscopy

研究概览

简要总结

Acute compartment syndrome (ACS) is a complication of lower leg trauma that occurs when the pressure inside the leg due to swelling exceeds the body's ability to provide blood to the muscle of the leg. This condition cuts off blood flow to the leg. Left untreated, the condition can result in devastating consequences including complete loss of function of the lower extremity or amputation. Near-infrared spectroscopy (NIRS)-based tissue perfusion monitors are a non-invasive means of continuously monitoring the amount of oxygen in the tissues of an injured extremity. The device utilizes harmless red light to detect the proportion of hemoglobin saturated with oxygen up to 3 cm below the skin surface. The purpose of this study will be to launch the first stages of validation of this device as a diagnostic tool for compartment syndrome, by observing this device in uninjured subjects.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • over 18 years old

排除标准

  • any current traumatic lower or upper extremity injury
  • unwilling or unable to provide written informed consent
  • history of any anatomy-altering injury or procedure to the upper or lower extremity

结局指标

主要结局

Near infrared spectroscopy

时间窗: 1 hour

Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.

次要结局

  • Skin pigmentation(prior to monitoring)
  • fat depth(prior to monitoring)

研究者

发起方
J&M Shuler
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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