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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Compartment Syndrome

Intervention / Treatment
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* Other: Shaving


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Uninjured volunteers | Other: Shaving<br>* Male patients will have the leg hair under each sensor site shaved, using an electric razor, and near infrared spectroscopy monitored for an additional 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near infrared spectroscopy | Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin pigmentation | due to absorption of hemoglobin and melanin at near infrared wavelengths, skin pigmentation may affect near infrared spectroscopy values. Skin pigmentation values will be recorded on each study participant using the DSM-II (CyberDerm, Broomall, PA) and the IMS SmartProbe (IMS, Portland, ME). | prior to monitoring | 
| fat depth | because the near infrared spectroscopy device measures tissue oxygenation 2-3 cm below the skin, the device may obtain an altered reading or be unable to obtain a reading on subjects with excessive subcutaneous fat. Data on fat depth will be collected on control subjects using the BX2000 (IntelaMetrix, Livermore, CA) | prior to monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near infrared spectroscopy, acute compartment syndrome