Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Recruitment status was Active, not recruiting
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.
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects|
- Near infrared spectroscopy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.
- Skin pigmentation [ Time Frame: prior to monitoring ] [ Designated as safety issue: No ]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).
- fat depth [ Time Frame: prior to monitoring ] [ Designated as safety issue: No ]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)
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284023
|United States, Georgia|
|Athens Orthopedic Clinic, PA|
|Athens, Georgia, United States, 30606|
|Principal Investigator:||Michael Shuler, MD||Athens Orthopedic Clinic, PA|