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

Tracking Information
First Submitted Date	January 25, 2011
First Posted Date	January 26, 2011
Last Update Posted Date	March 17, 2017
Study Start Date	January 2011
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 25, 2011)	Near infrared spectroscopy [ Time Frame: 1 hour ]; Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01284023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: January 25, 2011)	Skin pigmentation [ Time Frame: prior to monitoring ]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 ]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)
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Official Title	Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Other; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Uninjured volunteers will be recruited from a pool of uninjured individuals at the principle investigator's practice. Participation will be completely volutnary
Condition	Acute Compartment Syndrome
Intervention	Other: Shaving; 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
Study Groups/Cohorts	Controls; Uninjured volunteers; Intervention: Other: Shaving
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Estimated Enrollment; (submitted: January 25, 2011)	42
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	December 2017
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01284023
Other Study ID Numbers	NIRS-02
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	J&M Shuler
Study Sponsor	J&M Shuler
Collaborators	Nonin Medical, Inc
Investigators	Principal Investigator: Michael Shuler, MD Athens Orthopedic Clinic, PA
PRS Account	J&M Shuler
Verification Date	March 2017