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

Completed

• Conditions: Acute Compartment Syndrome
• Interventions: Other: Shaving

• Registration Number: NCT01284023
• Lead Sponsor: J&M Shuler

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 available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2011-12
• Study Completion: 2012-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Shaving	Uninjured volunteers

Primary Outcome Measures

Name	Time	Method
Near infrared spectroscopy	1 hour	Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.

Secondary Outcome Measures

Name	Time	Method
Skin pigmentation	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	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)

Trial Locations

Locations (1)

Athens Orthopedic Clinic, PA; 🇺🇸 Athens, Georgia, United States