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

Acute Compartment Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284023
• Other study ID #: NIRS-02
• Status: Completed
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2018
• Source: J&M Shuler
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes

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

Locations

Country	Name	City	State
United States	Athens Orthopedic Clinic, PA	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
J&M Shuler	Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near infrared spectroscopy	Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.	1 hour
Secondary	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
Secondary	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