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

NCT01284023 | Completed

• 1 other identifier: NIRS-02
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Compartment Syndrome

Keywords

near infrared spectroscopy; acute compartment syndrome

Outcome Measures

Primary Outcomes (1)

• Near infrared spectroscopy

  Uninjured subjects will lay supine and be monitored for two one hour periods, on separate days.

  1 hour

Secondary Outcomes (2)

• Skin pigmentation

  prior to monitoring

• fat depth

  prior to monitoring

Study Arms (1)

Controls

Uninjured volunteers

Other: Shaving

Interventions

Shaving OTHER

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

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• over 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• J&M Shuler: lead
• Nonin Medical, Inc: collaborator

Study Sites (1)

Athens Orthopedic Clinic, PA

Athens, Georgia, 30606, United States

Location

Study Officials

• Michael Shuler, MD

  Athens Orthopedic Clinic, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2012
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)