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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nonin Medical
Information provided by:
J&M Shuler
ClinicalTrials.gov Identifier:
NCT01284023
First received: January 25, 2011
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Acute Compartment Syndrome
 Other: Shaving

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

Further study details as provided by J&M Shuler:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 42
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Controls
Uninjured volunteers
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284023

Locations
United States, Georgia
Athens Orthopedic Clinic, PA
Athens, Georgia, United States, 30606
Sponsors and Collaborators
J&M Shuler
Nonin Medical
Investigators
Principal Investigator: Michael Shuler, MD Athens Orthopedic Clinic, PA
  More Information

No publications provided

Responsible Party: Michael Shuler, J&M Shuler
ClinicalTrials.gov Identifier: NCT01284023     History of Changes
Other Study ID Numbers: NIRS-02
Study First Received: January 25, 2011
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by J&M Shuler:
near infrared spectroscopy
acute compartment syndrome

Additional relevant MeSH terms:
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013