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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by J&M Shuler.
Recruitment status was  Active, not recruiting
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

January 25, 2011
October 17, 2011
January 2011
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01284023 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Uninjured volunteers will be recruited from a pool of uninjured individuals at the principle investigator's practice. Participation will be completely volutnary

Acute Compartment Syndrome
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
Controls
Uninjured volunteers
Intervention: Other: Shaving
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
January 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284023
NIRS-02
No
Michael Shuler, J&M Shuler
J&M Shuler
Nonin Medical
Principal Investigator: Michael Shuler, MD Athens Orthopedic Clinic, PA
J&M Shuler
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP