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Completed

NCT Number: NCT01284023

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.

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Key information

Conditions

Acute Compartment Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Athens Orthopedic Clinic, PA

Athens, Georgia, 30606, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Near infrared spectroscopy

    Time frame: 1 hour

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

Secondary outcomes

  1. Skin pigmentation

    Time frame: 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).

  2. fat depth

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

J&M Shuler

Industry

Collaborators

  • Nonin Medical, Inc

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 26, 2011
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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