Overview

This trial is active, not recruiting.

Condition acute compartment syndrome
Treatment shaving
Sponsor J&M Shuler
Collaborator Nonin Medical, Inc
Start date January 2011
End date August 2011
Trial size 42 participants
Trial identifier NCT01284023, NIRS-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
Arm
Uninjured volunteers
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

Primary Outcomes

Measure
Near infrared spectroscopy
time frame: 1 hour

Secondary Outcomes

Measure
Skin pigmentation
time frame: prior to monitoring
fat depth
time frame: prior to monitoring

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Use of Near Infrared Spectroscopy to Detect Muscle Perfusion in the Lower Extremity of Uninjured Subjects
Principal investigator Michael Shuler, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by J&M Shuler.