Clinical Trial: Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome

Brief Summary: The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. We hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.

Detailed Summary:

Acute compartment syndrome (ACS) is associated with lower leg trauma in up to 20% of high energy injuries. ACS occurs when the pressure due to swelling exceeds the perfusion pressure thereby cutting off blood flow to the leg. If untreated, the results can be catastrophic with an insensate, contracted leg. Moreover, there is a high risk of subsequent infection and even amputation. The treatment for ACS, a four compartment fasciotomy, is aimed at releasing the pressure through two incisions from roughly the knee to the ankle. Often due to wound expansion, the incisions require multiple debridements and skin grafting to close. With fasciotomies, fractures are converted from closed to open injuries. When left open for many days, the risk of infection and complications such as nonunion increase significantly.

The only accepted objective method for diagnosis of ACS is to measure the pressure inside the leg compartments by using a large gauge needle hooked to a pressure monitor. However, these readings can be erroneous if not performed correctly. As such, ACS continues to be a clinical diagnosis which is made based on the surgeon's experience and their interpretation of the character of the injury (high-energy, motorcycle crash, vs. low-energy, a twisted ankle). Clinicians are left to attempt to interpret physical exam findings and readings from pressure monitors. Most importantly ACS is not an event, but a process that can manifest at multiple points after injury. The most accurate and effective method for diagnosing and appropriately treating ACS is serial examination over a course of hours to days.

With this study, we hope to evaluate the NIRS device, which is non-invasive, as diagnostic tool in the evaluation of acute compartment syndrome. We plan to evaluate all patients by the gold standard in diagnosing acute compartment s
Sponsor: J&M Shuler

Current Primary Outcome: NIRS values in lower leg extremity injury [ Time Frame: 4 days ]

We will monitor patients during their hospital stay from the time of admission until discharge at likey day 4.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: J&M Shuler

Dates:
Date Received: February 24, 2010
Date Started: November 2011
Date Completion:
Last Updated: April 24, 2015
Last Verified: April 2015