Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
Recruitment status was Not yet recruiting
|First Received Date ICMJE||February 24, 2010|
|Last Updated Date||October 17, 2011|
|Start Date ICMJE||November 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||NIRS values in lower leg extremity injury [ Time Frame: 4 days ] [ Designated as safety issue: No ]
We will monitor patients during their hospital stay from the time of admission until discharge at likey day 4.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01077934 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome|
|Official Title ICMJE||Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome|
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.
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 syndrome while simultaneously evaluating the patient with the NIRS device. This will allow us to determine if the NIRS device can accurately and reliably predict the development of acute compartment syndrome in a non-invasive, longitudinal manner.
"Access to a precise, reliable, and noninvasive method for early diagnosis of ACS would be a landmark achievement in orthopaedic and emergency medicine."
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
All Patients admitted to Grady with Unilateral Lower leg injury at risk for compartment syndrome
|Condition ICMJE||Compartment Syndrome|
|Intervention ICMJE||Device: near-infrared spectroscopy
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||200|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||13 Years to 85 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01077934|
|Other Study ID Numbers ICMJE||01-10-14b|
|Has Data Monitoring Committee||Yes|
|Responsible Party||William Reisman, Emory University|
|Study Sponsor ICMJE||J&M Shuler|
|Collaborators ICMJE||Emory University|
|Investigators ICMJE||Not Provided|
|Information Provided By||J&M Shuler|
|Verification Date||October 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP