The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients (NIRS)
This is a study intended to evaluate a new device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). This is a prospective observational cohort study intended to gather data using NIRS among injured and noninjured extremities over time. Additionally, this data will help in establishing diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring.
Anterior Tibial Compartment Syndrome
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Phase II The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients|
- ACS [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||May 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Critical Controls: Twenty five (25) critically injured subjects with NO "severe" traumatic lower extremity traumatic injuries to provide control data for critically injured physiological status, a state which may induce systemic, vs. regional hypoperfusion. ("Critical" CONTROLS)
Ninety five (95) total (35 Cohort 2A; 35 Cohort 2B; 25 Cohort 2C) subjects with "severe leg injuries" presenting to a participating level 1 trauma center within 12 hours of their injury, to provide data on the acute post-injury phase. (STUDY COHORT)
Subjects meeting COHORT 2 inclusion criteria, who have UNILATERAL "severe leg injuries". Unilateral injuries include patients who meet the inclusion criteria for a "severe lower extremity injury" for ONE lower extremity, with no more than a simple soft tissue injury (eg, simple laceration) on the contralateral leg.
Subjects meeting COHORT 2 inclusion criteria, who have BILATERAL lower extremity injuries, with at least one being a "severe leg injury". Bilateral injury patients include patients with at least one lower extremity injury classified as "severe" based on Cohort 2 inclusion criteria, with a contralateral injury greater than a simple soft tissue injury, including femur, foot, and crush injuries. Note that it is not necessary for both lower extremity injuries to meet the inclusion criteria to be enrolled in this cohort.
Subjects meeting COHORT 2 inclusion criteria, clinically diagnosed by the treating provider using that treating provider's standards of diagnosing ACS, and in addition to being diagnosed with ACS, the subject undergoes four-compartment leg fasciotomy. data collection to start BEFORE fasciotomy and continue AFTER fasciotomy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01547013
|United States, Georgia|
|Athens Regional Medical Center|
|Athens, Georgia, United States, 30606|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Atlanta Medical Center|
|Atlanta, Georgia, United States, 30312|
|Principal Investigator:||Brett Freedman, MD||US Army Landstuhl Regional Medical Center|