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Near Infrared Spectroscopy to Reduce the Prophylactic Fasciotomies for and Missed Cases of Acute Compartment Syndrome in Solders Injured in OEF/OIF
Technical Report,30 Sep 2013,31 Aug 2015
The Geneva Foundation Tacoma United States
Pagination or Media Count:
The research project was conducted in three-parts to validate the accuracy and reliability of a specific NIRS sensor Equanox, Nonin, Inc, Plymouth, MN in diagnosing acute compartment syndrome following severe leg injury. Part 1 was a series of observational clinical studies, the first of which was completed at Landstuhl Regional Medical Center during year 1. The primary clinical study was originally planned to be conducted in-theater OEFOIF, but had to be transitioned to a FDA-regulated study conducted under abbreviated IDE requirements in the US. This study was conducted at three trauma centers in Georgia. The study was completed and the final data analysis is reported herein. Part 1demonstrated the safety and efficacy of NIRS oximetry in diagnosing ACS, but it also identified areas for improvement. Part 2 of the project involved animal studies to address issues raised in clinical testing and to promote further understanding of NIRS response to ACS. Four animal studies were completed and they demonstrated that NIRS in a controlled in vivo setting is highly accurate in diagnosing ACS, and just as importantly, the absence of ACS in traumatized limbs. Part 3 of this project is the translation of the knowledge gained in Parts 1 and 2 into a FDA-approvable format that will be available for clinical use, to ultimately answer long unmet needs in combat casualty care
APPROVED FOR PUBLIC RELEASE