Near Infra-Red Spectroscopy to Reduce the Phrophylactic Fasciotomies for and Missed Cases of Acute Compartment Syndrome in Solders Injured in OEF/OIF

摘要

The NIRS research project is a three-part project originally planned to be completed over three years to validate the accuracy and reliability of a specific NIRS sensor (Equanox, Nonin, Inc, Plymouth, MN) in diagnosing acute compartment syndrome in injured combat soldiers. Part 1 is a series of two observational studies, the first of which was completed in Period 1. Patient will receive continuous NIRS and vital sign monitoring throughout their standard course of care, first at Landstuhl Regional Medical Center and then at 3 civilian trauma centers in Georgia. The civilian observational study is currently under IRB review and will be conducted under abbreviated FDA IDE requirements. Part 2 involves animal studies aimed at addressing issues raised in clinical testing and furthering the understanding of NIRS response to compartment syndrome. This phase of study occurred over Period 2 under IACUC and ACURO approved protocols. The final part of this project will be the translation of the current technology into a validated, FDA approved format. This requires the data collected in Parts 1 and 2, as well as ongoing regulatory steps and ultimately an investigational trial that we plan to conduct following the completion of DR080018.