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Accession Number:
ADA570065
Title:
Near-infrared Spectroscopy to Reduce Prophylactic Fasciotomies for and Missed Cases of Acute Compartment Syndrome in Soldiers Injured in OEF/OIF
Descriptive Note:
Annual rept. 1 Oct 2011-30 Sep 2012
Corporate Author:
GENEVA FOUNDATION TACOMA WA
Report Date:
2012-10-01
Pagination or Media Count:
44.0
Abstract:
The research project is a three-part project 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 at Landstuhl Regional Medical Center during year 1. The second clinical study was originally planned to be conducted in theatre in Afghanistan and Iraq, but had to be transitioned to a FDA-regulated study conducted under an abbreviated IDE within the USA. In the current reporting period this study was implemented at three trauma centers in Georgia. The study is well underway with 44 of the subjects required by the protocol enrolled. We are on track for completing the study within the third quarter of the extended fourth year. Part 2 of the project involves animal studies to address issues raised in clinical testing and furthering understanding of NIRS response to ACS. The first animal study was completed in Year 2 of this award, and a second study using a different ACS model was completed in the current reporting period. Part 3 of this project is the translation of the current technology into a validated, FDA approved format. Data collected in Parts 1 and 2 will be used as the basis for developing a NIRS-based diagnostic algorithm that will be validated in a subsequent clinical trial.
Distribution Statement:
APPROVED FOR PUBLIC RELEASE
