Accession Number:

ADA612341

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. 30 Sep 2013-31 Aug 2014

Corporate Author:

GENEVA FOUNDATION TACOMA WA

Personal Author(s):

Report Date:

2014-10-01

Pagination or Media Count:

21.0

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. This study was established in Period 3 and completed in Period 4. Part 2 of the project involves animal studies to address issues raised in clinical testing and furthering understanding of NIRS response to ACS. Three informative animal studies were completed and the results of which have been presented over the grant period. Part 3 of this project is the translation of the current technology into a validated, FDA approvable 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 following the completion of this grant.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE