Near-infrared Spectroscopy to Reduce the Prophylactic Fasciotomies for and Missed Cases of Acute Compartment Syndrome in Soldiers Injured in OEF/OIF
Abstract
The near-infrared spectroscopy (NIRS) research project is a three-part project over three years, intended to validate the accuracy and reliability of a specific NIRS sensor (INVOS, Somanetics Inc, Troy, MI) in diagnosing acute compartment syndrome in injured combat soldiers. Part 1 is a planned series of two 6-month observational studies. Patients will receive continuous NIRS and vital sign monitoring throughout their standard course of care, first at Landstuhl Regional Medical Center and then at frontline combat support hospitals in Afghanistan. This Phase 1 of Part 1 has been initiated and is nearing completion. The Phase 2 observational study is currently under review by the Medical Research and Material Command (MRMC) Institutional Review Board (IRB) review. 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 will occur in Period 2 under Institutional Animal Care and Use Committee (IACUC) approved protocols, which have also been approved by the Animal Care and Use Review Office (ACURO). The final part of this project will be the translation of the current technology into a proven format, approved by the Food and Drug Administration (FDA). This requires the data collected in parts 1 and 2, as well as ongoing regulatory steps and iterative maturation of the interpretation of NIRS data in the diagnosis of acute compartment syndrome (ACS).
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2010
- Accession Number
- ADA552068
Entities
People
- Brett Freedman