The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 2011
- Device: near-infrared spectroscopy
- Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
Arms, Groups and Cohorts
- Stable controls
- Uninjured soldiers to provide normative data for stable physiological status
- Critical controls
- Critically injured soldiers with no lower extremity traumatic injuries (excepting skin abrasions and small/superficial fragmentation wounds) to provide normative data for the “shock” physiological status.
- Lower extremity trauma
- Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort.
Clinical Trial Outcome Measures
- NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
- Time Frame: 24-48 hours from hospital admission
Participating in This Clinical Trial
- 18-65 years old – male or female – active duty servicemen who have been evacuated from OIF or OEF through LRMC Exclusion Criteria:
- patients not willing to provide consent – patients in whom application of NIRS monitoring is viewed as an impediment to casualty care
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- J&M Shuler
- United States Department of Defense
- Provider of Information About this Clinical Study
- Brett Freedman, MAJ MC (MD), Landstuhl Regional Medical Center
- Overall Official(s)
- Brett Freedman, MD, Principal Investigator, Landstuhl Regional Medical Center
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.