NCT01123798CompletedNot Applicable
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers
J&M Shuler1 site in 1 country300 target enrollmentStarted: February 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
Time Frame: 24-48 hours from hospital admission
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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