An observational study in Acute Compartment Syndrome, sponsored by J&M Shuler. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-15.
Sponsored by J&M Shuler · Observational
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.
75 studies on the registry are indexed under Compartment Syndromes; 12 are open to participants now.
This study's planned enrollment of 300 is above the median of 110 across 30 observational studies indexed under Compartment Syndromes.
Browse Compartment Syndromes studies →J&M Shuler is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Active duty OIF/OEF military personnel who have been air evacuated from theater to Landstuhl Regional Medical Center (LRMC). Ambulatory, self-care volunteers from the LRMC outpatient spine center will be identified to serve as controls for Cohort 1.
Exclusion Criteria:
Uninjured soldiers to provide normative data for stable physiological status
Device: near-infrared spectroscopy
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.
Device: near-infrared spectroscopy
Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort.
Device: near-infrared spectroscopy
Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury)
Time frame: 24-48 hours from hospital admission
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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J&M Shuler