The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers

NCT01123798 — Completed, 300 participants, J&M Shuler

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT01123798
Status	Completed
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	J&M Shuler (Industry); collaborators: United States Department of Defense, Somanetics Corporation
Conditions	Acute Compartment Syndrome
Interventions	near-infrared spectroscopy (Device)
Dates	start 2010-02-01, primary completion 2011-01-01, completion 2011-01-01, first posted 2010-05-14, last updated 2011-06-15
Locations	1 site in Germany

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Interventions	Description
Stable controls	Device: near-infrared spectroscopy	Uninjured soldiers to provide normative data for stable physiological status
Critical controls	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.
Lower extremity trauma	Device: near-infrared spectroscopy	Soldiers with severe traumatic lower extremity injuries in stable and shock physiologic status. This is the investigational cohort.

near-infrared spectroscopy (Device): Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.

+Outcome measures

Primary outcomes

NIRS values in various physiologic states (stable control, critically injured control, lower extremity injury) [24-48 hours from hospital admission]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Landstuhl Regional Medical Center	Landstuhl	Germany

+Investigators

Brett Freedman, MD, Principal investigator, Landstuhl Regional Medical Center

My Notes

Public

To Read Reading Read