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This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). We have shown NIRS can be helpful in diagnosing ACS. We think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. We have studied the capabilities of NIRS for many years. The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines. The goal of this study is to test and prove our clinical guidelines we developed through previous work. This is an interventional study, which means the data we collect will be used to manage the patient and their care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualifying Subjects | Qualifying subjects who are high risk for ACS. |
| |
| Qualifying Subjects with ACS | Qualifying subjects who are diagnosed with ACS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Spectroscopy | Device | Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Compartment Syndrome | The subject develops and diagnosed with Acute Compartment Syndrome | Zero to seventy two hours from enrollment. |
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Inclusion Criteria:
Anatomic Location:
High Energy Mechanism of Injury (MOI):
Exclusion Criteria:
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Subjects will be recruited from the trauma bay, surgical wards and ICU of the four participating facilities. This study will enroll approximately 300 subjects over four sites: Piedmont Athens Regional Medical Center, Grady Memorial Hospital, Mayo Clinic, and San Antonio Military Medical Center, over a period of approximately 24 months.
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| Name | Affiliation | Role |
|---|---|---|
| Chevas R. Yeoman, MPH | The Geneva Foundation | Study Director |
| William M. Reisman, MD | Emory Department of Orthopedics | Principal Investigator |
| Charles L. Ogburn, MD | Athens Orthopedic Clinic | Principal Investigator |
| Patrick M. Osborn, MD | San Anontio Military Medical Center | Principal Investigator |
| Brandon J. Yuan, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brett A. Freedman, Col, MD | Rochester | Minnesota | 55901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26837078 | Result | Reisman WM, Shuler MS, Roskosky M, Kinsey TL, Freedman BA. Use of Near-Infrared Spectroscopy to Detect Sustained Hyperaemia Following Lower Extremity Trauma. Mil Med. 2016 Feb;181(2):111-5. doi: 10.7205/MILMED-D-14-00689. | |
| 29855235 | Result | Shuler MS, Roskosky M, Kinsey T, Glaser D, Reisman W, Ogburn C, Yeoman C, Wanderman NR, Freedman B. Continual near-infrared spectroscopy monitoring in the injured lower limb and acute compartment syndrome: an FDA-IDE trial. Bone Joint J. 2018 Jun 1;100-B(6):787-797. doi: 10.1302/0301-620X.100B6.BJJ-2017-0736.R3. |
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We do not plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |