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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Nonin Medical | UNKNOWN |
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This is a prospective observational study to determine the reliability and accuracy of Near Infrared Spectroscopy (NIRS) to detect oxygen flow in the extremities of injured and non-injured soldiers over time. This technology may be useful in the detection of acute compartment syndrome. We hypothesize that:
The purpose of this prospective observational cohort 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. Additionally, it will establish diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring. Through prospective measurements of NIRS values, vital signs, intracompartmental pressures and clinical examinations, guidelines and parameters will be established for the use of NIRS in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS and evaluating the adequacy of fasciotomy in patients treated for ACS.
Null hypotheses:
Specific Aims:
Conduct observational, human-use, study to compile a normative reference database for NIRS-measured tissue perfusion in the uninjured upper extremity and the injured and non-injured legs of up to 120 injured subjects, from varying ethnicities (skin pigmentations) in varying degrees of hemodynamic status (stable, critically injured) to test the 3 hypotheses listed above. The study groups consist of one control group (critically ill without leg injuries) and one investigational group (critically injured with leg injuries):
Record provider comments regarding usability of the technology in its new embodiment and areas of needed design improvement. Apply this knowledge to perfect the industrial design and functionality of the final device.
Establish evidenced-based clinical guidelines for the diagnosis and management of ACS in traumatically injured soldiers to be tested in a subsequent interventional clinical (IDE) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical Controls | Critically injured patients with NO "severe traumatic lower extremity" injuries to provide normative data for the "critically injured" physiological status upon arrival at study site |
| |
| Investigational cohort | Soldiers with "severe traumatic lower extremity" injuries in "stable" or "critical" physiological status presenting to a participating study site within 12 hours of their injury, to provide data on the acute post-injury phase. This cohort will be made up of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near infrared spectroscopy (NIRS) | Device | Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute compartment syndrome (ACS) | The "gold standard" criterion for ACS will be "clinical diagnosis". That is, all subjects undergoing fasciotomy for clinically diagnosed ACS (NOT PROPHYLACTIC fasciotomies) will be considered to have ACS. NIRS values will be compared to clinical diagnosis to determine accuracy and threshold values. | 24-48 hours at study site |
| Measure | Description | Time Frame |
|---|---|---|
| Intracompartmental pressure (ICP) | ICP measurements will be taken at the doctor's discretion, as this is the only existing objective diagnostic tool for ACS. When available, ICP will be compared to NIRS values to assess the magnitude of agreement between the 2 tools. | 24-48 hours at study site |
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Inclusion Criteria:
Injuries:
Mechanisms:
Exclusion Criteria:
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Critically injured patients (Cohort 1) or patients with severe lower extremity injuries (Cohort 2), admitted to one of the participating sites, who meet the eligibility criteria described below.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Cole | Contact | jandmshuler@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Brett Freedman, MD | Landstuhl Regional Medical Center | Principal Investigator |
| William Reisman, MD | Emory University | Principal Investigator |
| Bruce Ziran, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Medical Center | Atlanta | Georgia | United States |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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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| Atlanta Medical Center |
| Principal Investigator |
| Grady Memorial Hospital | Atlanta | Georgia | United States |
|
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |