The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients
Status unconfirmed
Conditions studied: Anterior Tibial Compartment Syndrome
In brief
This is a study intended to evaluate a new 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). This is a prospective observational cohort study intended to gather data using NIRS among injured and noninjured extremities over time. Additionally, this data will help in establishing diagnostic perfusion value thresholds to be used in a subsequent interventional study confirming the efficacy of NIRS-based ACS monitoring.
Key facts
- Study ID
- NCT01547013
- Run by
- U.S. Army Medical Research and Development Command
- People needed
- 130
- Starts
- 2012-02-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-03-26
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-60 years of age
- Admitted to a participating trauma center (Grady, AMC, ARMC) within 12 hours of injury
- At least one uninjured upper extremity
- Patients enrolled in Cohort 2 will have a "severe leg injury" (must be one of the following locations and MOI):
- Anatomic Location:
- Tibia/fibula shaft fracture
- Tibial plateau fracture (Schatzker III-VI) 2. High Energy Mechanism of Injury (MOI):
- Fall from >8 foot height
- Motor vehicle collision (>15mph)
- Motor vehicle versus pedestrian accident
- High velocity gunshot wound
- Crush injury
- Sport/recreation
- Patients enrolled in Cohort 1 will meet the criteria listed below:
- No bony or vascular lower extremity injury (including femur or foot fractures)
- Admitted to the ICU for a traumatic injury (not a medical problem, such as a heart attack)
- ICU stay for at least 48 hours(patients with < 2 hours of data will be excluded)
- Patients will also be selected for each cohort (See Groups/Cohorts Section).
You may not qualify if…
- NIRS monitoring impediment to care
- Known prior leg fractures (not related to current injury)
- Peripheral vascular disease history or concurrent lower extremity vascular injury/surgery
- Admission for medical reasons - atraumatic (ie. myocardial infarction, sepsis…)
- Less 18 years old or greater than 60 years old
- Unable to provide informed consent, or consent cannot be obtained from a legally authorized representative, within 12 hours of injury or prior to first leg surgery, whichever comes first
- Amputation/Mangled Lower Extremity
- Previous fasciotomy history of the injured leg prior to enrollment
- Complete spinal cord injuries
- Bilateral upper extremity injuries
- Participants who are in custody at presentation to the hospital
- Pregnancy
- Open injury on the injured leg that is large enough that at least one NIRS sensor cannot be safely placed over the compartment
- Spanish-speaking subjects who do not speak English will NOT be excluded. A certified translated copy of the informed consent document will used and a translator will be present for Spanish-speaking patients.
Where it is running
- Athens Regional Medical Center — Athens, Georgia, United States
- Grady Memorial Hospital — Atlanta, Georgia, United States
- Atlanta Medical Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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