Status:
UNKNOWN
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome
Lead Sponsor:
J&M Shuler
Collaborating Sponsors:
United States Department of Defense
Nonin Medical
Conditions:
Acute Compartment Syndrome
Eligibility:
All Genders
15-65 years
Brief Summary
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 ov...
Detailed Description
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 in...
Eligibility Criteria
Inclusion
- male or female subjects
- between the ages of 15 and 65 years old
- (Cohort 1 only) Admitted directly to the ICU of a participating study site
- (Cohort 2 only) Admitted to a participating study site with the following injury/mechanism combinations:
- Injuries:
- Segemental tibia shaft fracture
- Comminuted tibia shaft fracture
- Schatzker Type III-VI tibial plateau fractures
- Mechanisms:
- Fall from a height of \>= 8 feet
- Motor vehicle or motorcycle crash
- Pedestrian versus automobile
Exclusion
- Patients, in whom application of NIRS monitoring is viewed as an impediment to care.
- Patients with known prior leg fractures (not related to current injury)
- History of peripheral vascular disease or lower extremity vascular surgery.
- Amputation
- Diagnoses with ACS prior to enrollment
- Spinal injuries resulting in complete loss of function
- Mangled lower extremity
- Bilateral upper extremity injuries
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01171638
Start Date
September 1 2011
End Date
December 1 2012
Last Update
June 15 2011
Active Locations (2)
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1
Atlanta Medical Center
Atlanta, Georgia, United States
2
Grady Memorial Hospital
Atlanta, Georgia, United States