Clinical trial NCT03604029: Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities
Official title: Evaluating the Diagnostic Performance of Near Infrared Spectroscopy (NIRS) in the Setting of Acute Compartment Syndrome (ACS) in Traumatized Lower Extremities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compartment Syndrome of Leg
Keywords: ACS
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 65 years
2. Ability to be enrolled within 12 hours of qualifying injury
3. Must have at least one uninjured upper or lower extremity
4. Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.

Anatomic Location:

1. Tibia/fibula shaft fracture
2. Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
3. Gunshot wound to leg without tibia fracture

High Energy Mechanism of Injury (MOI):

1. Fall from more than 5-foot height
2. Motor vehicle collision (more than 15mph)
3. Motor vehicle versus pedestrian accident
4. High velocity gunshot wound (with or without tibia fracture)
5. Crush injury
6. Sport/recreation

Exclusion Criteria:

1. Application of NIRS monitoring would be an impediment to care
2. Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
3. Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
4. Consent cannot be obtained from the patient or their LAR within 12 hours of injury
5. Has already undergone fasciotomy of the injured leg prior to enrollment
6. Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
7. Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
8. Is in police custody at presentation to the hospital
9. Is a woman who is pregnant
10. Has open injury on the injured leg that is large enough that at least two NIRS sensor cannot be safely placed. At a minimum two sensors must be placed on the injured leg(s).

Primary outcomes:
measure: Acute Compartment Syndrome
timeFrame: Zero to seventy two hours from enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Brett A. Freedman, Col, MD
state: Minnesota
Study officials:
affiliation: The Geneva Foundation
name: Chevas R. Yeoman, MPH
role: STUDY_DIRECTOR
affiliation: Emory Department of Orthopedics
name: William M. Reisman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Athens Orthopedic Clinic
name: Charles L. Ogburn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Anontio Military Medical Center
name: Patrick M. Osborn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Brandon J. Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.