Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities

Status unconfirmed

Conditions studied: Compartment Syndrome of Leg

In brief

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.

Key facts

Study ID

NCT03604029

Run by

Nonin Medical, Inc

People needed

300

Starts

2019-01-07

Expected to finish

2022-02-28

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 to 65 years
• Ability to be enrolled within 12 hours of qualifying injury
• Must have at least one uninjured upper or lower extremity
• Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.
• Anatomic Location:
• Tibia/fibula shaft fracture
• Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
• Gunshot wound to leg without tibia fracture
• High Energy Mechanism of Injury (MOI):
• Fall from more than 5-foot height
• Motor vehicle collision (more than 15mph)
• Motor vehicle versus pedestrian accident
• High velocity gunshot wound (with or without tibia fracture)
• Crush injury
• Sport/recreation

You may not qualify if…

• Application of NIRS monitoring would be an impediment to care
• Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
• Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
• Consent cannot be obtained from the patient or their LAR within 12 hours of injury
• Has already undergone fasciotomy of the injured leg prior to enrollment
• Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
• Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
• Is in police custody at presentation to the hospital
• Is a woman who is pregnant
• 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).

Where it is running

• Brett A. Freedman, Col, MD — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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