UnknownNot Applicable

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

United States300 participantsStarted 2019-01-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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
✓. Fall from more than 5-foot height

Exclusion criteria

✕. 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

What they're measuring

Acute Compartment Syndrome

Timeframe: Zero to seventy two hours from enrollment.

Trial details

NCT IDNCT03604029

SponsorNonin Medical, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Compartment Syndrome of Leg trials