Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
NCT Number: NCT06512870
Acronym: NIRS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Compartment Syndromes
Interventions: DIAGNOSTIC_TEST: Near infrared spectroscopy (NIRS)
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-11-01
Completion Date: 2026-11-01

Summary:
Near infrared spectroscopy (NIRS), a technique that relies on differential absorption of infrared light to provide relative estimation of tissue oxygenation, has been successfully used to monitor perfusion of various tissues, including muscle tissue of the lower extremity, however available research reports mixed success and this technology is not currently a standard of care for patients with leg fractures.

The investigators propose use of NIRS technology in patients with diagnosis of tibial fracture and acute compartment syndrome to detect / document impaired perfusion of the anterior compartment of the leg, as compared to their non-broken leg. The investigators also propose measurement of intramuscular glucose level in the affected leg and compare it to a fingerstick glucose to detect relative hypoglycemia in the affected muscular compartment. If proven effective, NIRS, or IM glucose, or both techniques could be used for clinical monitoring of patients with tibial fractures at risk for acute compartment syndrome.

Primary Outcome Measures: Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise., NIRS sensors will be applied to the skin overlying anterior compartment of the injuries and uninjured legs. Uninjured leg will serve as a control leg. Readings from both legs will be recorded continuously until patient enters OR for emergent surgery. At that point NIRS sensor will be removed to allow skin prep for surgical procedure. NIRS sensor will be re-applied to the skin at the completion of the surgery before leg is wrapped with the dressing. Monitoring of both extremities will be continued for 72 hours.

If NIRS readings of the affected extremity will be reliably lower as compared to unaffected extremity, and that difference will reverse after surgery (fasciotomy), where NIRS reading of the affected extremity should be at least equal to or, most likely, higher than those of the unaffected extremity, that will prove that NIRS monitoring can be used to detect acute compartment syndrome and muscular ischemia., 72 hours|Use of point-of-care IM glucose to document relative hypoglycemia in the anterior compartment of the affected leg as an indicator of ACS and/or tissue ischemia., When incision is made by the surgeon, upon entering the anterior muscular-fascial compartment, surgeon will obtain small drop of blood (by aspiration with a 2 ml syringe from the cut surface of the muscle) and pass it on to the study personnel to apply it onto the test strip for glucose measurement. At the same time fingerstick will be performed and capillary glucose will be measured. Both glucose readings will be recorded.

If intramuscular glucose readings in the affected extremity show relative hypoglycemia, i.e. glucose in the affected compartment will be lower than the fingerstick performed at the hand at the same time, that will prove that intramuscular glucose monitoring can be used to detect acute compartment syndrome and muscular ischemia., once, intraoperatively