Observational Study on NIRS and Glucose Levels for Leg Perfusion
This study is looking at new ways to detect problems with blood flow (perfusion) in the leg for people with a broken shin bone (tibial fracture) or a condition called acute compartment syndrome. Researchers will use Near-Infrared Spectroscopy (NIRS), a technique that uses light to estimate oxygen levels in tissue, and measure glucose (sugar) levels directly from the muscle. The goal is to see if these methods can accurately show when blood flow is impaired. You might be able to join if you are between 18 and 75 years old, have a tibial fracture or fracture-dislocation with acute compartment syndrome, or a leg injury with lost pulses, and only one leg is affected. The study is currently unclear about its recruitment status and aims to enroll 10 participants.
- Study design
- This is an observational study, meaning researchers will watch and record information without giving new treatments. It plans to include 10 participants.
- What's involved
- If you join, NIRS sensors will be placed on your injured and uninjured leg, and readings will be taken until you go into surgery. Point-of-care glucose measurements will be taken once during surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- NIRS measurements will be taken for up to 72 hours. Glucose levels will be measured once, during surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise.72 hours
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.
- 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.once, intraoperatively
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.