Using NIRS to Detect Compartment Syndrome in Leg Fractures
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
Recruiting
Observational Study
Compartment Syndromes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
10 (estimated)
Sponsor
University of Florida · Other
Who this trial is looking for
This trial is looking for adults with a tibial fracture and signs of acute compartment syndrome. Participants will help researchers see if special technology and glucose levels can measure blood flow in the muscle of the injured leg.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with a tibial fracture.
I have acute compartment syndrome or a vascular injury.
I only have one leg affected.
The muscle depth in my leg is less than 2.5 cm.
I am willing to consent to the study.
You may not be able to join if
I am younger than 18 years old or older than 75 years old.
I have skin damage or an infection on my leg.
The muscle depth in my leg is more than 3 cm.
I have had surgery on the affected leg.
I cannot provide informed consent.
I cannot read or understand spoken English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 18 years of age to 75 years of age
2. Diagnosis of tibial fracture or fracture-dislocation complicated by diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
3. Unilateral injury (i.e…
Inclusion Criteria:
1. 18 years of age to 75 years of age
2. Diagnosis of tibial fracture or fracture-dislocation complicated by diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
3. Unilateral injury (i.e. only one leg is affected)
5\) Depth of anterior compartment of the leg \< 2.5 cm (as measured by ultrasound) 6) Willing to consent to the study
Exclusion Criteria:
1. Younger than 18 years of age or over 75 years of age
2. Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
3. Depth to the muscle more than 3 cm as assessed with ultrasound.
4. History of fasciotomy performed on the affected leg.
5. Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
6. Language barrier- Inability to read or understand spoken English
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