Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06512870

Can Near Infrared Spectroscopy (NIRS) or Intramuscular Glucose Monitoring Detect Impaired Perfusion in the Anterior Compartment of the Leg in Patients With Tibial Fractures? Proof of Concept Pilot Study

Led by University of Florida · Updated on 2025-06-11

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Near Infrared Spectroscopy (NIRS) and intramuscular glucose monitoring to detect impaired blood flow in the anterior compartment of the leg in patients with tibial fractures complicated by acute compartment syndrome or vascular injury. This study aims to determine if these methods can identify reduced tissue oxygenation and relative hypoglycemia compared to the uninjured leg. Currently, NIRS is not a standard tool for monitoring leg fractures, and this research seeks to provide evidence for its clinical use. Adult patients aged 18 to 75 years with unilateral tibial fractures and acute compartment syndrome or vascular compromise are enrolled. After diagnosis confirmation, NIRS sensors are applied to both legs to measure tissue oxygenation until surgery. During surgery, glucose levels are measured directly from muscle tissue and compared to fingerstick glucose levels. Additional monitoring continues for 72 hours post-surgery if possible. Data collection includes ultrasound measurement of muscle depth, compartment pressure, and demographic and surgical details. Participants will undergo bedside ultrasound and NIRS sensor application, blood glucose testing during surgery, and continuous monitoring before and after surgery. Researchers will collect data on oxygenation changes at multiple time points up to 72 hours post-operation. Safety and privacy are maintained with encrypted data storage and de-identification of patient information. The primary outcomes include detecting perfusion changes with NIRS and documenting intramuscular glucose levels as indicators of tissue ischemia during acute compartment syndrome.

CONDITIONS

Brief Title

Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Diagnosed with tibial fracture or fracture-dislocation complicated by acute compartment syndrome or vascular injury with loss of pulses below the knee
  • Injury affects only one leg (unilateral injury)
  • Depth of anterior compartment of the leg less than 2.5 cm as measured by ultrasound
  • Willing to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Younger than 18 years or older than 75 years
  • Skin damage, open wound, or infection over the anterior compartment of the leg preventing sensor placement
  • Depth to the muscle more than 3 cm as assessed by ultrasound
  • History of fasciotomy surgery on the affected leg
  • Unable to provide informed consent or have a legal guardian or healthcare surrogate consent
  • Inability to read or understand spoken English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for ultrasound measurement and eligibility confirmation

Diagnostic Evaluation

Duration - Hours to days before surgery

Participants undergo pre-scanning of the anterior compartment of the leg and application of near-infrared spectroscopy (NIRS) sensors to measure tissue perfusion before surgery.

1 baseline visit at bedside to apply sensors and obtain initial readings until surgery

Surgery and Immediate Post-operative Care

Duration - Surgery duration plus immediate post-operative period

During surgery, intracompartmental pressure and muscle glucose concentration are measured. After surgery, NIRS sensors are re-applied to the injured leg for continued monitoring.

Surgical procedure and sensor application during and immediately after surgery

Long-term Monitoring

Duration - 72 hours following surgery

Participants are monitored for 72 hours post-surgery with NIRS sensors to assess tissue perfusion in both legs, if the condition permits sensor placement.

Continuous monitoring with sensors; periodic data collection every 6 hours for first 24 hours, then every 12 hours for next 48 hours

Trial Site Locations

Total: 1 location

1

UF Health

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

S

Svetlana Chembrovich, MD

M

Martin S Noguera, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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