Compartment SyndromesNIRSNCT06512870
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
An observational study of Compartment Syndromes, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compartment Syndromes
- What is being tested?
- Near infrared spectroscopy (NIRS)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to UF Hospital with diagnosis of unilateral tibial fractures, complicated by acute compartment syndrome and/or acute vascular compromise of the fractures leg.
Who may be able to join
- 18 years of age to 75 years of age
- 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
- 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
Who cannot join
- Younger than 18 years of age or over 75 years of age
- Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
- Depth to the muscle more than 3 cm as assessed with ultrasound.
- History of fasciotomy performed on the affected leg.
- Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
- Language barrier- Inability to read or understand spoken English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health
Gainesville, Florida, 32610
Yury Zasimovich, MD, 352-273-8954, YZasimovich@anest.ufl.edu
Svetlana Chembrovich, MD, (352) 273-8954, SChembrovich@anest.ufl.edu
About this study
Official title: Can Near Infrared Spectroscopy (NIRS) or Intramuscular Glucose Monitoring (IMGM) Detect Impaired Perfusion in the Anterior Compartment of the Leg in Patients With Tibial Fractures? "Proof of Concept" Pilot Study
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.
Read the detailed description
Inclusion criteria:
- Patient's age: 18 - 75 years old
- Diagnosis of tibial fracture or fracture-dislocation with diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
- Unilateral injury (i.e. only one leg is affected)
- Depth of anterior compartment of the leg < 2.5 cm (as measured by ultrasound) Study size - 7-10 patients
Procedure of enrollment:
When diagnosis of tibial fracture with vascular compromise or established ACS is made by the ED physician and confirmed by the Orthopedic surgeon, study team will be notified immediately (by the orthopedic service).
Study team member will approach the study candidate, explain the purpose of the study and obtain the informed consent.
After obtaining the consent, pre-scanning of the anterior compartment of the leg will be performed at bedside to measure the depth between the surface of the skin and the muscle.
If depth of the anterior muscular compartment found to be <2.5 cm, NIRS sensors will be applied to the skin of the broken leg at that location, and to the corresponding location on the uninjured leg. Sensors will be connected to the monitor and readings will be obtained until patient enters the OR.
Sensor will be removed from the skin of the injured extremity, but will stay in place on uninjured leg to describe tissue perfusion changed which occur during anesthesia.
When incision is made by the surgeon, upon entering the anterior muscular-fascial compartment, blood sample will be obtained from the cut surface of the muscle for glucose concentration measurement. At the same time fingerstick will be performed and capillary glucose will be measured. Both glucose readings will be recorded.
Before entering the anterior compartment, intracompartmental pressure measurement will be performed by the surgeon using a sterile arterial line catheter attached to the transducer connected to the anesthesia monitor, or with the Striker device - at surgeon discretion.
At completion of the surgery, sensor will be re-applied on the anterior compartment of the injured leg before dressing application.
Monitoring of both extremities will continue for 72 hrs following surgery, (if condition of the operative extremity permits presence of the sensor).
All available data stored in the monitor then will be downloaded and analyzed. (Please see more specific time points below).
Data analysis:
NIRS readings will be collected at the following time=points:
- "time 0" (after sensors' application) - both legs
- "Time in the OR - surgery" - for uninjured leg only - 1 hr after induction of general anesthesia
- "Time in the OR - post surgery", after emergence from anesthesia - both legs
- Every 6 hrs thereafter for the first 24 hrs,
- Every 12 hrs for subsequent 48 hrs. Graphic analysis: Superimposed graphs (trajectories) of all patients in each group (with vascular injury and without vascular injury).
Means will be calculated for the injured and uninjured leg for all time points as mentioned above.
Graphs for means will be also created and analyzed. Additionally, the following data will be collected: demographic data ( patient's age, gender), fracture diagnosis, time from admission to surgery, type of surgery performed (external temporary fixation, internal fixation with intramedullary nail vs with plate(s)).
Data will be downloaded to the encrypted thumb-drive and transferred to a password-protected electronic file on HSC server. Only HRRC-approved investigators will have access to the files.
After completion of the study all electronic data will be destroyed. Temporary data sheets will be used to facilitate data collection. They will be stored in the locked cabinet in the Anesthesiology department offices, away from patient areas.
Upon enrollment patients will be given numbers from 1 to 10. After complete set of data is obtained, each patient will be de-identified. Should need arise to refer back to the electronic data, patients will be only identified by their numbers (from 1 to 10) and their respective sets of data.
- Conditions
- Compartment Syndromes
- Being tested
- Near infrared spectroscopy (NIRS)
- Keywords
- ACS (Acute compartment syndrome), NIRS (near infrared spectroscopy), IM (intramuscular) glucose
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy (NIRS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Known ACS | Patients, aged 18 to 75 years, with diagnosis of unilateral tibial fracture, complicated by Acute Compartment syndrome and/or acute vascular compromise (leg ischemia, absent pulses below the knee), as diagnosed and confirmed by ED physician, orthopedic surgeon and/or vascular surgeon. Only patients with depth to anterior compartment <2.5 cm as measured by the ultrasound will be enrolled. Receives: Diagnostic Test: Near infrared spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: once, intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Mar 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment SyndromesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512870
- Sponsor's protocol ID
- IRB202400236
- Acronym
- NIRS
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Near Infrared Spectroscopy (NIRS) or Intramuscular Glucose Monitoring (IMGM) Detect Impaired Perfusion in the Anterior Compartment of the Leg in Patients With Tibial Fractures? "Proof of Concept" Pilot Study
- ClinicalTrials.gov ID
- NCT06512870
- Acronym / sponsor ID
- NIRS / IRB202400236
- Conditions
- Compartment Syndromes
- Keywords
- ACS (Acute compartment syndrome), NIRS (near infrared spectroscopy), IM (intramuscular) glucose
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion criteria:
- Patient's age: 18 - 75 years old
- Diagnosis of tibial fracture or fracture-dislocation with diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
- Unilateral injury (i.e. only one leg is affected)
- Depth of anterior compartment of the leg < 2.5 cm (as measured by ultrasound) Study size - 7-10 patients
Procedure of enrollment:
When diagnosis of tibial fracture with vascular compromise or established ACS is made by the ED physician and confirmed by the Orthopedic surgeon, study team will be notified immediately (by the orthopedic service).
Study team member will approach the study candidate, explain the purpose of the study and obtain the informed consent.
After obtaining the consent, pre-scanning of the anterior compartment of the leg will be performed at bedside to measure the depth between the surface of the skin and the muscle.
If depth of the anterior muscular compartment found to be <2.5 cm, NIRS sensors will be applied to the skin of the broken leg at that location, and to the corresponding location on the uninjured leg. Sensors will be connected to the monitor and readings will be obtained until patient enters the OR.
Sensor will be removed from the skin of the injured extremity, but will stay in place on uninjured leg to describe tissue perfusion changed which occur during anesthesia.
When incision is made by the surgeon, upon entering the anterior muscular-fascial compartment, blood sample will be obtained from the cut surface of the muscle for glucose concentration measurement. At the same time fingerstick will be performed and capillary glucose will be measured. Both glucose readings will be recorded.
Before entering the anterior compartment, intracompartmental pressure measurement will be performed by the surgeon using a sterile arterial line catheter attached to the transducer connected to the anesthesia monitor, or with the Striker device - at surgeon discretion.
At completion of the surgery, sensor will be re-applied on the anterior compartment of the injured leg before dressing application.
Monitoring of both extremities will continue for 72 hrs following surgery, (if condition of the operative extremity permits presence of the sensor).
All available data stored in the monitor then will be downloaded and analyzed. (Please see more specific time points below).
Data analysis:
NIRS readings will be collected at the following time=points:
- "time 0" (after sensors' application) - both legs
- "Time in the OR - surgery" - for uninjured leg only - 1 hr after induction of general anesthesia
- "Time in the OR - post surgery", after emergence from anesthesia - both legs
- Every 6 hrs thereafter for the first 24 hrs,
- Every 12 hrs for subsequent 48 hrs. Graphic analysis: Superimposed graphs (trajectories) of all patients in each group (with vascular injury and without vascular injury).
Means will be calculated for the injured and uninjured leg for all time points as mentioned above.
Graphs for means will be also created and analyzed. Additionally, the following data will be collected: demographic data ( patient's age, gender), fracture diagnosis, time from admission to surgery, type of surgery performed (external temporary fixation, internal fixation with intramedullary nail vs with plate(s)).
Data will be downloaded to the encrypted thumb-drive and transferred to a password-protected electronic file on HSC server. Only HRRC-approved investigators will have access to the files.
After completion of the study all electronic data will be destroyed. Temporary data sheets will be used to facilitate data collection. They will be stored in the locked cabinet in the Anesthesiology department offices, away from patient areas.
Upon enrollment patients will be given numbers from 1 to 10. After complete set of data is obtained, each patient will be de-identified. Should need arise to refer back to the electronic data, patients will be only identified by their numbers (from 1 to 10) and their respective sets of data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Known ACS | – | Diagnostic Test: Near infrared spectroscopy (NIRS)Patients, aged 18 to 75 years, with diagnosis of unilateral tibial fracture, complicated by Acute Compartment syndrome and/or acute vascular compromise (leg ischemia, absent pulses below the knee), as diagnosed and confirmed by ED physician, orthopedic surgeon and/or vascular surgeon. Only patients with depth to anterior compartment <2.5 cm as measured by the ultrasound will be enrolled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to UF Hospital with diagnosis of unilateral tibial fractures, complicated by acute compartment syndrome and/or acute vascular compromise of the fractures leg.
Key inclusion criteria (4 listed)
- 18 years of age to 75 years of age
- 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
- 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
Key exclusion criteria (6 listed)
- Younger than 18 years of age or over 75 years of age
- Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
- Depth to the muscle more than 3 cm as assessed with ultrasound.
- History of fasciotomy performed on the affected leg.
- Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Known ACS |
Primary outcome
Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise.
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compartment Syndromes, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Chembrovich, MD (443-760-1481, schembrovich@anest.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise. (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.