Non-invasive Limb Compartment Pressure Measurement

Study Overview
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Brief Summary
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Compartment syndrome (CS) is a serious complication of soft-tissue injuries in patients with fractures of the musculoskeletal apparatus. CS is defined as a condition, during which an increased tissue pressure inside an enclosed compartment damages the microcirculation and neuromuscular function of the tissue, and results in ischemization, with a damage of nerve-muscle structures, which lead either to extensive flexion contractures, or myonecroses, with the need to perform an early amputation of the affected limb. In traumatology, compartment syndrome is most frequently observed in a patient with crural fractures, closed as well as open fractures, or in cases of crus laceration.

Detailed Description
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Compartment syndrome (CS) is a serious complication of soft-tissue injuries in patients with fractures of the musculoskeletal apparatus. CS is defined as a condition, during which an increased tissue pressure inside an enclosed compartment damages the microcirculation and neuromuscular function of the tissue, and results in ischemization, with a damage of nerve-muscle structures, which lead either to extensive flexion contractures, or myonecroses, with the need to perform an early amputation of the affected limb. In traumatology, compartment syndrome is most frequently observed in patients with crural fractures, closed as well as open fractures, or in cases of crus laceration. Diagnostics of the compartment syndrome is very difficult, even today, when numerous emergency osteosyntheses are performed, as it depends not only on the clinical examination of the injured patient but also upon subjective symptoms, which may not be always clearly apparent and objectively quantifiable in a disoriented patient with concussion, or in an unconscious patient. At present, intracompartmental pressure is measured with invasive techniques only (with the insertion of the measurement needle into the compartment space, and administration of saline), or invasively, using piezoelectric probes, similarly to a measurement of pressure in vessels. Both these techniques are invasive, and as such may be associated with complications (infection at the puncture site, increase of intracompartmental pressure with administration of the measuring liquid, or formation of haematoma and bleeding at the probe site). Physiological values of intracompartmental pressure vary between 5 and 10 mmHg, in case an increase over 20 mmHg is observed, emergency dermatofasciotomy is indicated. The presented project is aimed at comparing the invasive and non-invasive techniques of compartment syndrome measurement. The aim of the project is to develop a new non-invasive examination technique of intracompartmental pressure measurement in soft tissues of the injured extremity, with the possibility of its observation and continuous monitoring of the measured values. Partial aims Invasive measurement of limb intracompartmental pressure. Development of a new examination technique for non-invasive measurement of the compartment syndrome, in cooperation with researchers from the Technical University Ostrava Measurement of compartment syndrome using the new non-invasive examination technique and monitoring of data Methods First of all, compartmental pressures in the limbs will be performed using the invasive technique. The measurement will be performed also in cases when a fasciotomy was indicated and performed, and the authors will monitor the decrease of compartmental pressure in the course of treatment. Individual measurements will be recorded and statistically analyzed. In the course of measurement, the researchers will work upon the development of a new non-invasive examination technique, which will be intended for non-invasive measurement of compartmental pressure. The research team will also compare both these techniques, and assess the advantages and disadvantages of each of the techniques used. Statistical data processing Results of measurements of compartmental pressure using individual techniques will be statistically evaluated, depending on the clinical findings at the injured extremity.

Official Title
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Non-invasive Limb Compartment Pressure Measurement

Conditions
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Compartment Syndromes, Polytrauma, Burn Injury

Intervention / Treatment
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* Device: Conventional compartment pressure measurement
* Device: Experimental compartment pressure measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: polytrauma monotrauma burn injury Exclusion Criteria: age below 15 years of age skin infection at the area of measurement limb-loss trauma

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Compartment pressure will be measured in a single group of patients, using the conventional and the newly developed experimental means of measurement.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional and experimental compartment pressure measurement<br>Compartment pressure in the patients in this group will be measured using the conventional Intra-Compartmental Pressure Monitor System (Stryker) and using the newly-developed measuring device. | Device: Conventional compartment pressure measurement<br>* Compartment pressure will be measured using the conventional compartment pressure measurement system.<br>Device: Experimental compartment pressure measurement<br>* Compartment pressure will be measured using the newly-developed compartment pressure measurement system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 30% decrease of complications related to compartment pressure measurement | The number of complications related to compartment pressure measurement will be observed for both interventions, with the target of achieving a 30% decrease. | 37 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compartment syndrome, compartment pressure, polytrauma, burn injury, limb ischemia, fasciotomy