Non-invasive Limb Compartment Pressure Measurement

Burn Injury Clinical Trial

— FNO-TRAUMA-CPM  

Official title:

Non-invasive Limb Compartment Pressure Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730688
• Other study ID #: FNO-TRAUMA-CPM
• Secondary ID: RVO-FNOs/2018
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. Invasive measurement of limb intracompartmental pressure.

2. Development of a new examination technique for non-invasive measurement of the compartment syndrome, in cooperation with researchers from the Technical University Ostrava

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• polytrauma

• monotrauma

• burn injury

Exclusion Criteria:

• age below 15 years of age

• skin infection at the area of measurement

• limb-loss trauma

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Compartment Syndromes
• Multiple Trauma
• Polytrauma

Intervention

Device:
• Conventional compartment pressure measurement
Compartment pressure will be measured using the conventional compartment pressure measurement system.
• Experimental compartment pressure measurement
Compartment pressure will be measured using the newly-developed compartment pressure measurement system.

Locations

Country	Name	City	State
Czechia	Technical University Ostrava	Ostrava	Moravian-Silesian Region
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

Beniwal RK, Bansal A. Osteofascial compartment pressure measurement in closed limb injuries - Whitesides' technique revisited. J Clin Orthop Trauma. 2016 Oct-Dec;7(4):225-228. doi: 10.1016/j.jcot.2016.01.001. Epub 2016 Feb 10. — View Citation

Dickson KF, Sullivan MJ, Steinberg B, Myers L, Anderson ER 3rd, Harris M. Noninvasive measurement of compartment syndrome. Orthopedics. 2003 Dec;26(12):1215-8. doi: 10.3928/0147-7447-20031201-11. — View Citation

Lee SH, Padilla M, Lynch JE, Hargens AR. Noninvasive Measurements of Pressure for Detecting Compartment Syndromes. J Orthop Rheumatol. 2013 Dec 21;1(1):5. — View Citation

Wiemann JM, Ueno T, Leek BT, Yost WT, Schwartz AK, Hargens AR. Noninvasive measurements of intramuscular pressure using pulsed phase-locked loop ultrasound for detecting compartment syndromes: a preliminary report. J Orthop Trauma. 2006 Jul;20(7):458-63. doi: 10.1097/00005131-200608000-00002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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