Non-invasive Limb Compartment Pressure Measurement

NCT ID: NCT03730688

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Compartment Syndromes; Polytrauma; Burn Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Conventional and experimental compartment pressure measurement

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.

Group Type: EXPERIMENTAL

Conventional compartment pressure measurement

Intervention Type: DEVICE

Compartment pressure will be measured using the conventional compartment pressure measurement system.

Experimental compartment pressure measurement

Intervention Type: DEVICE

Compartment pressure will be measured using the newly-developed compartment pressure measurement system.

Interventions

Conventional compartment pressure measurement

Compartment pressure will be measured using the conventional compartment pressure measurement system.

Intervention Type: DEVICE

Experimental compartment pressure measurement

Compartment pressure will be measured using the newly-developed compartment pressure measurement system.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• polytrauma
• monotrauma
• burn injury

Exclusion Criteria

• age below 15 years of age
• skin infection at the area of measurement
• limb-loss trauma

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Novák, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

Technical University Ostrava

Ostrava, Moravian-Silesian Region, Czechia

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 27857494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16891936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14690292 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25328908 (View on PubMed)

Other Identifiers

RVO-FNOs/2018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FNO-TRAUMA-CPM

Identifier Type: -

Identifier Source: org_study_id