Non-invasive Limb Compartment Pressure Measurement

NCT03730688 | Completed

• 2 other identifiers: FNO-TRAUMA-CPMRVO-FNOs/2018
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Compartment Syndromes; Polytrauma; Burn Injury

Keywords

compartment syndrome; compartment pressure; polytrauma; burn injury; limb ischemia; fasciotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Conventional and experimental compartment pressure measurement

EXPERIMENTAL

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; Device: Experimental compartment pressure measurement

Interventions

Conventional compartment pressure measurement DEVICE

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

Conventional and experimental compartment pressure measurement

Experimental compartment pressure measurement DEVICE

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

Conventional and experimental compartment pressure measurement

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• polytrauma
• monotrauma
• burn injury

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (2)

Technical University Ostrava

Ostrava, Moravian-Silesian Region, 70800, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related 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.

  PMID: 27857494 BACKGROUND

• 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.

  PMID: 16891936 BACKGROUND

• 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.

  PMID: 14690292 BACKGROUND

• 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.

  PMID: 25328908 BACKGROUND

MeSH Terms

Conditions

Compartment Syndromes; Multiple Trauma; Burns

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Martin Novák, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Compartment pressure will be measured in a single group of patients, using the conventional and the newly developed experimental means of measurement.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: September 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (2)