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Non-invasive Limb Compartment Pressure Measurement (FNO-TRAUMA-CPM)

Primary Purpose

Compartment Syndromes, Polytrauma, Burn Injury

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Conventional compartment pressure measurement
Experimental compartment pressure measurement
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Compartment Syndromes focused on measuring compartment syndrome, compartment pressure, polytrauma, burn injury, limb ischemia, fasciotomy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • polytrauma
  • monotrauma
  • burn injury

Exclusion Criteria:

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

Sites / Locations

  • Technical University Ostrava
  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional and experimental compartment pressure measurement

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2018
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT03730688
Brief Title
Non-invasive Limb Compartment Pressure Measurement
Acronym
FNO-TRAUMA-CPM
Official Title
Non-invasive Limb Compartment Pressure Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndromes, Polytrauma, Burn Injury
Keywords
compartment syndrome, compartment pressure, polytrauma, burn injury, limb ischemia, fasciotomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
No masking will be used in the study.
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional and experimental compartment pressure measurement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional compartment pressure measurement
Intervention Description
Compartment pressure will be measured using the conventional compartment pressure measurement system.
Intervention Type
Device
Intervention Name(s)
Experimental compartment pressure measurement
Intervention Description
Compartment pressure will be measured using the newly-developed compartment pressure measurement system.
Primary Outcome Measure Information:
Title
A 30% decrease of complications related to compartment pressure measurement
Description
The number of complications related to compartment pressure measurement will be observed for both interventions, with the target of achieving a 30% decrease.
Time Frame
37 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Novák, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technical University Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70800
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study team have not decided to make individual participant data available to other researchers.
Citations:
PubMed Identifier
27857494
Citation
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.
Results Reference
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PubMed Identifier
16891936
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.
Results Reference
background
PubMed Identifier
14690292
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.
Results Reference
background
PubMed Identifier
25328908
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.
Results Reference
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Non-invasive Limb Compartment Pressure Measurement

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