Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730688
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2018-11-02
Brief Title:
Non-invasive Limb Compartment Pressure Measurement
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Non-invasive Limb Compartment Pressure Measurement
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FNO-TRAUMA-CPM
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RVO-FNOs2018 | OTHER_GRANT | University Hospital Ostrava | None |