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临床试验/NCT03730688
NCT03730688已完成不适用

Non-invasive Limb Compartment Pressure Measurement

University Hospital Ostrava4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
4
主要终点
A 30% decrease of complications related to compartment pressure measurement

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

No masking will be used in the study.

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • polytrauma
  • monotrauma
  • burn injury

排除标准

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

结局指标

主要结局

A 30% decrease of complications related to compartment pressure measurement

时间窗: 37 months

The number of complications related to compartment pressure measurement will be observed for both interventions, with the target of achieving a 30% decrease.

次要结局

未报告次要终点

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (4)

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