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临床试验/NCT04806555
NCT04806555Unknown不适用

Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation

Kantonsspital Aarau2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
38
试验地点
2
主要终点
Elasticity ratio (ER)

研究概览

简要总结

Acute compartment syndrome (ACS) after revascularization for acute limb ischemia is a potentially limb-threatening condition and requires urgent fasciotomy. Compression ultrasound (CU) is an established method for measuring intravenous pressure in superficial veins and, for example, can determine central venous pressure in critically ill patients. In cadaver studies, compression ultrasound has been proven to correlate with invasive intra compartmental pressure (ICP) measurements. This study aims to determine CU's added diagnostic value compared to ICP in detecting ACS after revascularisation.

详细描述

Acute compartment syndrome (ACS) after revascularization for acute limb ischemia is a potentially limb-threatening condition and requires urgent fasciotomy. It occurs when the tissue pressure within a closed muscle compartment exceeds the perfusion pressure and results in muscle and nerve ischemia.

If clinically suspected, intra- compartmental pressure (ICP) is measured by inserting a needle into the area of ACS, usually the anterior tibial muscle compartment, while an attached pressure monitor records the pressure. This invasive diagnostic method is widely used as a standard with a sensitivity of 94% and specificity of 98%.

Compression ultrasound (CU) is an established method for measuring intravenous pressure in superficial veins and, for example, can determine central venous pressure in critically ill patients. An ultrasound translucent probe measures the pressure applied on the skin surface with the ultrasound transducer. In cadaver studies, compression ultrasound has been proven to correlate with invasive ICP measurements. The elasticity ratio (ER, compartment diameter with and without external pressure) validated in a recently published animal model has a sensitivity of 94.4% and a specificity of 88.9% to diagnose a compartment syndrome properly. The first results in six trauma patients showed that the ER less than 10,5% of the anterior tibial compartment had a sensitivity of 95,8% and a specificity of 87,5% to an appropriate diagnosis of ACS. Thus, this non-invasive, low-cost, and secure diagnostic technique has not been validated in patients with ACS after revascularisation for acute lower limb ischemia yet has the potential to discriminate clinically suspected ACS sensitively.

This study aims to determine CU's added diagnostic value compared to ICP in detecting ACS after revascularisation.

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

入排标准

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

入选标准

  • Clinical suspicion of acute compartment syndrome after revascularisation of lower limb

排除标准

  • Not fulfilling any of the inclusion criteria
  • Patients refusing to participate

结局指标

主要结局

Elasticity ratio (ER)

时间窗: baseline

Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure

次要结局

  • Inter- and intra-rater reliability(baseline)

研究者

发起方
Kantonsspital Aarau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrej Isaak

Head of Vascular Surgery

Kantonsspital Aarau

研究点 (2)

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