跳至主要内容
临床试验/NCT05550038
NCT05550038招募中不适用

Diagnostic Performance of General Practitioners in Compression Ultrasound for the Diagnosis of Proximal Deep Vein Thrombosis of the Lower Limbs

University Hospital, Caen38 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
38
主要终点
Diagnostic performance of 3 point venous compression

研究概览

简要总结

The objective of this study is to evaluate the diagnostic efficiency of general practitioners for the diagnosis of proximal deep vein thrombosis of the lower limbs compared with whole-leg ultrasound with Doppler performed by the vascular physician.

详细描述

After being informed about the study and the potential risks, all patients who have given their written consent and who meet the eligibility criteria will benefit from a 3-point compression ultrasound performed by the general practitioner before being referred for a whole-leg ultrasound with Doppler at the vascular physician.

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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years
  • Management by a general practitioner trained in 3-point venous ultrasound
  • Suspicion of deep vein thrombosis by the general practitioner with prescription of a whole-leg Doppler ultrasound by a vascular physician. It is noted that the patient can be included from the moment the general practitioner had planned to refer the patient to the vascular physician for a suspicion of DVT, including in the absence of realization of DDimer on a low probability of DVT. It may also be included in case of positive DDimer tests.
  • Signed written consent
  • Patient covered by the French social security system

排除标准

  • Whole leg ultrasound performed more than 72 hours after the initial examination
  • History of homolateral deep vein thrombosis
  • Patient objecting to the use of his data
  • Refusal of written and signed consent

结局指标

主要结局

Diagnostic performance of 3 point venous compression

时间窗: 72 hours

The diagnostic performance (Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value) of 3-point venous compression ultrasound performed by general practitioners for the diagnosis of proximal venous thrombosis of the lower limbs compared to the usual recommended examination (whole leg ultrasound by a vascular physician)

次要结局

  • The evaluation of the feasibility of venous compression ultrasound in the office by the general practitioner.(72 hours)
  • Duration of the ultrasound performed by the general practitioner in minutes.(72 hours)
  • The interpretability of ultrasound images by general practitioners(72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (38)

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