跳至主要内容
临床试验/NCT04483193
NCT04483193Unknown不适用

Reliability of Extended Duplex Ultrasound for Diagnosis of Proximal Deep Vein Thrombosis Performed by General Intensive Care Unit Nurses in the Critically Ill Patients

Emergency Medical Service of the Central Bohemian Region, Czech Republic1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年7月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Validity of duplex ultrasound

研究概览

简要总结

The purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients.

详细描述

Critically ill patients hospitalized in the intensive care unit are in increased risk of proximal deep vein thrombosis despite thromboprophylactic measures. Diagnostic method of the first choice is Point-of-Care ultrasound examination. This method is usually performed by a trained intensive care physician. However, if this examination could be performed by trained nurses, its availability would be greatly increased. The results of the investigator's pilot study showed that general nurses are able to diagnose proximal deep vein thrombosis in critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a specificity of 99 %. Before implementation of this examination into the optional competencies of general nurses, the results need to be confirmed in a larger group of patients. This is the goal of proposed clinical study.

In this prospective observational study, the patients will be investigated by extended duplex ultrasound (compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region) by a trained nurse and on the same day, the examination will be repeated by a trained physician - intensivist. The results of the examinations of each patient will be blinded until both tests will be performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Inpatients
  • Critically ill patients hospitalised in the intensive care unit for more than 72 hours

排除标准

  • Known deep vein thrombosis
  • Contraindication of ultrasound examination
  • Refusal of ultrasound examination by patient

结局指标

主要结局

Validity of duplex ultrasound

时间窗: Comparison of two examinations performed with a maximum interval of 24 hours.

Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.

次要结局

未报告次要终点

研究者

发起方
Emergency Medical Service of the Central Bohemian Region, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roman Skulec

Principal investigator

Masaryk Hospital Usti nad Labem

研究点 (1)

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