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临床试验/NCT03924583
NCT03924583Unknown不适用

Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse

Masaryk Hospital Krajská zdravotní a.s.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Incidence of catheter related thrombosis - physician and nurse

研究概览

简要总结

Catheter-related thrombosis (CRT) has been found as the major complication of the established central venous catheter in intensive care unit (ICU) patients. Its reported incidence varies from 5 to 66 %. Although most cases are asymptomatic, in up to 10 - 15 % of the patients pulmonary embolism occurs. In addition, CRT is associated with the risk of infection, post-thrombotic syndrome and with general disruption of the management of the underlying disease. The most accessible diagnostic method for CRT recognition is duplex ultrasonography. However, screening of CRT by duplex ultrasonography is not common approach in ICUs. Normally, duplex ultrasonography is performed by physicians. In this setting, implementation of the screening in ICU would be time consuming and practically unrealizable. Delegating this competence to ICU nurses can increase availability of this screening method.

Therefore, as a first step, investigators decided to perform a validation clinical study to verify the diagnostic accuracy of duplex ultrasonography of the venous system for CRT screening performed by a general nurse.

详细描述

Approximately 150 patients with central venous catheter will be enrolled in this study.

Investigators:

  1. General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
  2. Doctors - experienced specialists in intensive care or urgent medicine

Every patient with central venous catheter enrolled in clinical study is examined with duplex ultrasonography within 24 hours by both investigators, doctor and nurse. Each examination includes ultrasonography of a whole vena cava venous system with central venous catheter, bilaterally. Results of both examinations are blinded until the end of study, with one exception. In case of positive result - catheter related thrombosis is present, investigator ( nurse )informs patients attending physician.

Results of investigations are recorded in Investigation Form with some other routine medical data.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • central venous catheter more than 48 hours in situ
  • consent of a patient

排除标准

  • technical difficulties of ultrasound machine
  • unfavorable local findings - inflammation of skin, excoriation etc.

结局指标

主要结局

Incidence of catheter related thrombosis - physician and nurse

时间窗: 24hours

Diagnostic reliability of duplex ultrasonography examination of the venous system for screening of catheter-related thrombosis performed by a general nurse

次要结局

未报告次要终点

研究者

发起方
Masaryk Hospital Krajská zdravotní a.s.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbora Pakostová, M.D.

Medical doctor

Masaryk Hospital Krajská zdravotní a.s.

研究点 (1)

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