Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse
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:
- General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
- 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
- 否
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
Barbora Pakostová, M.D.
Medical doctor
Masaryk Hospital Krajská zdravotní a.s.
