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临床试验/NCT04235998
NCT04235998已完成不适用

Value of Additional Upfront Systematic Lung Ultrasound in the Workup of Patients With Unilateral Pleural Effusion: A Prospective Cohort Study

Naestved Hospital1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2020年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion.

研究概览

简要总结

The value of lung ultrasound in the work up of pleural effusion (fluid in between the thin doublet layered film surrounding the lungs) is unknown. The researchers will perform a systematic lung ultrasound scan including a scan for extra thoracic metastasis (spread of cancer to other organs) in the lymphnodes of the neck and metastasis lever in 56 patients one-sided pleural effusion. The researchers will measure if the interventions change the diagnostic plan for the patient and leads to faster diagnostics of the underlying course.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Age ≥ 18 years.
  • Unilateral pleural effusion of unknown course.
  • Patients must be able to give informed consent.

排除标准

  • Bilateral pleural effusions.
  • Known cause of pleural effusions.
  • Life expectancy <3 months.
  • Inability to understand written or spoken Danish.

结局指标

主要结局

Proportion of cases where systematic lung ultrasound (LUS) change the planned diagnostic process for patients with unilateral pleural effusion.

时间窗: 26 weeks post procedure

Information found in electronic patient files. Comparison of diagnostics planned before systematic ultrasound and diagnostics planned after systematic ultrasound. Measured in proportion of included patients

次要结局

  • Proportion of cases where findings of clinical importance on systematic LUS were not identified at the initial contrast-enhanced CT thorax or PET-CT(Day 1 within 30 minutes after the end of procedure)
  • Characteristics of ultrasonic findings with additional systematic LUS.(Day 1, within 30 minutes after the end of procedure)
  • Proportion of cases where the change in the diagnostic process after LUS provide a diagnose(26 weeks post procedure)
  • The patient experienced pain during procedure score(Day 1 within 30 minutes after the end of procedure)
  • The patients willingness to have the same examination again in the future if necessary(Day 1within 30 minutes after the end of procedure)
  • Patient experienced time consumption(Day 1 within 30 minutes after the end of procedure)
  • Mean extra time spend on systematic LUS compared to conventional US for guidance of thoracentesis(Day 1 within 30 minutes after the end of procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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