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临床试验/NCT04264325
NCT04264325已完成不适用

Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture

研究概览

简要总结

Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness.

The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. No predictors exist to identify which patients benefits more of pleural effusion. One study suggests that a inverted hemidiaphramatic (inverted shape) is associated with a greater dyspnea improvement. Others parameters of diaphragmatic motion have not been studied till now.

This study aims to evaluate the feasability of diaphragmatic ultrasound evaluation (shape by B-mode, quiet, deep inspiratory motion and sniff diaphragm motion by TM-mode) before and after pleural drainage.

Primary end point aims to evaluate the feasability of deep breath inspiratory excursion in ipsilateral side of thoracocentesis by anterior subcostal approach in the mid-clavicular line in the right in patients with malignant pleural effusions. The liver or spleen was identified as a window for each hemidiaphragm.

Secondary end points aim to evaluate

  • the feasability of quiet breath inspiratory motion ,
  • the feasability of sniff diaphragm motion
  • the feasability of deep breath inspiratory motion by posterior method
  • the comparaison of feasibility with different types of breathing and or anterior or posterior approach for ultrasound
  • the feasability of the shape by B-mode.
  • the correlation between the change of the shape of ipsilateral diaphragm and the evolution of dyspnea, before and after thoracocentesis.
  • the correlation between the volume of pleural effusion evacuated and the evolution of dyspnea, before and after thoracocentesis.
  • the comparaison of the changing of dyspnea in patients with noticed paradoxal movement of diaphragm before thoracocentesis and patients with persistent paradoxal/or non persistant paradoxal movement of ipsilateral hémidiaphragm.
  • the correlation between the feasability of diaphragmatic ultrasound motion measurments evaluation and the body mass index.
  • the comparaison between the different diaphragmatic ultrsound times for anterior or posterior approach.

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

  • Age> 18 years old
  • Male or female patient
  • Patient with known lung cancer, regardless of histology or suspected of having unknown lung cancer or relapse / progression of lung cancer
  • Presenting a pleural effusion with clinical necessity of evacuating pleural puncture
  • Subject who expressed his non opposition to the research

排除标准

  • Patient's refusal to participate in the study
  • History of pleurodesis whatever the indication (pneumothorax or recurrent pleural effusion) or the technique used
  • Permanent chest drain
  • inability to provide informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
  • Subject under judicial protection
  • Subject under guardianship or curatorship
  • Pregnant or lactating woman

结局指标

主要结局

Evaluate the feasibility of measuring the diaphragmatic amplitude in wide breathing (RA) on the side homolateral to the pleural puncture

时间窗: one day

Rate of patients with a feasible measure of diaphragmatic amplitude in wide breathing (RA), on the side homolateral to the pleural puncture, by the anterior route before and after pleural puncture.

次要结局

  • Feasability of quiet breath inspiratory motion(one day)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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