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临床试验/CTRI/2023/01/049101
CTRI/2023/01/049101尚未招募不适用

Role of ultrasound in qualitative and quantitative assessment of pleural effusion - a diagnostic analytic study

Max Super Speciality Hospital, Shalimar Bagh, New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Primary: 1. To differentiate transudative and exudative pleural effusion on lung USG based on the presence of a combination of factors including echogenicity, pleural thickening and septations, as compared to pleural fluid analyzed using Light’s criteria.

研究概览

简要总结

This study aims to evaluate the diagnostic utility of ultrasonography in differentiating exudative from transudative pleural effusion and estimating its volume. The study will enrol a total of 100 subjects over 15-18 months period attending Departments of Medicine/ICU/Radio-Diagnosis in a Corporate hospital, and having pleural effusion diagnosed on USG. To differentiate transudative and  exudative pleural effusion, lung USG will evaluate accuracy of presence of a combination of factors including echogenicity, septations and pleural thickening, as compared to pleural fluid analysed using Light’s criteria. Estimation of volume of pleural effusion on lung USG will use the Balik’s Formula (supine position)/Goecke Formula (erect position) as compared to CT chest volumetry. The diagnostic accuracy of various ultrasonographical features being used to distinguish between exudative and transudative pleural effusion will be calculated. Diagnosis of exudate/ transudate and volumetry on USG will help clinician assess the effusion as a whole without the need for invasive investigations like thoracocentesis. Faster diagnosis provided by USG will help make prompt therapeutic decisions and early institution of treatment. Further, in effusions whose nature is clear on ultrasonography and which do not cause distress to the patient, thoracocentesis can be avoided. However, in patients with respiratory distress and large volumes of effusion, therapeutic thoracocentesis would still be required.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients who are above 18 years of age having pleural effusion on lung USG.
  • All patients whose CT Chest done within 24 hours of the ultrasound.
  • 3.All patients whose pleural fluid biochemical analysis done post thoracocentesis.

排除标准

  • Pregnancy
  • Hemodynamically unstable patients
  • Patients not able to obey breathing instructions
  • Patients on mechanical ventilation
  • Patients with history of trauma
  • Subcutaneous emphysema over the chest.

结局指标

主要结局

Primary: 1. To differentiate transudative and exudative pleural effusion on lung USG based on the presence of a combination of factors including echogenicity, pleural thickening and septations, as compared to pleural fluid analyzed using Light’s criteria.

时间窗: 24 hours

2. Estimation of volume of pleural effusion on lung USG using the Balik’s Formula (supine)/Goecke Formula (erect) as compared to CT chest volumetry.

时间窗: 24 hours

次要结局

  • 1. To calculate the diagnostic accuracy of pleural internal echoes, thickening and septations in classifying pleural effusion as exudate.(24 hours)

研究者

发起方
Max Super Speciality Hospital, Shalimar Bagh, New Delhi
申办方类型
Private hospital/clinic

研究点 (1)

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