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临床试验/NCT05702580
NCT05702580已完成不适用

Pleural Fluid Agitation For Improving The Microbiologic Diagnostic Yield In Pleural Infection - A Comparative Feasibility Study

Alexandria University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月15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
30
试验地点
1
主要终点
Diagnostic yield of the microbiologic analysis

研究概览

简要总结

The goal of this study is to compare the microbiologic diagnostic yield of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The main question it aims to answer is, whether fluid agitation helps to increase the microbiological yield.

详细描述

In pleural infection, It is suggested that the bacteria being diagnostically targeted, might more likely be residing on the pleural surface with a better blood supply and nutrition rather than being planktonic in the acidic, glucose deficient pleural fluid. The investigators thus hypothesize that an agitation of the pleural fluid prior to sample aspiration would aid in achieving a better cellular representation of the pleural space. This could have the effect of washing bacterial cells off the pleural surface as well as moving sedimented cells in the aspirated sample. This study aims to investigate whether an increase in the microbiological yield for infected pleural fluid could be achieved by a pre-aspiration agitation of the pleural fluid which would have a positive effect on management and eventual patient outcomes. Adult participants with pleural infection will undergo thoracentesis via both the standard and agitated fluid techniques guided by thoracic ultrasound. Microbiological yields will be compared.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Laboratory personnel responsible for the microbiological and biochemical analysis will be blinded to the identity of the paired samples.

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
  • Pleural infection based on clinical presentation, imaging or laboratory investigations and pleural fluid examination showing glucose < 40 mg/dL or pH <7.2 with lower respiratory infection or pus on aspiration
  • At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)

排除标准

  • Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
  • Hemodynamic instability
  • Uncorrected coagulopathy
  • Transudative or exudative lymphocytic pleural effusion on biochemical analysis

结局指标

主要结局

Diagnostic yield of the microbiologic analysis

时间窗: results within 1 week of sampling

Percentage of samples with a positive microbiologic result among both aspiration techniques

次要结局

  • Protein level difference between both aspiration methods(results within 1 day of sampling)
  • Neutrophilic count difference between both aspiration methods(results within 1 day of sampling)
  • Glucose level difference between both aspiration methods(results within 1 day of sampling)
  • LDH level difference between both aspiration methods(results within 1 day of sampling)
  • Lymphocytic count difference between both aspiration methods(results within 1 day of sampling)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Salama Sadaka

Doctor

Alexandria University

研究点 (1)

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