跳至主要内容
临床试验/NCT04210102
NCT04210102进行中(未招募)不适用

Accuracy of Lung Ultrasound for the Diagnosis of Community-Acquired Pneumonia in Emergency Room Patients

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
47
试验地点
2
主要终点
The sensitivity of lung ultrasound (LUS) and chest X-ray (CR) to detect community-acquired pneumonia (CAP) will be mesured and compared in patients visiting the emergency department for suspected CAP

研究概览

简要总结

Community-Acquired Pneumonia (CAP) is a major problem in Emergency Department (ED). Diagnosis relies on combination of clinical symptoms and results of chest radiography (CR). Patients' management (treatment, support) depends on delay and quality of the diagnosis. However, signs and symptoms are highly aspecific and interpretation of CR is subject to frequent discrepancies. Then diagnosis of CAP may be uncertain; therefore, overdiagnosis is frequent and leads to over-use of antimicrobial therapy; missing diagnosis is also deleterious and delays adequate treatment including antibiotics. CT scan completes CR and helps clinician making properly diagnosis of CAP; obtaining CT in a 4-hour time-lapse allows better diagnosis and management as accurate as an independent expert adjudication committee does. However availability of CT as well as radiation interrogates on the benefit that Lung Ultrasounds (LUS) may have in diagnosis strategy of suspected CAP. LUS is a noninvasive easy-to-use device whose practice is widely endorsed worldwide by emergency medicine associations and societies. Additionally, previous studies advocate for the use of LUS for diagnosis of CAP in the ED. Therefore the Promotor developed a study to compare LUS and CR as a primary imaging for diagnosis of CAP at the ED.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Adult patients (18+)
  • Suspected CAP by attending emergency physician
  • And new onset of systemic infection (at least one among sweat, chills, aches and pain, temperature ≥38°C or <36°C)
  • And symptoms of an acute lower respiratory tract infection (at least one among cough, sputum production, dyspnea, chest pain, altered breathing sounds at auscultation
  • No previous imaging for the current medical problem
  • Inform consent (signed)
  • Affiliation to insurance (France, Monaco)

排除标准

  • Age below 18-year of age
  • Patients in palliative care
  • Pregnant women
  • anticipated barriers to completing follow-up data collection,
  • patients classified three or higher according to the CRB65 score,
  • patients requiring intensive care for any purpose because of specific management of critically ill
  • refusal to participate to the study

结局指标

主要结局

The sensitivity of lung ultrasound (LUS) and chest X-ray (CR) to detect community-acquired pneumonia (CAP) will be mesured and compared in patients visiting the emergency department for suspected CAP

时间窗: Within the day of inclusion

次要结局

  • specificity, positive predictive value and negative predictive value : indicators of diagnosis performance, will be measured and compared as a primary imaging for diagnosis of CAP(Within the day of inclusion)
  • Specificity, positive predictive value, negative predictive value will be measured and compared in each sequence of imaging (CR + LUS and LUS + CR) for CAP detection(Within the day of inclusion)
  • medical decisions for diagnosis of CAP after each step LUS then CR or CR then LUS and after low dose CT6scan (CT) will be compared to the medical decisions of the adjudication committee(Up to 6 months)
  • The concordance of interpretation (for CR and CT) between attending radiologist and expert radiologist of the adjudication committee (gold standard) wil be studied.(Up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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