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临床试验/NCT03411824
NCT03411824已完成不适用

Lung Ultrasound for Community-acquired Pneumonia Diagnosis in Emergency Medicine

Nantes University Hospital4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年11月8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
90
试验地点
4
主要终点
Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization

研究概览

简要总结

Community-acquired pneumonia (CAP) is frequently suspected in the Emergency Department (ED). However, usual diagnosis procedure based on clinical features and chest X-Ray has rather bad performances.

A recent study on CT performance in suspected CAP found that 58% of classifications were modified by CT when compared with usual procedure. However, extended CT usage in CAP diagnosis is associated with many limitations :

availability in a majority of ED, delay, cost and irradiation, in particular In young patients.

Lung Ultrasound (LUS) has good performances in CAP diagnosis even when compared with CT. It is a rapid, inexpensive, radiation-free tool available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training.

The Investigators aim to investigate LUS performances in clinically suspected CAP authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .

详细描述

120 patients will be enrolled on CAP suspicion. All explorations (radiography...) and biological exams (blood culture...) will be performed as usual to build physician primary diagnosis. Complementarily, an EP will be realized and final diagnosis will be made by physician. Finally, at Day28 expert adjudication committee will authentic diagnosis considering explorations and clinical issues. Frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured Primary Purpose: diagnostic Study Phase: Not Applicable Intervention Model: NA Number of Arms: 1 Masking: open label, Masked Roles: NA Allocation: NA Study Endpoint Classification: efficacy Enrollment: 120 subjects (anticipated )

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Frequency of PAC classification modification (definite, probable, possible, excluded) after LUS realization

时间窗: Day 0

95% confidence interval of CAP classification modification frequency before and after LUS realization

次要结局

  • Concordancy of CAP classification diagnosis concordancy ( after LUS) compared to adjudication committee(28 days after enrollment)
  • Frequency of Antibiotic prescription modification after LUS(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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