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临床试验/NCT04541160
NCT04541160已完成不适用

Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2017年10月1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
237
试验地点
1
主要终点
Community-acquired pneumonia rule-out capability

研究概览

简要总结

This is a randomized study that sought to compare the rule-out capacity and antibiotics prescriptions associated with two different diagnostic imaging strategies (ultra-low-dose chest computed tomography versus chest radiography) in a group of healthy adults presenting to the emergency department (ED) with suspected community-acquired pneumonia (CAP).

详细描述

Between October 2017 and December 2018, we prospectively enrolled consecutive adult patients with suspected community-acquired pneumonia based on at least one respiratory symptom and focal auscultatory findings and at least one sign related to infection, for whom no definitive diagnosis was possible by clinical judgment.

Eligible patients were randomly assigned to their imaging evaluation in a 1:1 ratio to either ultra-low-dose chest computed tomography (ULDCT) or the standard evaluation strategy using conventional chest radiography (CR).

This study sought to compare the rule-out capacity and antibiotics prescriptions associated with those two different diagnostic imaging strategies (ULDCT versus CR) in a group of healthy adult patients presenting to the ED with suspected CAP.

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

  • Suspected CAP;
  • At least one respiratory symptom (new or increasing cough, expectoration, dyspnea or chest pain) and
  • At least one symptom related to infection (fever ≥ 38°C, chills, sweating, myalgia, mental confusion or headache) and
  • Focal auscultatory findings during physical examinations (crackling rales)
  • No definitive diagnosis possible by clinical judgment.

排除标准

  • Score in at least one clinical part of the CURB-65 or PSA scores
  • Clinical diagnosis of rhinosinusitis and acute nasopharyngitis and who had already been treated with antimicrobial therapy for this episode of disease
  • pregnancy;
  • the presence of other respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, chronic diseases or other chronic airway conditions;
  • diagnosis of congestive heart failure;
  • body mass index (BMI) greater than 30;
  • inability to hold the breath for at least 10 seconds

结局指标

主要结局

Community-acquired pneumonia rule-out capability

时间窗: 1 month

Number of Participants for whom ULDCT could diagnose absence of imaging signs of pneumonia

Antibiotics prescription

时间窗: immediate

Number of Participants for whom antibiotics were prescribed to treat bacterial pneumonia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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