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临床试验/NCT04217980
NCT04217980已完成不适用

Analysis of a Diagnostic Algorithm of Severe Pneumonia in Pediatric Critical Patients by Pulmonary Ultrasound and Procalcitonin as a Plan to Improve the Quality of Care

Fundació Sant Joan de Déu2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2017年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
2
主要终点
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis

研究概览

简要总结

Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. The investigators propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest radiograph (CXR).

详细描述

Objectives: The general objective is to analyze whether a new algorithm approach of severe pneumonia in pediatric intensive unit (PICU) improves the quality of care. Objectives: 1- To analyze the sensitivity and specificity of lung ultrasound (LUS) compared respect to the chest radiography (CXR) in severe pneumonia and if LUS discriminates between bacterial and viral one. 2- If there is a lower CXR indication. 3- If is possible to reduce the dose of irradiation and costs associated with CXR. 4- To analyze the interobserver agreement of the LUS. 5- determine whether a diagnosis of pneumonia algorithm using LUS and procalcitonin may be useful in directing the indication of antibiotic therapy and / or the duration thereof.

Methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year trial. Inclusion of children under 18 years, with severe pneumonia, who enter (PICU). Experimental Group 1: pediatrician researcher (PR) will conduct a LUS at admission time, as a first test of lung image; in Group 2, CXR is conduced as first image. Patients will be classified into 3 subgroups, in both branches: a) if PCT is <1 ng /L and LUS is not suggestive of bacterial pneumonia, no antibiotic will be prescribed; b) if LUS is suggestive of bacterial pneumonia, regardless of the PCT, it will be recommended to start antibiotic therapy; c) If the ultrasound is suggestive of bacterial pneumonia but PCT is> 1 ng / L, antibiotic therapy will be recommended to cover other causes of infection. The same attitude will be performed, but depending on the CXR instead of the LUS, in group 2. Clinical variables, complementary tests and evolution data will be collected. Statistics by SPPS® 20.0. Informed consent will be requested and the study will be conducted according to the Helsinki Declaration guidelines and Good Clinical Practice.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •children under 18
  • •severe pneumonia criteria
  • •admitted at PICU
  • •informed consent signed

排除标准

  • •previous respiratory disease (cystic fibrosis and/or immunosuppression)
  • •Nosocomial pneumonia development while in charge for community pneumonia.
  • •Researcher pediatrician has valuated the chest X ray before the PICU admission
  • •Included in other clinical trial

研究组 & 干预措施

Lung ultrasonography (LUS) group

Experimental

Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test

干预措施: Lung ultrasonography (LUS) or Chest X ray (CXR) (Diagnostic Test)

Chest X ray (CXR) group

Active Comparator

Group 2: Chest X ray is performed as main (first) pulmonary image test

干预措施: Lung ultrasonography (LUS) or Chest X ray (CXR) (Diagnostic Test)

结局指标

主要结局

Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis

时间窗: through study completion, an average of 2 years

Sens and Spe for LUS group and for X-Ray group

次要结局

  • antibiotic days of treatment(through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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