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临床试验/NCT03630380
NCT03630380Unknown不适用

Accuracy of History, Physical Exam, Laboratory Findings and Lung Ultrasound Compared to Chest Radiograph for the Diagnosis of Pneumonia in Pediatric Patients Presenting to Patan Hospital in Nepal

Patan Academy of Health Sciences1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

Pneumonia continues to be a leading cause of death in children under five years of age worldwide. Many studies have evaluated clinical signs and symptoms that may predict pneumonia. A recent meta-analysis found that no singular physical exam finding predicted pneumonia. The World Health Organization (WHO) Criteria diagnose pneumonia based on fast breathing; however, tachypnea has not been shown to strongly predict pneumonia. This study will evaluate accuracy of clinical history, physical exam and WHO criteria, laboratory findings, and lung ultrasound compared with chest radiograph for the diagnosis of pneumonia in children under five years of age in a resource limited setting. Determining diagnostic accuracy of these findings may help derive a clinical decision rule that may more accurately predict which children have pneumonia than current WHO guidelines.

详细描述

Background Pneumonia is the leading cause of death in children under five years of age worldwide.1 These deaths may be prevented by early detection and targeted antibiotic therapy.2 However, the diagnosis is not always clear on presentation to health care facilities. Missed diagnosis may lead to increased morbidity and mortality, while over-diagnosis may lead to unnecessary antibiotic use, which may further lead to increased antibiotic resistance, cause allergic reactions, and create unnecessary costs for patients. Therefore, using clinical tools and diagnostic capabilities to better improve diagnosis is critical.

Many studies have evaluated clinical signs and symptoms that may predict pneumonia.3-6 A recent meta-analysis found that no singular physical exam finding predicted pneumonia.5 The World Health Organization (WHO) Criteria diagnose pneumonia based on fast breathing; however, tachypnea has not been shown to strongly predict pneumonia.7 Additionally, most children with fever have compensatory tachypnea as a result, making the criteria of fast breathing difficult to diagnose pneumonia alone.8 In Nepal, one study evaluating the WHO criteria for pneumonia found a sensitivity of only 69.6% and specificity of 59.6%.9 Despite this, many providers rely on clinical exam findings and the WHO criteria for diagnosing pneumonia.

When available, diagnostic imaging is used regularly to confirm suspected pneumonia. Chest x-ray has been the standard for diagnosis in most facilities worldwide. However, remote facilities in resource-limited settings often lack radiographic imaging capabilities. Many facilities have bedside ultrasound available as it is easily portable, repeatable, and not associated with radiation. Ultrasound has been shown to be sensitive and specific for the diagnosis of pneumonia, yet few studies have evaluated the accuracy of lung ultrasound for pneumonia in pediatric patients in a resource-limited setting.10-14

The objective of this study is to evaluate the diagnostic accuracy of clinical history, physical exam, laboratory findings, and lung ultrasound compared to chest x-ray for the diagnosis of pneumonia in pediatric patients in a resource-limited setting. Determining diagnostic accuracy of these findings may help derive a clinical decision rule that may more accurately predict which children have pneumonia than current WHO guidelines.

Study Design

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients presenting under age 5 years
  • Presence of fever, respiratory complaints, or concern for pneumonia
  • Receiving chest x-ray imaging

排除标准

  • Children not receiving chest x-ray imaging as part of their workup for possible pneumonia
  • Patients 5 years of age and older

结局指标

主要结局

Sensitivity

时间窗: 1 day

We will follow patients during their acute visit to evaluate accuracy of clinical history, physical exam findings (including WHO criteria for diagnosing pneumonia), laboratory findings, and lung ultrasound using chest radiographs as the standard for diagnosing pneumonia. We will determine the sensitivity and specificity, and area under the receiver operator curve and determine if there are better combination of clinical and diagnostic predictors for diagnosis of pneumonia in children.

Specificity

时间窗: 1 day

We will follow patients during their acute visit to evaluate accuracy of clinical history, physical exam findings (including WHO criteria for diagnosing pneumonia), laboratory findings, and lung ultrasound using chest radiographs as the standard for diagnosing pneumonia. We will determine the sensitivity and specificity, and area under the receiver operator curve and determine if there are better combination of clinical and diagnostic predictors for diagnosis of pneumonia in children.

Area under the receiver operator curve (ROC)

时间窗: 1 day

We will follow patients during their acute visit to evaluate accuracy of clinical history, physical exam findings (including WHO criteria for diagnosing pneumonia), laboratory findings, and lung ultrasound using chest radiographs as the standard for diagnosing pneumonia. We will determine the sensitivity and specificity, and area under the receiver operator curve and determine if there are better combination of clinical and diagnostic predictors for diagnosis of pneumonia in children.

次要结局

未报告次要终点

研究者

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

Darlene Rose House

Assistant Professor of Clinical Emergency Medicine

Patan Academy of Health Sciences

研究点 (1)

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