跳至主要内容
临床试验/NCT03744169
NCT03744169已完成不适用

Use of Point-of-care Lung Ultrasound to Diagnose the Etiology of Acute Respiratory Failure in a Pediatric Intensive Care Unit.

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年12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
88
试验地点
1
主要终点
Sensitivity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU

研究概览

简要总结

The purpose of this study is to determine the utility of point-of-care lung ultrasound (POC-LUS) in identifying the etiology of acute respiratory failure in pediatric patients admitted to the pediatric intensive care unit.

详细描述

Respiratory failure is one of the most common conditions requiring admission to the pediatric intensive care unit (PICU). As such, chest radiography has emerged as the most commonly utilized tool in the assessment of lung pathology despite evidence that it may not be the most accurate. Since the seminal article by Lichtenstein in 2008, lung ultrasound has emerged as an alternative to chest radiography in the assessment of critically ill adults. Likewise, pediatric lung ultrasound has a growing body of research to support its use in commonly encountered lung pathology including pneumonia, asthma, bronchiolitis, acute chest syndrome, pleural effusions, and pneumothorax. Despite the rapidly growing body evidence, there remains little literature to support its use the diagnosis and management of acute respiratory failure in the PICU.

The proposed study will evaluate whether point-of-care lung ultrasound is accurate in determining the etiology of acute respiratory failure on admission to the PICU.

Specific aims include:

  • Aim 1: To determine the sensitivity and specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU.
  • Aim 2: To determine the inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers.
  • Aim 3: Compare point-of-care lung ultrasound with chest radiography in the rate of detection of consolidation, interstitial edema, pneumothorax, and pleural effusion.
  • Aim 4: Describe the POC-LUS findings in patients admitted to the PICU with acute respiratory failure

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age greater than 37 weeks gestational age and less than 18 years
  • Admitted to PICU
  • Clinical diagnosis of acute respiratory failure
  • Requirement of non-invasive or invasive respiratory support (as defined by a clinical need for high flow nasal cannula >1L/kg/min; RAM cannula, nasal or full face mask delivered continuous positive airway pressure ventilation; RAM cannula, nasal or full face mask delivered bi-level positive airway pressure ventilation; or invasive mechanical ventilation); requirement of supplemental oxygen with FiO2 > 0.35 while on high flow nasal cannula <1L/kg/min to maintain saturations > 90%; continuous nebulized therapy; or chronic use of home oxygen or ventilator support AND any increase in home settings

排除标准

  • Hemodynamically unstable as defined by the initiation of or the need for increased vasopressor support within the previous 30 minutes
  • Known chronic respiratory disease such as primary ciliary dyskinesia, cystic fibrosis, or congenital pulmonary malformations.

结局指标

主要结局

Sensitivity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU

时间窗: up to one month

The sensitivity of the lung ultrasound in identifying the etiology of acute pediatric respiratory failure will be determined by comparison with the final criterion or "gold standard" diagnosis generated by a blinded review of the chart after discharge by a study investigator blinded to the case. The hypothesis is that the lung ultrasound performed on admission to the PICU will have a sensitivity of \> 90% in determining the etiology of acute respiratory failure in children (as determined by an independent review of the participant's medical record following hospital discharge).

Specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU

时间窗: up to one month

The specificity of the lung ultrasound in identifying the etiology of acute pediatric respiratory failure will be determined by comparison with the final criterion or "gold standard" diagnosis generated by a blinded review of the chart after discharge by a study investigator blinded to the case. The hypothesis is that the lung ultrasound performed on admission to the PICU will have a specificity of \> 90% in determining the etiology of acute respiratory failure in children (as determined by an independent review of the participant's medical record following hospital discharge).

次要结局

  • Inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers(Following acquisition and interpretation of ultrasound images, an average of less than one week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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