Clinical trial NCT03744169: Use of Lung Ultrasound to Diagnose the Etiology of Respiratory Failure in a PICU.
Official title: Use of Point-of-care Lung Ultrasound to Diagnose the Etiology of Acute Respiratory Failure in a Pediatric Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Respiratory Diseases
Respiratory Failure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 88
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients age greater than 37 weeks gestational age and less than 18 years old with a clinical diagnosis of acute respiratory failure and the need for non-invasive (HFNC \> 1 L/kg/min, CPAP, or BiPAP) or invasive mechanical ventilation.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sensitivity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU
timeFrame: up to one month
measure: Specificity of point-of-care lung ultrasound examination in identifying the etiology of acute pediatric respiratory failure on admission to the PICU
timeFrame: up to one month
Secondary outcomes:
measure: Inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers
timeFrame: Following acquisition and interpretation of ultrasound images, an average of less than one week
Other outcomes:
measure: Rate of pneumothorax detection between point-of-care lung ultrasound and chest radiography
timeFrame: 6 hours before or after completion of chest x-ray
measure: Rate of pleural effusion detection between point-of-care lung ultrasound and chest radiography
timeFrame: 6 hours before or after completion of chest x-ray
measure: Rate of interstitial edema detection between point-of-care lung ultrasound and chest radiography
timeFrame: 6 hours before or after completion of chest x-ray
measure: Rate of alveolar consolidation detection between point-of-care lung ultrasound and chest radiography
timeFrame: 6 hours before or after completion of chest x-ray
Locations:
city: Madison
country: United States
facility: University of Wisconsin, American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Pierre Kory, MD
role: PRINCIPAL_INVESTIGATOR
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