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Completed

NCT Number: NCT03744169

Use of Lung Ultrasound to Diagnose the Etiology of Respiratory Failure in a PICU.

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.

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Key information

Conditions

Pediatric Respiratory Diseases Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin, American Family Children's Hospital

Madison, Wisconsin, 53792, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Ultrasound

Diagnostic Test

A point-of-care lung ultrasound exam will be performed on admission (no later than 14 hours following admission, allowing for participant stabilization and care) to the PICU and within 6 hours of any escalation in mechanical ventilatory support without interrupting clinical care, by study investigators blinded to participant history, physical examination, and diagnostic testing/imaging and who are not involved in the clinical management of the participant. Investigators will use a six-zone standardized scanning protocol with pattern analysis to form a diagnosis for the cause of the participant's respiratory failure. Images will be acquired by pediatric critical care trainees and saved online; accuracy of diagnoses based on the ultrasound exam will be evaluated by a expert sonographer offline.

Clinical exam

Diagnostic Test

Following morning ICU rounds, the PICU fellow or attending physician caring for the participant will be asked for his/her interpretation of the most recent chest radiograph and his/her diagnosis concerning the etiology of the participant's acute respiratory failure. This clinical diagnosis will be compared to ultrasound findings.

Chest X-Ray

Diagnostic Test

Results of chest x-ray will be collected for comparison with ultrasound findings.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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).

Secondary outcomes

  1. Inter-observer reliability of point-of-care lung ultrasound examination findings in acute pediatric respiratory failure among trainee and expert sonographers

    Time frame: Following acquisition and interpretation of ultrasound images, an average of less than one week

    Ultrasound images obtained by a critical care trainee will be saved online for review by an expert sonographer. The expert sonographer will overread the images; findings will be compared at all ultrasound points to determine percent agreement in interpreting ultrasound exam findings between the trainee and expert sonographer. Additionally final ultrasonographic diagnosis will be compared between trainee and expert sonographers. Interpretation of exam findings and determination of exam diagnosis will be compared to determine the inter-observer reliability of point-of-care lung ultrasound exams in acute pediatric respiratory failure. The hypothesis is that the inter-observer reliability between trainee and expert sonographers for point-of-care lung ultrasound findings will be >80%.

Other outcomes

  1. Rate of pneumothorax detection between point-of-care lung ultrasound and chest radiography

    Time frame: 6 hours before or after completion of chest x-ray

    Chest x-rays findings (as determine by board certified pediatric radiologists) obtained during the course of routine clinical care will be compared to point-of-care lung ultrasound examinations when completed within 6 hours of each other. The hypothesis is that lung ultrasound will have a higher rate of detection of when compared with a chest radiograph taken less than 6 hours prior to or less than 6 hours after lung ultrasound examination.

  2. Rate of pleural effusion detection between point-of-care lung ultrasound and chest radiography

    Time frame: 6 hours before or after completion of chest x-ray

    Chest x-rays findings (as determine by board certified pediatric radiologists) obtained during the course of routine clinical care will be compared to point-of-care lung ultrasound examinations when completed within 6 hours of each other. The hypothesis is that lung ultrasound will have a higher rate of detection of when compared with a chest radiograph taken less than 6 hours prior to or less than 6 hours after lung ultrasound examination.

  3. Rate of interstitial edema detection between point-of-care lung ultrasound and chest radiography

    Time frame: 6 hours before or after completion of chest x-ray

    Chest x-rays findings (as determine by board certified pediatric radiologists) obtained during the course of routine clinical care will be compared to point-of-care lung ultrasound examinations when completed within 6 hours of each other. The hypothesis is that lung ultrasound will have a higher rate of detection of when compared with a chest radiograph taken less than 6 hours prior to or less than 6 hours after lung ultrasound examination.

  4. Rate of alveolar consolidation detection between point-of-care lung ultrasound and chest radiography

    Time frame: 6 hours before or after completion of chest x-ray

    Chest x-rays findings (as determine by board certified pediatric radiologists) obtained during the course of routine clinical care will be compared to point-of-care lung ultrasound examinations when completed within 6 hours of each other. The hypothesis is that lung ultrasound will have a higher rate of detection of when compared with a chest radiograph taken less than 6 hours prior to or less than 6 hours after lung ultrasound examination.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2018
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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