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

June 19, 2020 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin, American Family Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with acute respiratory failure
Point-of-care lung ultrasound on admission to the PICU to determine the cause of respiratory failure.
Diagnostic test: Lung ultrasound
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.
Diagnostic test: Clinical exam
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.
Diagnostic test: Chest x-ray
Results of chest x-ray will be collected for comparison with ultrasound findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to one month
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).
up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Following acquisition and interpretation of ultrasound images, an average of less than one week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours before or after completion of chest x-ray
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.
6 hours before or after completion of chest x-ray
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.
6 hours before or after completion of chest x-ray
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.
6 hours before or after completion of chest x-ray

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0711
  • A534285 (Other Identifier: UW Madison)
  • SMPH/MEDICINE/PULMON MED (Other Identifier: UW, Madison)
  • Protocol Version 4/7/2020 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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