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

NCT ID: NCT03744169

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-02-29

Brief Summary

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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

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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

Conditions

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Pediatric Respiratory Diseases Respiratory Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with acute respiratory failure

Point-of-care lung ultrasound on admission to the PICU to determine the cause of respiratory failure.

Lung ultrasound

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Chest x-ray

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Kory, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin, American Family Children's Hospital

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Reference Type DERIVED
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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A534285

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/PULMON MED

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/7/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0711

Identifier Type: -

Identifier Source: org_study_id

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