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

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ClinicalTrials.gov Identifier: NCT03744169
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Pediatric Respiratory Diseases Respiratory Failure Diagnostic Test: Lung ultrasound Diagnostic Test: Clinical exam Diagnostic Test: Chest x-ray

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

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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Point-of-care Lung Ultrasound to Diagnose the Etiology of Acute Respiratory Failure in a Pediatric Intensive Care Unit.
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744169


Locations
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United States, Wisconsin
University of Wisconsin, American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Pierre Kory, MD University of Wisconsin, Madison
Publications:
Kader, M., et al., The utility of lung ultrasound in evaluation ofinfants with suspected bronchiolitis.Egypt J of Rad and Nuc Med, 2016. 47(3): p. 1057.
Lichtenstein, D.A. and G.A. Meziere, The BLUE-points: threestandardized points used in the BLUE-protocol for ultrasound assessment of thelung in acute respiratory failure.Critical Ultrasound Journal, 2011. 3(2): p. 109-110.

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03744169    
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 )
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases