Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Children's Research Institute
Sponsor:
Information provided by (Responsible Party):
Joanna Cohen, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01452945
First received: October 13, 2011
Last updated: October 19, 2012
Last verified: October 2012

October 13, 2011
October 19, 2012
October 2012
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Complete list of historical versions of study NCT01452945 on ClinicalTrials.gov Archive Site
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Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing
Prospective Observational Study Evaluating the Use of Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department With Wheezing

Young children presenting to the Emergency Department (ED) with wheezing often have prolonged stays in the ED or even get admitted to the hospital. This is a prospective observational study in which the investigators will use bedside 2D ultrasound to evaluate the lung ultrasound findings in children less than 24 months presenting to the ED with wheezing.

The investigators hypothesize that children less than 24 months presenting to the Emergency Department with wheezing will have a range of lung ultrasound findings that will include normal findings, B lines, subpleural consolidations, and pleural effusions. The investigators also hypothesize that the findings will be reproducible between two equally trained providers.

The investigators also hypothesize that lung ultrasound findings patients 0-24 months presenting to the ED with wheezing will correlate with specific clinical outcomes. An exploratory analysis will be performed to look for correlations between lung US findings and acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy, response to treatment and radiologic or viral studies if performed.

Specific Aim 1: To qualify lung US findings in a convenience sample of young children presenting to the ED with bronchiolitis with review by a second provider to determine the reproducibility of the findings.

reproducibility of the findings.

Hypothesis 1a: Children less than 24 months presenting to the Emergency Department with wheezing will have a range of lung ultrasound findings that will include normal findings, B lines, subpleural consolidations, and pleural effusions.

Hypothesis 1b: Findings will be reproducible between two equally trained providers.

Specific Aim 2: The frequency of B lines, subpleural consolidations, and pleural effusions on lung US in a convenience sample of patients 0-24 months presenting the ED with wheezing will be quantified using continuous variable means and standard deviations. An exploratory analysis will be performed to look for correlations between lung US findings and clinical outcomes including discharge from the ED or admission to the hospital, including the intensive care unit, and length of stay in the ED. A further exploratory analysis will be done to look for correlations between lung ultrasound findings and acute severity, final diagnosis, presenting symptoms, prematurity and risk factors for atopy.

Hypothesis 2a: The presence of B lines, subpleural consolidations, and pleural effusions on lung US in a convenience sample of patients 0-24 months presenting the ED with wheezing will correlate with specific clinical outcomes.

Hypothesis 2b: The presence of B lines, subpleural consolidations, and pleural effusions on lung US in a convenience sample of patients 0-24 months presenting the ED with wheezing will positively correlate with a history of prematurity and negatively correlate with a history consistent with atopy.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Children 0-24 months presenting to a pediatric Emergency Department with wheezing

  • Wheezing
  • Bronchiolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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Inclusion Criteria:

  • Age less than or equal to 24 months
  • Presenting to the pediatric ED with wheezing

Exclusion Criteria:

  • On home oxygen at baseline
  • Cyanotic congenital cardiac disease (including: ToF, TAPVR, HLHS, d-TGA, TA, pulm atresia, critical pulm stenosis, but not including VSD, ASD, Coarctation of the Aorta)
  • Endotracheal tube or tracheostomy in place and/or receiving mechanical ventilation
  • Transferred from an outside hospital
Both
up to 24 Months
No
United States
 
NCT01452945
Pro00002000
No
Joanna Cohen, Children's Research Institute
Children's Research Institute
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Principal Investigator: Joanna S Cohen, MD Childrens National Medical Center
Children's Research Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP