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

Bronchiolitis Clinical Trial

Official title:

Prospective Observational Study Evaluating the Use of Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department With Wheezing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452945
• Other study ID #: Pro00002000
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: May 19, 2015
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Wheezing

Locations

Country	Name	City	State
United States	Children's National Medical Center Division of Emergency Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

Caiulo VA, Gargani L, Caiulo S, Fisicaro A, Moramarco F, Latini G, Picano E. Lung ultrasound in bronchiolitis: comparison with chest X-ray. Eur J Pediatr. 2011 Nov;170(11):1427-33. doi: 10.1007/s00431-011-1461-2. Epub 2011 Apr 6. — View Citation

Copetti R, Cattarossi L, Macagno F, Violino M, Furlan R. Lung ultrasound in respiratory distress syndrome: a useful tool for early diagnosis. Neonatology. 2008;94(1):52-9. doi: 10.1159/000113059. Epub 2008 Jan 15. — View Citation

Lichtenstein D, Mézière G, Biderman P, Gepner A, Barré O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. — View Citation

Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. — View Citation