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 September 2014 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: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition
Wheezing
Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study Evaluating the Use of Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department With Wheezing

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452945

Locations
United States, District of Columbia
Children's National Medical Center Division of Emergency Medicine Recruiting
Washington, District of Columbia, United States, 10010
Contact: Joanna S Cohen, MD    202-476-4177    jcohen@cnmc.org   
Principal Investigator: Joanna S Cohen, MD         
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Joanna S Cohen, MD Childrens National Medical Center
  More Information

Publications:
Responsible Party: Joanna Cohen, Assistant Professor of Pediatrics and Emergency Medicine, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01452945     History of Changes
Other Study ID Numbers: Pro00002000
Study First Received: October 13, 2011
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 19, 2014