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A Randomized Controlled Trial of Lung Ultrasound Compared to Chest X-ray for Diagnosing Pneumonia in the Emergency Department

NCT01654887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2017-03-10

Study results available
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Summary

The primary objective of this study is to determine if lung ultrasound (LUS) can replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, we are looking for an overall reduction of CXR when LUS is used first. Our null hypothesis is that LUS cannot replace CXR for diagnosing pneumonia. Our alternate hypothesis is that LUS can replace CXR for diagnosing pneumonia. Our secondary objectives include: (1) a comparison of unscheduled healthcare visits after the index Emergency Department (ED) visit between those subjects who undergo CXR first and those who undergo LUS first, (2) an evaluation of the rate of antibiotic use between the two groups, (3) a comparison of the admission rates, and (4) a comparison of the length of stay in the Emergency Department between the two groups.

Conditions

Interventions

OTHER

Lung Ultrasound

Six anatomic areas, delineated by the anterior, posterior, and mid- axillary lines will be systematically examined bilaterally, as per the modified Bedside Lung Ultrasound in Emergency (BLUE) protocol (Lichtenstein 2008). Ultrasound images will be obtained in longitudinal and transverse orientation, and recorded.

RADIATION

Chest X-Ray

Posterior-Anterior and lateral views of the chest via chest radiography followed by a lung ultrasound which is comprised of six anatomic areas, delineated by the anterior, posterior, and mid- axillary lines will be systematically examined bilaterally, as per the modified Bedside Lung Ultrasound in Emergency (BLUE) protocol (Lichtenstein 2008). Ultrasound images will be obtained in longitudinal and transverse orientation, and recorded.

Sponsors & Collaborators

Principal Investigators

  • James Tsung, MD, MPH · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01654887 on ClinicalTrials.gov