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

Pneumonia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - All patients who present to the ED with respiratory symptoms suspicious for pneumonia - In whom the treating physician believes would benefit from diagnostic imaging Exclusion Criteria: - Patients who arrive at the ED with a previously performed CXR - Unstable patients with life-threatening injuries who require ongoing resuscitation

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pneumonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Lung UltrasoundSix 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-RayPosterior-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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Lung UltrasoundLUS first with the option of obtaining CXR second

Chest X-RayCXR first followed by LUS second

Study Status

Completed

Start Date: August 2012

Completed Date: July 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia

Secondary Outcome: Comparison of Unscheduled Healthcare Visits

Study sponsors, principal investigator, and references

Principal Investigator: James Tsung, MD, MPH

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01654887

Emergency Ultrasound Guidelines. Policy Statement by the American College of Emergency Physicians (revised in October 2008)

Discuss Pneumonia