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?
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.
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
Start Date: August 2012
Completed Date: July 2013
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
Emergency Ultrasound Guidelines. Policy Statement by the American College of Emergency Physicians (revised in October 2008)