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

NCT01654887 | Completed Results DMC

• 2 other identifiers: GCO 12-0428HSM# 12-00153
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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

Pneumonia

Keywords

Comparative Effectiveness; Lung Ultrasound versus Chest X-ray; Pneumonia; Emergency Department

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia

  The percentage of Participants For Whom CXR Was Not Needed (or received only lung US) to Diagnose Pneumonia. The primary objective of this study is to determine if it is possible for lung ultrasound (LUS) to replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, an overall reduction of CXR when LUS is used first. Null hypothesis is that LUS cannot replace CXR for the diagnosis of pneumonia. Alternate hypothesis is that LUS can replace CXR for pneumonia.

  up to 5 hours

• Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR

  week 1-2

Secondary Outcomes (4)

• Comparison of Unscheduled Healthcare Visits

  week 1-2

• Percentage of Participants With Antibiotic Use

  weeks 1-2

• Percentage of Participants Who Had Hospital Admission.

  weeks 1-2

• Comparison of the Length of Stay in the ED

  up to 5 hours

Study Arms (2)

Lung Ultrasound

EXPERIMENTAL

LUS first with the option of obtaining CXR second

Other: Lung Ultrasound

Chest X-Ray

ACTIVE COMPARATOR

CXR first followed by LUS second

Radiation: Chest X-Ray

Interventions

Lung Ultrasound OTHER

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.

Also known as: LUS

Lung Ultrasound

Chest X-Ray RADIATION

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.

Also known as: CXR

Chest X-Ray

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients who present to the ED with respiratory symptoms suspicious for pneumonia
• In whom the treating physician believes would benefit from diagnostic imaging

You may not qualify if:

• Patients who arrive at the ED with a previously performed CXR
• Unstable patients with life-threatening injuries who require ongoing resuscitation

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (7)

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

  BACKGROUND

• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

  PMID: 22392031 BACKGROUND

• Lichtenstein DA, Lascols N, Meziere G, Gepner A. Ultrasound diagnosis of alveolar consolidation in the critically ill. Intensive Care Med. 2004 Feb;30(2):276-281. doi: 10.1007/s00134-003-2075-6. Epub 2004 Jan 13.

  PMID: 14722643 BACKGROUND

• Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.

  PMID: 18386121 BACKGROUND

• Shah et al. "The Feasibility of Diagnosing Pediatric Pneumonia Using Point-of-Care Ultrasound." Pediatric Emergency Care. American Academy of Pediatrics, Section on Emergency Medicine, Scientific Abstract Presentations, AAP National Conference and Exhibition, October 16, 2009 Y Washington, DC. Ped Emerg Care. Volume 25(10), October 2009, pp 704-712.

  BACKGROUND

• Tsung JW, Kessler DO, Shah VP. Prospective application of clinician-performed lung ultrasonography during the 2009 H1N1 influenza A pandemic: distinguishing viral from bacterial pneumonia. Crit Ultrasound J. 2012 Jul 10;4(1):16. doi: 10.1186/2036-7902-4-16.

  PMID: 22862998 BACKGROUND

• Jones BP, Tay ET, Elikashvili I, Sanders JE, Paul AZ, Nelson BP, Spina LA, Tsung JW. Feasibility and Safety of Substituting Lung Ultrasonography for Chest Radiography When Diagnosing Pneumonia in Children: A Randomized Controlled Trial. Chest. 2016 Jul;150(1):131-8. doi: 10.1016/j.chest.2016.02.643. Epub 2016 Feb 26.

  PMID: 26923626 DERIVED

MeSH Terms

Conditions

Pneumonia; Emergencies

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Dr. James Tsung
• Organization: Icahn School of Medicine at Mount Sinai

james.tsung@mountsinai.org

212-241-6272

Study Officials

• James Tsung, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 10, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-01

Locations

US (1)