A Randomized Controlled Trial of Lung Ultrasound Compared to Chest X-ray for Diagnosing Pneumonia in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT01654887|
Recruitment Status : Completed
First Posted : August 1, 2012
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Other: Lung Ultrasound Radiation: Chest X-Ray||Not Applicable|
Background - Ultrasound is now widely accepted as a diagnostic tool for use in the emergency department, as supported by the American College of Emergency Physicians position statement in 2001 (revised in 2008). Evidence-based guidelines for point-of-care lung ultrasound have recently been published (Volpicelli et al 2012). Lichtenstein et al (2004) performed bedside LUS on 117 critically ill patients to evaluate for alveolar consolidation and compared these findings with CT, the gold standard. Sensitivity of ultrasound was 90% and specificity 98%, indicating that US is a feasible imaging modality for the lungs. Copetti et al (2008) compared the diagnostic accuracy of LUS and CXR in children with suspected pneumonia. 79 children underwent LUS and CXR. Lung ultrasound was positive for the diagnosis of pneumonia in 60 patients, whereas CXR was positive in 53. Copetti concluded that LUS is as reliable as CXR in diagnosing pneumonia plus it has the added benefit of no radiation exposure for patients. Shah et al (2009) found LUS to be superior to CXR in detecting pneumonia. 200 patients with suspected pneumonia were enrolled and underwent LUS and CXR. LUS detected 49 pneumonias whereas CXR detected 36. The 13 cases of radiographically occult pneumonia that were identified by LUS were all less than 1 centimeter in diameter, suggesting that LUS is superior in identifying early and/or small pulmonary consolidations. This particular study found that LUS was able to detect pneumonia with a Sensitivity of 86% and a Specificity of 97%. Additionally, Tsung et all (2009) found that it is feasible to use ultrasound to distinguish viral from bacterial pneumonia, thus indicating another striking advantage to LUS. From these studies, it is clear that lung ultrasound plays a role in the diagnosis of pulmonary pathology and moreover it is possible that LUS may replace CXR as the imaging modality of choice. This study is designed as a comparative effectiveness randomized controlled trial between ultrasound and chest x-ray for diagnosing pneumonia. The study cited above performed by Shah et al 2009 forms the basis of our pilot data in planning this randomized controlled trial. In Dr. Shah's study, there were no missed pneumonias and no over or under treatment of pneumonia when pneumonia was diagnosed on lung ultrasound.
Study Design - Currently CXR is the standard of care for the detection of pneumonia, however, there is published evidence that demonstrates LUS is as reliable as CXR and even surpasses CXR in detecting small and/or early pneumonias as well differentiating viral from bacterial processes as cited above (Lichtenstein et al 2004; Copetti et al 2008; Shah et al 2009; Tsung et al 2012).
The motivation for conducting this study is that we have possibly identified an imaging modality that is better than our current standard of care. It is our primary aim to compare the two imaging modalities to clinical outcomes to see if subjects in the investigational arm have better outcomes than those in the control arm who receive the standard of care.
The attending physician or fellow caring for the patient will determine if the patient is eligible. If the ED provider clearly identifies a pneumonia on the ultrasound then the patient will be diagnosed and treated for pneumonia without being subjected to the unnecessary radiation of a CXR. However, if the provider does not clearly identify a pneumonia on ultrasound or if the LUS fails to detect a pneumonia and the clinical suspicion remains high, then the provider has the option to proceed to the CXR to assist in the diagnosis of pneumonia. Alternatively, all subjects randomized to the control arm will under a CXR first followed by a LUS, because LUS can often provide additional information that CXR does not as noted above (e.g. the ability to differentiate between viral and pneumonia infections).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Effectiveness of Lung Ultrasound vs. Chest X-ray for the Diagnosis of Pneumonia in the Emergency Department|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Lung Ultrasound
LUS first with the option of obtaining CXR second
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.
Other Name: LUS
Active Comparator: Chest X-Ray
CXR first followed by LUS second
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.
Other Name: CXR
- Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia [ Time Frame: up to 5 hours ]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.
- Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR [ Time Frame: week 1-2 ]
- Comparison of Unscheduled Healthcare Visits [ Time Frame: week 1-2 ]Percentage of participants who had unscheduled healthcare visits after the index Emergency Department visit between those subjects who undergo CXR first and those who undergo LUS first.
- Percentage of Participants With Antibiotic Use [ Time Frame: weeks 1-2 ]A chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was started on antibiotics during the index Emergency Department (ED) visit or at a later healthcare visit.
- Percentage of Participants Who Had Hospital Admission. [ Time Frame: weeks 1-2 ]Chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.
- Comparison of the Length of Stay in the ED [ Time Frame: up to 5 hours ]Chart review conducted to assess overall LOS in the ED.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654887
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||James Tsung, MD, MPH||Icahn School of Medicine at Mount Sinai|