Diagnostic Use of Lung Ultrasound Compared to Chest X-Ray for Suspected Pneumonia in Nepal
Phase: NA
Conditions: Pneumonia
Sponsor: Patan Academy of Health Sciences

 
 
Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal 
 
NCT02949141 
 
May 16, 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Introduction 
 
Pneumonia is one of the leading causes of death worldwide.[1] In Nepal, 
pneumonia is the leading cause of death.[1, 2] These deaths can be prevented 
with early diagnosis that allows patients to get appropriate treatment. The 
diagnosis, however, is not always clear on presentation to health care facilities. 
Diagnosis can often depend on the patient’s ability to pay and the facilities 
diagnostic capabilities. Imaging for pneumonia usually includes a chest x-ray 
(CXR), or in some cases, a thoracic computed tomography (CT) scan. While the 
latter is the diagnostic gold standard, it is associated with high costs and high 
doses of radiation.[3, 4] Therefore, chest x-ray continues to be the main 
diagnostic modality for pneumonia despite its low sensitivity.[4, 5]  
 
Several studies in high-income countries have shown ultrasound to be a reliable 
tool to diagnose pneumonia with a higher sensitivity and specificity than chest x-
ray.[6-10] Ultrasound is a safe, portable and inexpensive diagnostic modality 
that is widely used in resource-limited countries. [11] However, use of 
ultrasound to diagnose pneumonia in resource-limited settings like Nepal has 
not yet been studied.  
 
This study will allow us to determine if clinicians in Nepal are able to use 
ultrasound to diagnose pneumonia. Given the ease, portability, and relative ease 
of teaching ultrasound, this would be potential technology available for many 
clinicians throughout Nepal to use for patients presenting with suspected 
pneumonia. This would be especially useful in remote areas where clinicians 
have limited access to x-rays.  
 
To determine effectiveness of ultrasound compared to chest X-ray for diagnosis 
of pneumonia in patients presenting to an emergency department in Nepal. 
 
IV. Methodology 
 
Study Design: A prospective, convenience sample of patients presenting with 
suspected pneumonia when trained ultrasound physicians are present in the 
Patan Hospital Emergency Department was performed in Kathmandu, Nepal. 
This study was done in partnership with Patan Hosptial Emergency Department 
with the ethical approval from Nepal Health Research Council.   
 
Study Setting: Located in the Kathmandu valley, Patan Hospital is a large urban 
hospital with 35-bed Emergency Department that sees approximately 32,000 
patients per year.  
 
Study Population: 
 
Inclusion criteria: Patients presenting to the Emergency Department at Patan 
Hospital age 18 or older with suspected signs of pneumonia with at least three of 
the following: temperature greater than 38 or history of fever, cough, dyspnea, 
heart rate higher than 100 beats per minute, tachypnea (RR>20), or oxygen 
saturation lower than 92%. 

 
Exclusion criteria: Children will be excluded from the study. Also, ultrasound 
studies completed by physicians not trained in lung ultrasound will not be 
included.  
 
Study Protocol: 
 
Prior to the enrolling patients, clinicians in the ED will save lung ultrasound 
exams and interpret their exams. These exams will then reviewed by an 
ultrasonographer to ensure adequate skill in lung ultrasonography. A kappa 
analysis of these scans will be performed. If kappa <0.6, we will review lung 
ultrasound with these clinicians and repeat above evaluation until kappa of 0.6 is 
achieved. 
 
For patients meeting inclusion criteria, consent will be obtained from the patient 
to participate in the study. Consent will include explanation of use of bedside 
ultrasound and chest CT scan for diagnosis of their condition. This consent will 
also include explanation of risks and benefits in Nepali (see attached consent 
form). These examinations will be provided free of charge to the patient.  
 
The physician will record patient demographics, symptoms, lung exam findings, 
and pre-test probablility of pneumonia (low, intermediate, high) on the data 
form (see attached).  
 
After initial clinical evaluation, a bedside lung ultrasound will be performed. A 
Sonosite M Turbo (Fujifilm Sonosite, Inc.) ultrasound machine will be used. The 
ultrasound examination will include ten views, two anterior views and two 
lateral views (one including the costophrenic angle), and one posterior view on 
both chest walls. The physician will then record findings and diagnosis on the 
data entry form along with their post-test probablility of pneumonia (low, 
intermediate, high).  
 
Patients will get a chest x-ray as a part of the standard evaluation. These 
readings will be recorded on the data sheet. Patients will then undergo a chest 
CT, as the diagnostic standard to evaluate for pneumonia. The CT will be read by 
a radiologist. The radiologist will be blinded to the results of the previous 
studies. The reading and diagnosis will be recorded on the data form. 
 
 
Statistical Analysis 
 
The performance of ultrasound for diagnosis of pneumonia will be expressed as 
sensitivity, specificity, and likelihood ratios. Since the sensitivity of ultrasound is 
estimated around 90%, in order to detect a 20% difference based on a CXR 
sensitivity of 70%, 62 patients will be needed. McNemar’s test will be used to 
evaluate any statistical difference in sensitivity between CXR and US.  
 
 
 

 
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