Pneumonia Clinical Trial
Official title:
Diagnostic Use of Lung Ultrasound Compared to Chest X-Ray for Suspected Pneumonia in Nepal
This study is designed to evaluate the use of lung ultrasound compared to chest x-ray to diagnose pneumonia in Nepal. Given the ease, portability, and relative ease of teaching ultrasound, this would be potential technology available for many clinicians throughout Nepal to use for adult and pediatric patients presenting with suspected pneumonia. This would be especially useful in remote areas where clinicians have limited access to x-rays. Despite its utility, use of ultrasound to diagnose pneumonia in resource-limited settings like Nepal has not yet been studied. Therefore, this study is designed as a prospective, clinical diagnostic study to evaluate patients presenting with suspected pneumonia using diagnostic imaging of beside ultrasound compared with chest x-ray using computed tomography as the gold standard for diagnosis of pneumonia.
Study Design: A prospective, convenience sample of participants presenting with suspected
pneumonia when trained ultrasound investigator is present in the Patan Hospital Emergency
Department will be performed in Patan, Nepal. This study will be done in partnership with
Patan Hospital Emergency Department and with the approval of Nepal Health Research Council
and Patan Hospital's ethical review committee.
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 Protocol:
Prior to the enrolling patients, investigators in the Emergency Department will save lung
ultrasound exams and interpret the exams. These exams will then be independently 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
investigators and repeat above evaluation until kappa of 0.6 is achieved.
For participants meeting inclusion criteria, consent will be obtained from the participant.
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. These examinations will be provided free of charge to the participant.
The investigator will record patient demographics, symptoms, lung exam findings, and pre-test
probability of pneumonia (low, intermediate, high) on the data form.
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, two lateral views (one including the costophrenic
angle), and one posterior view on both chest walls. The investigator will then record
findings and diagnosis on the data entry form along with their post-test probability of
pneumonia (low, intermediate, high).
Participants will get a chest x-ray as a part of the standard evaluation. These readings will
be recorded on the data sheet. Participants will then undergo a chest computed tomography
(CT), as the diagnostic standard to evaluate for pneumonia. The chest x-ray and chest CT will
be read by a radiologist. The radiologist will be blinded to the results of the previous
studies. The reading and diagnosis according to CT 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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