An interventional study of Lung Ultrasound and Chest X-ray in Pneumonia, sponsored by Patan Academy of Health Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by Patan Academy of Health Sciences · Not applicable, Interventional, and Diagnostic
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.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's enrollment of 62 is below the median of 129 across 975 interventional studies indexed under Pneumonia.
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Exclusion Criteria:
All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)
Device: Lung Ultrasound · Device: Chest X-ray · Device: Chest Computed Tomography (CT)
All patients will receive lung ultrasound, chest x-ray and computed tomography
All patients will receive chest x-ray as per usual care for evaluation for pneumonia
All enrolled patients will receive a CT scan as the gold standard for diagnosing pneumonia
Diagnosis of Pneumonia
Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.
Time frame: 9 months
| Milestone | All Participants |
|---|---|
| Started | 62 |
| Completed | 62 |
| Not completed | 0 |
Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.
| Participants | Ultrasound | Chest X-Ray |
|---|---|---|
| US (or CXR) and CT positive pneumonia | 40 | 32 |
| US (or CXR) negative, CT positive | 4 | 12 |
| US (or CXR) positive, CT negative | 7 | 9 |
| US (or CXR) negative, CT negative | 11 | 9 |
Collected over Adverse event data were collected during hospital stay.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrasound | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Chest X-ray | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Chest Ct | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Age, Categorical(Participants) | Ultrasound |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 47 |
| >=65 years | 15 |
| Age, Continuous(years) | Ultrasound |
|---|---|
| Mean | 59.2 ± 14.5 |
| Sex: Female, Male(Participants) | Ultrasound |
|---|---|
| Female | 33 |
| Male | 29 |
| Race and Ethnicity Not Collected(Participants) | Ultrasound |
|---|
| Region of Enrollment(participants) | Ultrasound |
|---|---|
| Nepal | 62 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Nov 2016, a primary completion of Apr 2017 and a completion of May 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2017, 3 months after primary completion.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Patan Academy of Health Sciences