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Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal

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ClinicalTrials.gov Identifier: NCT02949141
Recruitment Status : Completed
First Posted : October 31, 2016
Results First Posted : July 24, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
Vanderbilt University
Indiana University School of Medicine
Information provided by (Responsible Party):
Darlene Rose House, Patan Academy of Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Device: Lung Ultrasound Device: Chest X-ray Device: Chest Computed Tomography (CT) Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Use of Lung Ultrasound Compared to Chest X-Ray for Suspected Pneumonia in Nepal
Study Start Date : November 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: Ultrasound
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
All patients will receive lung ultrasound, chest x-ray and computed tomography

Device: Chest X-ray
All patients will receive chest x-ray as per usual care for evaluation for pneumonia

Device: Chest Computed Tomography (CT)
All enrolled patients will receive a CT scan as the gold standard for diagnosing pneumonia




Primary Outcome Measures :
  1. Diagnosis of Pneumonia [ Time Frame: 9 months ]
    Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, 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.

Information from the National Library of Medicine

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): NCT02949141


Sponsors and Collaborators
Patan Academy of Health Sciences
Vanderbilt University
Indiana University School of Medicine
Investigators
Study Chair: Bharat Yadav, MD Chair of Department of Emergency Medicine
  Study Documents (Full-Text)

Documents provided by Darlene Rose House, Patan Academy of Health Sciences:
Informed Consent Form  [PDF] May 16, 2016


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Darlene Rose House, Assistant Professor of Clinical Emergency Medicine and Pediatrics, Patan Academy of Health Sciences
ClinicalTrials.gov Identifier: NCT02949141     History of Changes
Other Study ID Numbers: Pahs
First Posted: October 31, 2016    Key Record Dates
Results First Posted: July 24, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections