Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lung Ultrasound
Chest X-ray
Chest Computed Tomography (CT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02949141
First Posted
October 25, 2016
Last Updated
August 19, 2017
Sponsor
Patan Academy of Health Sciences
Collaborators
Vanderbilt University, Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02949141
Brief Title
Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal
Official Title
Diagnostic Use of Lung Ultrasound Compared to Chest X-Ray for Suspected Pneumonia in Nepal
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Patan Academy of Health Sciences
Collaborators
Vanderbilt University, Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Lung Ultrasound
Intervention Description
All patients will receive lung ultrasound, chest x-ray and computed tomography
Intervention Type
Device
Intervention Name(s)
Chest X-ray
Intervention Description
All patients will receive chest x-ray as per usual care for evaluation for pneumonia
Intervention Type
Device
Intervention Name(s)
Chest Computed Tomography (CT)
Intervention Description
All enrolled patients will receive a CT scan as the gold standard for diagnosing pneumonia
Primary Outcome Measure Information:
Title
Diagnosis of Pneumonia
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bharat Yadav, MD
Organizational Affiliation
Chair of Department of Emergency Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21030550
Citation
Cortellaro F, Colombo S, Coen D, Duca PG. Lung ultrasound is an accurate diagnostic tool for the diagnosis of pneumonia in the emergency department. Emerg Med J. 2012 Jan;29(1):19-23. doi: 10.1136/emj.2010.101584. Epub 2010 Oct 28.
Results Reference
result
PubMed Identifier
18046031
Citation
Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
Results Reference
result
PubMed Identifier
24184011
Citation
Bourcier JE, Paquet J, Seinger M, Gallard E, Redonnet JP, Cheddadi F, Garnier D, Bourgeois JM, Geeraerts T. Performance comparison of lung ultrasound and chest x-ray for the diagnosis of pneumonia in the ED. Am J Emerg Med. 2014 Feb;32(2):115-8. doi: 10.1016/j.ajem.2013.10.003. Epub 2013 Oct 9.
Results Reference
result
PubMed Identifier
19365166
Citation
Hagaman JT, Rouan GW, Shipley RT, Panos RJ. Admission chest radiograph lacks sensitivity in the diagnosis of community-acquired pneumonia. Am J Med Sci. 2009 Apr;337(4):236-40. doi: 10.1097/MAJ.0b013e31818ad805.
Results Reference
result
PubMed Identifier
25142033
Citation
Liu XL, Lian R, Tao YK, Gu CD, Zhang GQ. Lung ultrasonography: an effective way to diagnose community-acquired pneumonia. Emerg Med J. 2015 Jun;32(6):433-8. doi: 10.1136/emermed-2013-203039. Epub 2014 Aug 20.
Results Reference
result
PubMed Identifier
22700780
Citation
Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.
Results Reference
result
PubMed Identifier
22726366
Citation
Reissig A, Gramegna A, Aliberti S. The role of lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia. Eur J Intern Med. 2012 Jul;23(5):391-7. doi: 10.1016/j.ejim.2012.01.003. Epub 2012 Feb 21.
Results Reference
result
PubMed Identifier
9709887
Citation
Syrjala H, Broas M, Suramo I, Ojala A, Lahde S. High-resolution computed tomography for the diagnosis of community-acquired pneumonia. Clin Infect Dis. 1998 Aug;27(2):358-63. doi: 10.1086/514675.
Results Reference
result
PubMed Identifier
29527652
Citation
Amatya Y, Rupp J, Russell FM, Saunders J, Bales B, House DR. Diagnostic use of lung ultrasound compared to chest radiograph for suspected pneumonia in a resource-limited setting. Int J Emerg Med. 2018 Mar 12;11(1):8. doi: 10.1186/s12245-018-0170-2.
Results Reference
derived
Learn more about this trial
Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal
We'll reach out to this number within 24 hrs