Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal

NCT ID: NCT02949141

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-05-01

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.

Conditions

Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Lung Ultrasound

Intervention Type: DEVICE

All patients will receive lung ultrasound, chest x-ray and computed tomography

Chest X-ray

Intervention Type: DEVICE

All patients will receive chest x-ray as per usual care for evaluation for pneumonia

Chest Computed Tomography (CT)

Intervention Type: DEVICE

All enrolled patients will receive a CT scan as the gold standard for diagnosing pneumonia

Interventions

Lung Ultrasound

All patients will receive lung ultrasound, chest x-ray and computed tomography

Intervention Type: DEVICE

Chest X-ray

All patients will receive chest x-ray as per usual care for evaluation for pneumonia

Intervention Type: DEVICE

Chest Computed Tomography (CT)

All enrolled patients will receive a CT scan as the gold standard for diagnosing pneumonia

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

Patan Academy of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Darlene Rose House

Assistant Professor of Clinical Emergency Medicine and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bharat Yadav, MD

Role: STUDY_CHAIR

Chair of Department of Emergency Medicine

References

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.

Reference Type: RESULT

PMID: 21030550 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18046031 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24184011 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19365166 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25142033 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22700780 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22726366 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9709887 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29527652 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pahs

Identifier Type: -

Identifier Source: org_study_id