Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal

NCT02949141 | Completed Results

• 1 other identifier: Pahs
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Study Arms (1)

Ultrasound

EXPERIMENTAL

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)

Interventions

Lung Ultrasound DEVICE

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

Ultrasound

Chest X-ray DEVICE

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

Ultrasound

Chest Computed Tomography (CT) DEVICE

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

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Children will be excluded from the study. Also, ultrasound studies completed by physicians not trained in lung ultrasound will not be included.

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead
• Vanderbilt University: collaborator
• Indiana University School of Medicine: collaborator

Related Publications (9)

• 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.

  PMID: 21030550 RESULT

• 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.

  PMID: 18046031 RESULT

• 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.

  PMID: 24184011 RESULT

• 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.

  PMID: 19365166 RESULT

• 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.

  PMID: 25142033 RESULT

• 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.

  PMID: 22700780 RESULT

• 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.

  PMID: 22726366 RESULT

• 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.

  PMID: 9709887 RESULT

• 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.

  PMID: 29527652 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Darlene R House, MD
• Organization: Patan Academy of Health Science

dhouse@iupui.edu

+977 9810339799

Study Officials

• Bharat Yadav, MD

  Chair of Department of Emergency Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Emergency Medicine and Pediatrics

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 19, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share