Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02949141
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2016-10-25
Brief Title:
Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal
Sponsor:
Patan Academy of Health Sciences
Organization:
Patan Academy of Health Sciences
Study Overview
Official Title:
Diagnostic Use of Lung Ultrasound Compared to Chest X-Ray for Suspected Pneumonia in Nepal
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Hospitals 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 32000 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 06 we will review lung ultrasound with these investigators and repeat above evaluation until kappa of 06 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 McNemars test will be used to evaluate any statistical difference in sensitivity between CXR and US
Study Setting Located in the Kathmandu valley Patan Hospital is a large urban hospital with 35-bed Emergency Department that sees approximately 32000 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 06 we will review lung ultrasound with these investigators and repeat above evaluation until kappa of 06 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 McNemars test will be used to evaluate any statistical difference in sensitivity between CXR and US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None