Validity of Pleural Effusion Detection Software

• Conditions: Pleural Effusion
• Interventions: Device: Chang Gung Pleural Effusion Detection Software

• Registration Number: NCT05903287
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The Chang Gung Pleural Effusion Detection Software is a medical software that can automatically detect whether there is a pleural effusion in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pleural Effusion Detection Software can correctly identify patients with pleural effusion in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

Detailed Description

This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2018 to December 31, 2020. After confirming that the Chest X-Ray that meet the inclusion and exclusion criteria are correct, 282 samples will be sampled for this test, including 141 images with pleural effusion and 141 images without pleural effusion. The image must be in DICOM format.

Then, 3 specialists physicians interpret 282 samples whether there were pleural effusion, and the result was the standard of this study (Reference standard). After determining the reference standard of each Chest X-Ray, the 282 samples were input into the Chang Gung Pleural Effusion Detection Software, and analyzed by the primary and secondary outcomes.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Study Start: 2023-06-17
• Primary Completion: 2023-11-23
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Study Completion: 2024-08-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• The case were over 20 years old and under 100 years old.
• DICOM format.
• Brand model of Canon.
• DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
• poster-anterior view(PA-view) of chest X-ray

Exclusion Criteria

• The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
• The chest X-ray that are difficult to interpret due to poor image quality.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Software diagnosis	Chang Gung Pleural Effusion Detection Software	Software diagnosis with gold standard of 3 specialist physicians' interpretation.

Primary Outcome Measures

Name	Time	Method
Sensitivity	baseline	The rate of test results that correctly indicate the presence.

Secondary Outcome Measures

Name	Time	Method
Specificity	baseline	The rate of test results that correctly indicate the absence.
Area Under the receiver operating characteristic Curve	baseline	A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.

Trial Locations

Locations (1)

Chang Gung memorial hospital; 🇨🇳 Taoyuan City, Taiwan