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The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax 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.
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, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format.
Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Software diagnosis | Software diagnosis with gold standard of 3 doctors' interpretation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chang Gung Pneumothorax Detection Software | Device | The Chang Gung Pneumothorax Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pneumothorax. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pneumothorax. This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The rate of test results that correctly indicate the presence. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The rate of test results that correctly indicate the absence. | baseline |
| Area Under the receiver operating characteristic Curve | A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, Chest X-ray data from the database during 2006.01.01~2020.12.31 was collected.
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Fu Kuo | Associate Professor and Director Division of Rheumatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung memorial hospital | Taoyuan City | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25852759 | Background | Ebrahimi A, Yousefifard M, Mohammad Kazemi H, Rasouli HR, Asady H, Moghadas Jafari A, Hosseini M. Diagnostic Accuracy of Chest Ultrasonography versus Chest Radiography for Identification of Pneumothorax: A Systematic Review and Meta-Analysis. Tanaffos. 2014;13(4):29-40. | |
| 21679560 | Background | Nagarsheth K, Kurek S. Ultrasound detection of pneumothorax compared with chest X-ray and computed tomography scan. Am Surg. 2011 Apr;77(4):480-4. |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| baseline |
| 20149371 | Background | Nandipati KC, Allamaneni S, Kakarla R, Wong A, Richards N, Satterfield J, Turner JW, Sung KJ. Extended focused assessment with sonography for trauma (EFAST) in the diagnosis of pneumothorax: experience at a community based level I trauma center. Injury. 2011 May;42(5):511-4. doi: 10.1016/j.injury.2010.01.105. Epub 2010 Feb 10. |
| 3203523 | Background | Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):312-26. doi: 10.1016/0197-2456(88)90046-3. |
| 21772732 | Background | Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352. |
| 30929415 | Background | Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1. |