A Study to Evaluate Chang Gung Pneumothorax Detection Software

Pneumothorax Clinical Trial

Official title:

A Study to Evaluate Accuracy and Validity of Chang Gung Pneumothorax Detection Software Compared With Reference by Qualified Physicians

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05903209
• Other study ID #: 202200871B0
• Status: Enrolling by invitation
• Start date: June 13, 2022
• Est. completion date: January 12, 2024

Study information

• Verified date: May 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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, 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 344
• Est. completion date: January 12, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Device:
• Chang Gung Pneumothorax Detection Software
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung memorial hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Erratum In: Korean J Anesthesiol. 2019 Aug;72(4):396. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	The rate of test results that correctly indicate the presence.	baseline
Secondary	Specificity	The rate of test results that correctly indicate the absence.	baseline
Secondary	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.	baseline