Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image

Study Overview
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Brief Summary
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This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer. This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs. The primary interest is in the time used to interpret the radiograph. We will determine if there is any change in accuracy of detection.

Detailed Description
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Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis) Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)

Official Title
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Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image. AP Stands for Antero-Posterior. PA Stands for Postero-anterior.

Conditions
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Catheters, With or Without Malposition, Image Interpretation, Computer Assisted

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the radiologists, they must in in active practice of community radiology (non-university sites). For the cases, they must be patients who have a tube, line, or wire in their chest. A small number of completely normal bedside chest radiographs will be included. Exclusion Criteria: For radiologists: Not in active practice. Working in a university hospital. For cases: children. Do not meet image quality criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard chest radiographs<br>The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. | |
| Modified chest radiographs<br>This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Completion of Tasks | Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time. | 8 hours | 
| Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology. | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Image Processing, tubes, lines, catheters, wires, Bedside, chest, radiographs