Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
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.
Catheters, With or Without Malposition
Image Interpretation, Computer Assisted
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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.|
- Time for Completion of Tasks [ Time Frame: 8 hours ] [ Designated as safety issue: No ]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.
- Accuracy in Detecting the Tips of Tubes, Lines, and Wires. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]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.
- Likert-Like [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image.
|Study Start Date:||August 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Standard chest radiographs
The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs.
Modified chest radiographs
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
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655329
|United States, District of Columbia|
|Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave|
|Washington,, District of Columbia, United States, 20007|
|Principal Investigator:||Matthew T Freedman, MD, MBA||Georgetown University|
|Study Director:||Shih-Chung Ben Lo, Ph.D.||Georgetown University|