Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
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|ClinicalTrials.gov Identifier: NCT01655329|
Recruitment Status : Completed
First Posted : August 1, 2012
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
|Condition or disease|
|Catheters, With or Without Malposition Image Interpretation, Computer Assisted|
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)
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Observational Model:||Case Control|
|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.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||February 2013|
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
- Time for Completion of Tasks [ Time Frame: 8 hours ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|