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

Completed

• Conditions: Image Interpretation, Computer Assisted; Catheters, With or Without Malposition

• Registration Number: NCT01655329
• Lead Sponsor: Georgetown University

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-07-31
• Study Start: 2012-08
• Study First Posted: 2012-08-01
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Results First Submitted: 2014-02-02
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Results First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for Completion of Tasks	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.	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.

Trial Locations

Locations (1)

Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave; 🇺🇸 Washington,, District of Columbia, United States