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

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.

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington,, District of Columbia, United States, 20007
      • Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There are two populations: the radiologists and the cases they will review. For cases, these are sequential cases selected by database search using defined search criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert-Like	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.	10 minutes

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Riverain Technologies
• Investigators: Principal Investigator: Matthew T Freedman, MD, MBA, Georgetown University; Study Director: Shih-Chung Ben Lo, Ph.D., Georgetown University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: June 9, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: chest; Image Processing; Bedside; lines; radiographs; catheters; tubes; wires
• Other Study ID Numbers: MF 2012-1