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

NCT01655329 | Completed Results

• 1 other identifier: MF 2012-1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Image Processing; tubes; lines; catheters; wires; Bedside; chest; radiographs

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Likert-Like

  10 minutes

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• For radiologists: Not in active practice. Working in a university hospital.
• For cases: children. Do not meet image quality criteria.

Sponsors & Collaborators

• Georgetown University: lead
• Riverain Technologies: collaborator

Study Sites (1)

Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave

Washington D.C., District of Columbia, 20007, United States

Location

Results Point of Contact

• Title: Matthew T. Freedman
• Organization: Georgetown University Medical Center

MTFreedman@verizon.net

4105429680

Study Officials

• Matthew T Freedman, MD, MBA

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Shih-Chung Ben Lo, Ph.D.

  Georgetown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Oncology

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 10, 2014
• Results First Posted: July 10, 2014

Record last verified: 2014-06

Locations

US (1)