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

This study has been completed.
Sponsor:
Collaborator:
Riverain Technologies, LLC, 3020 South Tech Boulevard,Miamisburg, OH 45342-4860
Information provided by (Responsible Party):
Matthew T. Freedman, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT01655329
First received: July 30, 2012
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


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

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655329

Locations
United States, District of Columbia
Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave
Washington,, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Riverain Technologies, LLC, 3020 South Tech Boulevard,Miamisburg, OH 45342-4860
Investigators
Principal Investigator: Matthew T Freedman, MD, MBA Georgetown University
Study Director: Shih-Chung Ben Lo, Ph.D. Georgetown University
  More Information

No publications provided

Responsible Party: Matthew T. Freedman, MD, Associate Professor Oncology, Georgetown University
ClinicalTrials.gov Identifier: NCT01655329     History of Changes
Other Study ID Numbers: MF 2012-1
Study First Received: July 30, 2012
Results First Received: February 2, 2014
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Image Processing
tubes
lines
catheters
wires
Bedside
chest
radiographs

ClinicalTrials.gov processed this record on October 19, 2014