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NCT Number: NCT01655329

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

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.

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Key information

Conditions

Catheters, With or Without Malposition Image Interpretation, Computer Assisted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave

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

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Riverain Technologies

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Aug 1, 2012
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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