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

Georgetown University

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01655329

MF 2012-1

Details and patient eligibility

About

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.

Full 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)

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10 participants in 2 patient groups

Standard chest radiographs

Description:

The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs.

Modified chest radiographs

Description:

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