Clinical trial NCT01655329: Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheters, With or Without Malposition
Image Interpretation, Computer Assisted
Keywords: Image Processing
tubes
lines
catheters
wires
Bedside
chest
radiographs
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Riverain Technologies
First posted: 2012-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Time for Completion of Tasks
timeFrame: 8 hours
measure: Accuracy in Detecting the Tips of Tubes, Lines, and Wires.
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
measure: Likert-Like
timeFrame: 10 minutes
Locations:
city: Washington,
country: United States
facility: Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Matthew T Freedman, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University
name: Shih-Chung Ben Lo, Ph.D.
role: STUDY_DIRECTOR
References: