Catheters, With or Without Malposition, Image Interpretation, Computer Assisted
Conditions
Keywords
Image Processing, tubes, lines, catheters, wires, Bedside, chest, radiographs
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)
Interventions
None listed
Sponsors
Riverain Technologies
Georgetown University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for Completion of Tasks | 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. |
| Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | 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
| Measure | Time frame | Description |
|---|---|---|
| Likert-Like | 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. |
Countries
United States
Participant flow
Recruitment details
Ten Board Certified radiologists practicing in community (non-university) practice were recruited from the Washington, DC, - Baltimore, MD, Metropolitan region. Recruitment was by email and phone calls to prior participants in our studies and to other radiologists that they referred us to. Recruitment April, 2012 through September, 2012
Pre-assignment details
54 cases were used to train the radiologists on the use of the data recording computer and to make them familiar with the appearance of the processed chest radiographs. These cases were not used in the test of reader performance.
Participants by arm
| Arm | Count |
|---|---|
| Radiologists Board Certified Radiologists | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Radiologists |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex/Gender, Customized female | 3 participants |
| Sex/Gender, Customized male | 7 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 8 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Chest Radiographs | Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | NG tubes distance in centimeters vs experts | 3.62 centimeters | Standard Error 0.79 |
| Standard Chest Radiographs | Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | Venous catheters distance in centimeters | 3.49 centimeters | Standard Error 0.52 |
| Modified Chest Radiographs | Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | NG tubes distance in centimeters vs experts | 3.96 centimeters | Standard Error 0.78 |
| Modified Chest Radiographs | Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | Venous catheters distance in centimeters | 3.14 centimeters | Standard Error 0.52 |
Primary
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.
Time frame: 8 hours
Population: Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Chest Radiographs | Time for Completion of Tasks | 27.68 seconds | Standard Error 3.32 |
| Modified Chest Radiographs | Time for Completion of Tasks | 22.90 seconds | Standard Error 3.32 |
Other Pre-specified
Likert-Like
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.
Time frame: 10 minutes
Population: All 10 radiologist participants participated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Chest Radiographs | Likert-Like | 3.9 units on a scale | Standard Deviation 0.99 |
| Modified Chest Radiographs | Likert-Like | 2.4 units on a scale | Standard Deviation 0.97 |
| Venous Catheters | Likert-Like | 4.5 units on a scale | Standard Deviation 0.71 |
| Cardiac Related Wires | Likert-Like | 2.7 units on a scale | Standard Deviation 1.34 |
| Overall Image Quality | Likert-Like | 2.5 units on a scale | Standard Deviation 1.08 |
| Image Quality Radioopaque Regions | Likert-Like | 2.9 units on a scale | Standard Deviation 1.29 |
| Confidence on Line Placement | Likert-Like | 4.1 units on a scale | Standard Deviation 1.29 |
| Need for Window/Level Manipulation | Likert-Like | 1.6 units on a scale | Standard Deviation 1.26 |
| Confidence on Tube Placement | Likert-Like | 4.4 units on a scale | Standard Deviation 0.7 |