Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image
2014年6月9日 更新者：Matthew T. Freedman, MD、Georgetown University
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.
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.
研究概览
详细说明
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)
研究类型
观察性的
注册 (实际的)
10
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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District of Columbia
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Washington,、District of Columbia、美国、20007
- Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Standard chest radiographs
The radiologists will be viewing two groups of chest images.
The first group are standard chest radiographs.
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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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time for Completion of Tasks
大体时间：8 hours
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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.
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8 hours
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Accuracy in Detecting the Tips of Tubes, Lines, and Wires.
大体时间：8 hours
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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.
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8 hours
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Likert-Like
大体时间：10 minutes
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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.
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10 minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Matthew T Freedman, MD, MBA、Georgetown University
- 研究主任：Shih-Chung Ben Lo, Ph.D.、Georgetown University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2012年7月30日
首先提交符合 QC 标准的
2012年7月31日
首次发布 (估计)
2012年8月1日
研究记录更新
最后更新发布 (估计)
2014年7月10日
上次提交的符合 QC 标准的更新
2014年6月9日
最后验证
2014年6月1日
更多信息
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