Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 5 point likert scale to evaluate the "level of confidence" of each radiologist
研究概览
简要总结
The ULTRACHEST study will be a prospective clinical diagnostic performance study with primary objective to establish device diagnostic clinical performance of Ultra Low Dose CT (ULD-CT) in order to prove it is more accurate in detecting pneumonia when comparing to standard conventional chest radiography.
详细描述
- 200 subjects
- Each subject will undergo CXR and ULD-CT at the same day.
- Subjects subdivided into 3 groups [high, moderate and low risk], based on a laboratory finding(CRP), symptoms and physical examination.
- 3 different thoracic radiologist will judge the scans on existence of consolidation. Consolidation will be expressed as binary outcomes (Yes or No consolidation)
- Radiologist will be blinded for subjects demographic data.
- All radiologist have to score how confidence they were on the finding of consolidation[5point likert].
- The investigators will perform a McNemar's test for evaluation. A two sided p-value of less than 0.05 will be considered to be statistically significant.
- Inter-observer variability will be evaluated by using a Fleiss Kappa test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suffering from pneumonia and referred by their GP
排除标准
- •Younger than 18
- •Known pregnancy
- •Not able to sign the Informed Consent document
- •If not willing to be informed about additional findings
研究组 & 干预措施
Subjects suffering from pneumonia
CXR ULD-CT
干预措施: ULD-CT (Radiation)
Subjects suffering from pneumonia
CXR ULD-CT
干预措施: CXR (Radiation)
结局指标
主要结局
5 point likert scale to evaluate the "level of confidence" of each radiologist
时间窗: 2 year
- As described in "outcome 1" the radiologist judges the scans on existence of consolidation. After each judgement the radiologists has to fill in a questionaire \[5 point likert scale\] to score their level of confidence on the finding on whether or not they saw consolidation on the scan.
Risk assessment of having a pneumonia for each subject
时间窗: 2 year
Subjects will be subdivided into 3 groups \[high, moderate and low risk\], based on a laboratory finding(CRP). * CRP levels lower than 20mg/L \> low risk * CRP levels between 20 and 100mg/l \> medium risk * CRP levels higher than 100mg/l \> high risk
Three different radiologists will be asked to fill in a questionaire on whether or not there is presence of consolidation (yes/no) on both ULD-CT, as well as on CXR.
时间窗: 2 years
* 3 different thoracic radiologist will judge the scans on existence of consolidation. Consolidation will be expressed as binary outcomes (Yes or No consolidation) * Radiologist will be blinded for subjects demographic data.
次要结局
- Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires(2 year)
- In case the radiologist observes an additional finding, the radiologist has to fill in a questionaire on paper what kind of additional finding was seen:(2 year)
- All 3 radiologist will be asked to write down on paper if they see an additional finding on either the ULD-CT or CXR(2 years)