Pneumonia Clinical Trial
Official title:
Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
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.
- 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.
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