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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
MUMC
Maastricht, Limburg, Netherlands
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.
* 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.
Time frame: 2 years
Risk assessment of having a pneumonia for each subject
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
Time frame: 2 year
5 point likert scale to evaluate the "level of confidence" of each radiologist
\- 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.
Time frame: 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
Three different thoracic radiologist will judge the scans and fill in a questionaire if they see any additional finding (Yes/No).
Time frame: 2 years
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:
In case they see an additional finding, they have to fill in what kind of additional finding the have seen and write it down in the questionaire. Example: \[tumoral mass; pleural effusion; atelectasis; lymph nodules\]. \- Additional findings will be subdivided in: atelectasis, pleural effusion, tree in bud, lymph nodes or tumoral mass.
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Time frame: 2 year
Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires
All additional findings will be presented in a table. for example: Number of subjects with additional finding of atelectasis: * ULD-CT (40 ULD-CT scans with atelectasis out of 100) * CXR (25 CXR radiographs with atelectasis out of 100) Number of subjects with additional finding of tumoral mass: * ULD-CT (2 ULD-CT scans with tumoral mass out of 100) * CXR (1 CXR radiographs with tumoral mass out of 100) Number of subjects with additional finding of pleural effusion: * ULD-CT (15 ULD-CT scans with pleural effusion out of 100) * CXR (33 CXR radiographs with pleural effusion out of 100)
Time frame: 2 year