Pneumonia
Conditions
Brief summary
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.
Detailed description
* 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.
Interventions
RADIATIONULD-CT
Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
RADIATIONCXR
Conventional chest radiograph
Sponsors
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Suffering from pneumonia and referred by their GP
Exclusion criteria
* Younger than 18 * Known pregnancy * Not able to sign the Informed Consent document * If not willing to be informed about additional findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Risk assessment of having a pneumonia for each subject | 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 |
| 5 point likert scale to evaluate the level of confidence of each radiologist | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Three different thoracic radiologist will judge the scans and fill in a questionaire if they see any additional finding (Yes/No). |
| 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 | 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. |
| Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires | 2 year | 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) |
Countries
Netherlands
Outcome results
None listed