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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects suffering from pneumonia | Experimental | CXR ULD-CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ULD-CT | Radiation | Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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).
| 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. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Das, Dr | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUMC | Maastricht | Limburg | 6229HX | Netherlands |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| CXR | Radiation | Conventional chest radiograph |
|
|
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. |
| 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:
Number of subjects with additional finding of tumoral mass:
Number of subjects with additional finding of pleural effusion:
| 2 year |