Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
NCT ID: NCT03140163
Last Updated: 2018-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-09-30
2019-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Subjects suffering from pneumonia
CXR ULD-CT
ULD-CT
Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
CXR
Conventional chest radiograph
Interventions
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ULD-CT
Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
CXR
Conventional chest radiograph
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known pregnancy
* Not able to sign the Informed Consent document
* If not willing to be informed about additional findings
18 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marco Das, Dr
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Locations
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MUMC
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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METC161004
Identifier Type: -
Identifier Source: org_study_id
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