NCT03140163

Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]

Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumonia

Interventions

Type	Name	Description
RADIATION	ULD-CT	Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
RADIATION	CXR	Conventional chest radiograph

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-04-01
• Completion: 2019-12-01
• First posted: 2017-05-04
• Last updated: 2018-11-20

Locations

1 site across 1 country: Netherlands