Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia

Completed

• Conditions: Pneumonia

• Registration Number: NCT00808457
• Lead Sponsor: University of Jena

Brief Summary

The study of a large number of patients (at least 200 patients) from several European centres aims to investigate the value of chest ultrasound in diagnosing and checking the course of pneumonia as compared to a chest X-ray film in two planes and - in case of a controversial X-ray finding- as compared to low-dose CT.

An X-ray finding is regarded controversial, if infiltrates cannot be reliably excluded or not reliably represented and if a definite diagnosis is, thus, not possible. A low-dose CT is indicated even in case of a positive chest ultrasound and negative X-ray finding. Sonographic recording and characterization of pneumonic infiltrates is performed both at the time of diagnosing and in the further course under therapy.

Detailed Description

The primary target criterion is

• Assessing the sensitivity of chest ultrasound in diagnosing pneumonia.

Secondary target criteria comprise

* Assessing specificity, negative and positive predictive value of chest ultrasound at the time of diagnosing,

* Characterizing pneumonic infiltrates at the time of diagnosing and further course,

* Describing the association between clinical, X-ray and sonographic findings in the course of pneumonia.

The tertiary target criterion includes

• Characterizing the range of pathogens detected by microbiological examination.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-12
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

Patients with clinically suspected CAP who received no antibiotic treatment yet

• Patients in whom a chest X-ray in 2 planes was already performed, can be included in the study, if chest ultrasound is performed within 24 hours after X-ray and if the X-ray finding is neither available to nor known to the examiner doing the ultrasound examination.
• Age > 18 years
• Patient's declaration of consent is available.

Exclusion Criteria

• Patients with HAP
• Age <18 years
• Patients in whom the time difference between chest ultrasound and chest X-ray in 2 planes is more than 24 hours
• Patients whose X-ray findings are with the examiner doing the ultrasound or are known to him
• Pregnancy and lactation
• Missing declaration of consent by the patient.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity of chest ultrasound in diagnosing pneumonia	baseline diagnostic

Secondary Outcome Measures

Name	Time	Method
Specificity	baseline diagnostic

Trial Locations

Locations (1)

Pneumology, Friedrich-Schiller University Jena; 🇩🇪 Jena, Thüringen, Germany