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

Pneumonia Clinical Trial

Official title:

Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia. Prospective Comparison Between X-ray Chest Film in Two Planes and "Low-dose" Spiral Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808457
• Other study ID #: 2055-06/07
• Secondary ID: PD Dr. med. Ange
• Status: Completed
• Phase: N/A
• First received: December 12, 2008
• Last updated: August 12, 2011
• Start date: September 2007
• Est. completion date: February 2011

Study information

• Verified date: August 2011
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionAustria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia

Locations

Country	Name	City	State
Germany	Pneumology, Friedrich-Schiller University Jena	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian. — View Citation

Reissig A, Kroegel C. Sonographic diagnosis and follow-up of pneumonia: a prospective study. Respiration. 2007;74(5):537-47. Epub 2007 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of chest ultrasound in diagnosing pneumonia		baseline diagnostic	No
Secondary	Specificity		baseline diagnostic	No