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- Klinische proef NCT00808457
Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia
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
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Thüringen
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Jena, Thüringen, Duitsland, 07740
- Pneumology, Friedrich-Schiller University Jena
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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patients with suspected pneumonia
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
sensitivity of chest ultrasound in diagnosing pneumonia
Tijdsspanne: baseline diagnostic
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baseline diagnostic
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Specificity
Tijdsspanne: baseline diagnostic
|
baseline diagnostic
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
- Reissig A, Kroegel C. Sonographic diagnosis and follow-up of pneumonia: a prospective study. Respiration. 2007;74(5):537-47. doi: 10.1159/000100427. Epub 2007 Feb 27.
- Reissig A, Mempel C, Schumacher U, Copetti R, Gross F, Aliberti S. Microbiological diagnosis and antibiotic therapy in patients with community-acquired pneumonia and acute COPD exacerbation in daily clinical practice: comparison to current guidelines. Lung. 2013 Jun;191(3):239-46. doi: 10.1007/s00408-013-9460-x. Epub 2013 Apr 6.
- Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2055-06/07
- PD Dr. med. Angelika Reißig
- Phone: 00493641/ 9-32 41 28
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