- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Thüringen
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Jena, Thüringen, Tyskland, 07740
- Pneumology, Friedrich-Schiller University Jena
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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patients with suspected pneumonia
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
sensitivity of chest ultrasound in diagnosing pneumonia
Tidsramme: baseline diagnostic
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baseline diagnostic
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Specificity
Tidsramme: baseline diagnostic
|
baseline diagnostic
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2055-06/07
- PD Dr. med. Angelika Reißig
- Phone: 00493641/ 9-32 41 28
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