- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04911244
Diagnostic Modalities for VAP Detection
Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Ventilator associated pneumonia (VAP) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources.
The diagnosis of VAP is subjected to considerable interobserver variability. The Centers for Disease Control and Prevention (CDC) definition of VAP uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of VAP is limited.
The clinical pulmonary infection score (CPIS) was developed to objectively diagnose VAP and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial .
Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. It has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (VAP). However, no scientific evidence is yet available on whether LUS reliably improves the diagnosis of VAP.
Quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for VAP diagnosis with a cut off value of 104 colony-forming unit/ml. However, microbiological cultures cannot guide the early clinical management of patients with a suspected VAP, as they need at least 24 hours for preliminary results. So, starting antibiotics remains a challenge. Moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all ICUs. Therefore, it can be replaced by tracheal aspirate microbiological samples.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.
who had:
- Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
Or new or extension of a radiological image with at least two of the following clinical criteria:
- Body temperature ≥ 38.5 ° C or <36 ° C.
- Leukocytes> 10 * 103 / ml or <4 * 103/ ml or > 10% immature cells (in the absence of other known causes).
- Purulent tracheal secretions.
- Hypoxemia with PaO2 <60 mmHg or a PaO2 / FiO2 <300.
Exclusion Criteria:
- Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
- Patients who are contraindicated for bronchoscopy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: VAP group
patients confirmed diagnosis of VAP with bronchoalveolar lavage
|
endobronchial sampling through bronchoscopy
Andre navne:
|
Eksperimentel: Non VAP group
patients confirmed not VAP with bronchoalveolar lavage
|
endobronchial sampling through bronchoscopy
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To detected diagnostic accuracy of chest ultrasound in VAP.
Tidsramme: 3 years
|
To identify sensitivity and specificity of chest ultrasound in VAP diagnosis
|
3 years
|
To detected diagnostic accuracy of protected endotracheal aspirate in VAP.
Tidsramme: 3 years
|
To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
|
3 years
|
To detected diagnostic accuracy of usual endotracheal aspirate in VAP.
Tidsramme: 3 years
|
To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
|
3 years
|
To detected diagnostic accuracy of chest X-ray in VAP.
Tidsramme: 3 years
|
To identify sensitivity and specificity of chest X-ray in VAP diagnosis
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
- Nair GB, Niederman MS. Ventilator-associated pneumonia: present understanding and ongoing debates. Intensive Care Med. 2015 Jan;41(1):34-48. doi: 10.1007/s00134-014-3564-5. Epub 2014 Nov 27.
- Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Infektioner
- Luftvejsinfektioner
- Luftvejssygdomme
- Lungesygdomme
- Sygdomsegenskaber
- Krydsinfektion
- Iatrogen sygdom
- Sundhedsrelateret lungebetændelse
- Lungebetændelse
- Lungebetændelse, Ventilator-Associated
- Molekylære mekanismer for farmakologisk virkning
- Chelaterende midler
- Sekvesteringsagenter
- Dimercaprol
Andre undersøgelses-id-numre
- VAP diagnosis
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Ventilator Associated Pneumonia
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University of MichiganNational Institutes of Health (NIH); National Center for Advancing Translational...AfsluttetVAP - Ventilator Associated PneumoniaForenede Stater
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Assiut UniversityIkke rekrutterer endnuVAP - Ventilator Associated Pneumonia
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Ain Shams UniversityAfsluttetVAP - Ventilator Associated PneumoniaEgypten
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Erasmus Medical CenterChiesi Farmaceutici S.p.A.AfsluttetVentilator Associated Pneumonia (VAP)Spanien, Holland
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Andrzej Frycz Modrzewski Krakow UniversityAfsluttetVAP - Ventilator Associated PneumoniaPolen
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ShionogiAfsluttetHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spanien, Forenede Stater, Belgien, Canada, Tjekkiet, Estland, Frankrig, Georgien, Tyskland, Ungarn, Japan, Letland, Filippinerne, Puerto Rico, Den Russiske Føderation, Serbien, Taiwan, Ukraine
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University Hospital, Clermont-FerrandAfsluttetKritisk pleje | Mekanisk ventilation | Tandbørstning | Ventilator Associated Pneumonia Prevention | MundplejeFrankrig
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University Medical Centre LjubljanaAfsluttetVedligeholdelse af Normoglykæmi | forekomsten af Ventilator Associated Pneumonia (VAP) | Behandlingsperiode på intensivafdelingenSlovenien
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Centre Hospitalier Universitaire de BesanconGlaxoSmithKline; French Society for Intensive Care; SmithKline BeechamAfsluttetPneumoni Ventilator Associated
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Denver Health and Hospital AuthorityAfsluttetTidlig Ventilator Associated PneumoniForenede Stater
Kliniske forsøg med bronchoalveolar lavage
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Liverpool University Hospitals NHS Foundation TrustLiverpool School of Tropical MedicineAfsluttetSund og raskDet Forenede Kongerige
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Masonic Cancer Center, University of MinnesotaAfsluttetCytokinfrigivelsessyndrom | Immun og mikrobiel rekonstitution | Systemisk viral infektion | Akut-graft-versus-host sygdom | Kronisk graft-versus-vært-sygdom | Tilbagevendende malignitet | Allogene relaterede donorer | Celleterapi/immunterapipatienterForenede Stater
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Andrew D. Luster, M.D.,Ph.D.National Institute of Allergy and Infectious Diseases (NIAID)AfsluttetAstma | AllergierForenede Stater