Fleksibel bronkoskopi ved resistent pneumoni på børneintensiv (FFP-RP PICU)
Resultat af fleksibel fiberoptisk bronkoskopi-anvendelse hos børn med resistent lungebetændelse på børneintensivafdelinger (PICU)
Lungebetændelse er en af de mest almindelige og alvorlige infektioner hos børn, især dem der er indlagt på Børneintensivafdelinger (PICU'er). Nogle børn forbedrer sig ikke efter mindst fem dages passende bredspektret antibiotikabehandling. Denne tilstand er kendt som resistent eller ikke-opløsende lungebetændelse.
Fleksibel fiberoptisk bronkoskopi (FFB) er en procedure, der lægerne muliggør at direkte undersøve luftvejene og indsamle prøver fra lungerne til laboratorietestning. Denne undersøgelse har til formål at evaluere rollen og anvendeligheden af fleksibel bronkoskopi og bronchoalveolær lavage (BAL) i at identificere årsagerne til resistent lungebetændelse hos kritisk syge børn.
Undersøgelsen vil inkludere børn indlagt på PICU på Abu El-Reesh Børnehospital, Cairo Universitet, som ikke viser klinisk eller radiologisk forbedring efter fem dages første-linje antibiotikabehandling. Resultaterne af denne undersøgelse kan hjælpe med at forbedre diagnosen, guide målrettet behandling og forbedre resultaterne hos børn med resistent lungebetændelse.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Lower respiratory tract infections remain a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). Despite appropriate empirical antimicrobial therapy, some patients continue to demonstrate persistent clinical and radiological evidence of pneumonia after at least five days of broad-spectrum antibiotic treatment. These patients are considered to have resistant or non-resolving pneumonia and often require additional diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.
Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. In addition to identifying airway abnormalities such as mucus plugging, tracheobronchitis, foreign body aspiration, airway malacia, or extrinsic airway compression, BAL specimens can be analyzed by conventional culture and molecular diagnostic methods to facilitate targeted antimicrobial therapy.
This prospective observational study was conducted in the Pediatric Intensive Care Unit of Abu El-Reesh Children's Hospital, Faculty of Medicine, Cairo University. Children aged 3 months to 14 years with resistant pneumonia who failed to improve clinically or radiologically after at least five days of first-line broad-spectrum antibiotic therapy and underwent clinically indicated flexible fiberoptic bronchoscopy with BAL were enrolled.
Clinical characteristics, laboratory investigations, inflammatory biomarkers, radiological findings, bronchoscopic findings, BAL microbiological results, antimicrobial susceptibility patterns, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes were recorded and analyzed. The study evaluated the diagnostic yield and clinical utility of FFB with BAL, compared different microbiological diagnostic methods, assessed the impact of bronchoscopy on patient management, and evaluated clinical outcomes including inflammatory marker response, duration of oxygen therapy, length of PICU stay, and survival to PICU discharge.
The findings of this study contribute to understanding the diagnostic performance, safety, and clinical impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in the evaluation and management of resistant pneumonia in critically ill pediatric patients.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Cairo Governorate
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Cairo, Cairo Governorate, Egypten
- Abu Elreesh children hospital , faculty of medicine , cairo university
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- - Børn i alderen over 3 måneder og under 18 år.
- Indlagt på Børneintensiv Afdeling (PICU).
Svær lungebetændelse defineret som hoste eller åndedrætsbesvær med mindst én af følgende:
- Iltmætning < 90% på pulsoximetri
- Svær åndedrætsbesvær
- Generelle faresignaler (uførlighed til at drikke, sløvhed, kramper)
- Ingen klinisk eller radiologisk forbedring efter mindst fem dages førstehånds bredspektret antibiotikabehandling.
- Informert samtykke indhentet fra forælder eller værge.
Eksklusionskriterier:
- Alder under 3 måneder eller over 18 år.
- Absolut kontraindikation for fleksibel bronkoskopi (svær refraktær hypoksæmi, hemodynamisk ustabilitet, ukorrigeret blødningsforstyrrelse).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy
Children admitted to the Pediatric Intensive Care Unit (PICU) with resistant pneumonia who showed no clinical or radiological improvement after at least 5 days of broad-spectrum antibiotic therapy and underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation.
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Flexible fiberoptic bronchoscopy with bronchoalveolar lavage was performed in all enrolled children with resistant pneumonia as part of the diagnostic evaluation.
Bronchoscopy was used for direct airway visualization and bronchoalveolar lavage sample collection for microbiological analysis to guide subsequent clinical management.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia
Tidsramme: During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge
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Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia
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During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical improvement after flexible fiberoptic bronchoscopy
Tidsramme: 72 hours after bronchoscopy
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Clinical improvement assessed by changes in C-reactive protein (CRP), total leukocyte count (TLC), chest radiographic findings, and oxygen requirement after flexible fiberoptic bronchoscopy.
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72 hours after bronchoscopy
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Microbiological diagnostic performance of bronchoalveolar lavage
Tidsramme: Within 7 days after bronchoscopy
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Comparison of bronchoalveolar lavage microbiological findings with sputum culture, blood culture, and molecular testing for pathogen identification.
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Within 7 days after bronchoscopy
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Clinical outcomes following bronchoscopy
Tidsramme: From bronchoscopy until PICU discharge
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Duration of oxygen therapy, length of PICU stay, treatment modification based on bronchoscopy findings, and mortality.
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From bronchoscopy until PICU discharge
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Samarbejdspartnere og efterforskere
Sponsor
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
Andre undersøgelses-id-numre
- MD-207-2023
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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