- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07687628
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula (CBESB)
1. juli 2026 opdateret af: Stefano Mariconti, Papa Giovanni XXIII Hospital
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
Tracheoesophageal fistula, with or without esophageal atresia, is a rare congenital malformation which may be included in a wider spectrum of congenital abnormalities (VACTERL: vertebral, anorectal, cardiac, tracheoesophageal, renal and limb abnormalities).
This condition presents challenging airway management due to the risk of gastric distension during positive pressure ventilation.
ERNICA guidelines suggest that a tracheoscopy should be routinely performed preoperatively to evaluate the fistula position, rule out a double fistula, and identify other tracheal pathology; however, the optimal setting and approach remains controversial.
Rigid tracheoscopy, performed in paralyzed neonates, can provide superior visualization of the trachea, but with a risk of gastric distension; moreover, the learning curve is steep.
Flexible tracheoscopy using conventional fiberoptic bronchoscopes could allow maintenance of spontaneous breathing, but image quality is poor.
New-generation disposable video-endoscopes come equipped with a miniaturized camera that replaces traditional fiberoptic technology, enabling enhanced visualization.
The goal of this observational ambispective study is to compare the outcomes of two different airway management approaches in neonates and infants undergoing congenital tracheoesophageal fistula repair: rigid tracheoscopy with flexible video-endoscopy.
The main questions the investigators aim to answer are: Is the tracheal flexible video-endoscopy performed in spontaneously breathing neonates effective, regarding optimal tracheal visualization and therefore for accurate diagnosis?
Does it allow the successful detection and eventually rigid wire cannulation of the fistula?
Are there differences between the two approaches, regarding the procedure length, or the incidence of complications (desaturation, gastric distension, respiratory depression, major cardiopulmonary complications)?
Do the two approaches differ in learning curve shape?
The investigators will compare a historical cohort of neonates who underwent rigid tracheoscopy with positive pressure ventilation, with a prospective group of neonates that will receive spontaneous breathing flexible tracheoscopy.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Stefano Mariconti, MD
- Telefonnummer: +39 035.267.5150/49
- E-mail: smariconti@asst-pg23.it
Studiesteder
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Italy
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Bergamo, Italy, Italien, 24100
- Rekruttering
- Sc Ricerca Clinica, Sviluppo E Innovazione
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Kontakt:
- Monia Lorini, Director
- Telefonnummer: +39-035-2673341/4432
- E-mail: mlorini@asst-pg23.it
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Consecutive neonates undergoing surgical repair of esophageal atresia with or without tracheoesophageal fistula at a single tertiary pediatric center (ASST Papa Giovanni XXIII, Bergamo, Italy).
The retrospective cohort includes patients treated from January 2013; the prospective cohort includes patients enrolled from October 2024 onward.
Beskrivelse
Inclusion Criteria:
- Neonates who have undergone surgical repair of esophageal atresia with or without tracheoesophageal fistula at ASST Papa Giovanni XXIII, Bergamo, from 1 January 2013 onwards
- Written informed consent signed by both parents or legal guardian
Exclusion Criteria:
- Refusal or inability to obtain informed consent from parents or legal guardian
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
flexible video-endoscopy
Neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment is performed by flexible video-endoscopy (Ambu aScope 5 Broncho 2.7/1.2) under deep sedation with maintenance of spontaneous breathing and topical anesthesia of the upper airways and vocal cords.
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Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
|
|
rigid tracheoscopy
All neonates who underwent surgical repair of tracheoesophageal fistula from January 2013 to September 2024, plus neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment was performed by rigid optical tracheoscopy under general anesthesia with positive pressure ventilation.
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Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic success rate of preoperative tracheoscopy
Tidsramme: Intraoperative (at the time of the preoperative tracheoscopy procedure)
|
Percentage of procedures in which the technique allowed correct visualization of the tracheoesophageal fistula, including identification of secondary fistulas, out of total procedures performed with each method (rigid vs flexible bronchoscopy)
|
Intraoperative (at the time of the preoperative tracheoscopy procedure)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of anesthetic complications
Tidsramme: Intraoperative
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Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
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Intraoperative
|
|
Learning curve of each tracheoscopy technique
Tidsramme: From the first procedure to the achievement of autonomous competence with each technique, assessed over the total study duration (up to 5 years)
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Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy
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From the first procedure to the achievement of autonomous competence with each technique, assessed over the total study duration (up to 5 years)
|
|
Gastric distension
Tidsramme: Perioperative (at initiation of the surgical procedure)
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Presence of gastric distension (yes/no) at the beginning of the surgical phase
|
Perioperative (at initiation of the surgical procedure)
|
|
Arterial blood gas values at baseline
Tidsramme: Baseline (immediately before tracheoscopy)
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Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at baseline (prior to tracheoscopy)
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Baseline (immediately before tracheoscopy)
|
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Arterial blood gas values at beginning of surgery
Tidsramme: Perioperative (at initiation of the surgical procedure)
|
Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at beginning of the surgical procedure
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Perioperative (at initiation of the surgical procedure)
|
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Arterial blood gas values at end of surgery
Tidsramme: At conclusion of the surgical procedure (up to 30 minutes)
|
Description: Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at conclusion of the surgical procedure
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At conclusion of the surgical procedure (up to 30 minutes)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of gastric distension at end of surgery
Tidsramme: At conclusion of the surgical procedure (up to 30 minutes)
|
Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure
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At conclusion of the surgical procedure (up to 30 minutes)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Ezio Bonanomi, MD, A.O. Ospedale Papa Giovanni XXIII
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2024
Primær færdiggørelse (Anslået)
31. januar 2029
Studieafslutning (Anslået)
31. januar 2031
Datoer for studieregistrering
Først indsendt
26. juni 2026
Først indsendt, der opfyldte QC-kriterier
1. juli 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske Tilstande, Anatomiske
- Luftvejssygdomme
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Esophageale sygdomme
- Fistel i fordøjelsessystemet
- Fistel
- Trakeale sygdomme
- Luftvejsfistel
- Esophageal fistel
- Patologiske tilstande, tegn og symptomer
- Trakeøsofageal fistel
- Esophageal atresia med eller uden tracheoesophageal fistel
Andre undersøgelses-id-numre
- VideoendoFTE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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