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- Klinische proef NCT07687628
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula (CBESB)
1 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
60
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Stefano Mariconti, MD
- Telefoonnummer: +39 035.267.5150/49
- E-mail: smariconti@asst-pg23.it
Studie Locaties
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Italy
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Bergamo, Italy, Italië, 24100
- Werving
- Sc Ricerca Clinica, Sviluppo E Innovazione
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Contact:
- Monia Lorini, Director
- Telefoonnummer: +39-035-2673341/4432
- E-mail: mlorini@asst-pg23.it
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Diagnostic success rate of preoperative tracheoscopy
Tijdsspanne: 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)
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Intraoperative (at the time of the preoperative tracheoscopy procedure)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of anesthetic complications
Tijdsspanne: Intraoperative
|
Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
|
Intraoperative
|
|
Learning curve of each tracheoscopy technique
Tijdsspanne: 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
Tijdsspanne: Perioperative (at initiation of the surgical procedure)
|
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
Tijdsspanne: Baseline (immediately before tracheoscopy)
|
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
Tijdsspanne: 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
Tijdsspanne: 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
|
At conclusion of the surgical procedure (up to 30 minutes)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of gastric distension at end of surgery
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Ezio Bonanomi, MD, A.O. Ospedale Papa Giovanni XXIII
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2024
Primaire voltooiing (Geschat)
31 januari 2029
Studie voltooiing (Geschat)
31 januari 2031
Studieregistratiedata
Eerst ingediend
26 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juli 2026
Eerst geplaatst (Werkelijk)
7 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
1 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische aandoeningen, anatomisch
- Ziekten van de luchtwegen
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Slokdarmaandoeningen
- Spijsverteringsstelsel fistel
- Fistel
- Tracheale aandoeningen
- Fistel van de luchtwegen
- Slokdarm fistel
- Pathologische aandoeningen, tekenen en symptomen
- Tracheo-oesofageale fistel
- Slokdarmatresie met of zonder tracheosphageale fistel
Andere studie-ID-nummers
- VideoendoFTE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .