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Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula (CBESB)

1 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

60

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Stefano Mariconti, MD
  • Número de teléfono: +39 035.267.5150/49
  • Correo electrónico: smariconti@asst-pg23.it

Ubicaciones de estudio

    • Italy
      • Bergamo, Italy, Italia, 24100
        • Reclutamiento
        • Sc Ricerca Clinica, Sviluppo E Innovazione
        • Contacto:
          • Monia Lorini, Director
          • Número de teléfono: +39-035-2673341/4432
          • Correo electrónico: mlorini@asst-pg23.it

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diagnostic success rate of preoperative tracheoscopy
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of anesthetic complications
Periodo de tiempo: Intraoperative
Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
Intraoperative
Learning curve of each tracheoscopy technique
Periodo de tiempo: From the first procedure to the achievement of autonomous competence with each technique, assessed over the total study duration (up to 5 years)
Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy
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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (immediately before tracheoscopy)
Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at baseline (prior to tracheoscopy)
Baseline (immediately before tracheoscopy)
Arterial blood gas values at beginning of surgery
Periodo de tiempo: Perioperative (at initiation of the surgical procedure)
Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at beginning of the surgical procedure
Perioperative (at initiation of the surgical procedure)
Arterial blood gas values at end of surgery
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of gastric distension at end of surgery
Periodo de tiempo: At conclusion of the surgical procedure (up to 30 minutes)
Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure
At conclusion of the surgical procedure (up to 30 minutes)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Ezio Bonanomi, MD, A.O. Ospedale Papa Giovanni XXIII

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2024

Finalización primaria (Estimado)

31 de enero de 2029

Finalización del estudio (Estimado)

31 de enero de 2031

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

7 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • VideoendoFTE

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .