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

The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.

Study Overview

• Status: Recruiting
• Conditions: Tracheoesophageal Fistula; Esophageal Atresia With Tracheo-esophageal Fistula
• Intervention / Treatment: Device: flexible video endoscopy of trachea; Procedure: tracheoscopy performed with rigid optical tracheoscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Stefano Mariconti, MD; Phone Number: +39 035.267.5150/49; Email: smariconti@asst-pg23.it

Study Locations

• Italy
  • Italy
    • Bergamo, Italy, Italy, 24100
      • Recruiting
      • Sc Ricerca Clinica, Sviluppo E Innovazione
      • Contact: Monia Lorini, Director; Phone Number: +39-035-2673341/4432; Email: mlorini@asst-pg23.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: flexible video endoscopy of trachea; 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.	Procedure: tracheoscopy performed with rigid optical tracheoscopy; Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic success rate of preoperative tracheoscopy	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anesthetic complications	Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair	Intraoperative
Learning curve of each tracheoscopy technique	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	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	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	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	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gastric distension at end of surgery	Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure	At conclusion of the surgical procedure (up to 30 minutes)

Collaborators and Investigators

• Sponsor: Papa Giovanni XXIII Hospital
• Investigators: Study Chair: Ezio Bonanomi, MD, A.O. Ospedale Papa Giovanni XXIII

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2031

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: tracheoesophageal fistula
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Digestive System Fistula; Fistula; Tracheal Diseases; Respiratory Tract Fistula; Esophageal Fistula; Pathological Conditions, Signs and Symptoms; Tracheoesophageal Fistula; Esophageal atresia with or without tracheoesophageal fistula
• Other Study ID Numbers: VideoendoFTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No