An observational study in Tracheoesophageal Fistula and Esophageal Atresia With Tracheo-esophageal Fistula, sponsored by Papa Giovanni XXIII Hospital. Recruiting at 1 site in Italy. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Papa Giovanni XXIII Hospital · Observational
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
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.
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.
Exclusion Criteria:
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
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
Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
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)
Time frame: Intraoperative (at the time of the preoperative tracheoscopy procedure)
Incidence of anesthetic complications
Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
Time frame: Intraoperative
Learning curve of each tracheoscopy technique
Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: At conclusion of the surgical procedure (up to 30 minutes)
Incidence of gastric distension at end of surgery
Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure
Time frame: At conclusion of the surgical procedure (up to 30 minutes)
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Tracheoesophageal Fistula
Papa Giovanni XXIII Hospital