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Recruiting NCT07687628

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

Observational Tracheoesophageal Fistula Esophageal Atresia With Tracheo-esophageal Fistula

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tracheoscopy performed with rigid optical tracheoscopy, flexible video endoscopy of trachea.
Who it may be relevant to
Registry conditions: Tracheoesophageal Fistula, Esophageal Atresia With Tracheo-esophageal Fistula. Basic parameters: 0 Days — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • 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
  • Device flexible video endoscopy of trachea
    Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates

Primary outcome measures

  • Diagnostic success rate of preoperative tracheoscopy [Time frame: Intraoperative (at the time of the preoperative tracheoscopy procedure)]
Secondary outcome measures (6)
  • Incidence of anesthetic complications [Time frame: Intraoperative]
  • Learning curve of each tracheoscopy technique [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 [Time frame: Perioperative (at initiation of the surgical procedure)]
  • Arterial blood gas values at baseline [Time frame: Baseline (immediately before tracheoscopy)]
  • Arterial blood gas values at beginning of surgery [Time frame: Perioperative (at initiation of the surgical procedure)]
  • Arterial blood gas values at end of surgery [Time frame: At conclusion of the surgical procedure (up to 30 minutes)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Sc Ricerca Clinica, Sviluppo E Innovazione — Bergamo

Identifiers

NCT: NCT07687628 · VideoendoFTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗