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Comparing Flexible Video-Endoscopy and Rigid Tracheoscopy for Airway Assessment in Newborns with Tracheoesophageal Fistula
Led by Papa Giovanni XXIII Hospital · Updated on 2026-07-07
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare two methods of airway assessment in newborns with tracheoesophageal fistula before surgery rigid tracheoscopy and flexible video-endoscopy. The study focuses on whether flexible video-endoscopy performed while the baby breathes spontaneously offers effective tracheal visualization and accurate diagnosis. It also examines differences in procedure length, complication rates, and the learning curve between these two approaches. The study involves two groups of neonates. One group includes babies undergoing flexible video-endoscopy under sedation while maintaining spontaneous breathing, using a new disposable video-endoscope. The other group includes a historical cohort who had rigid tracheoscopy with general anesthesia and positive pressure ventilation. The flexible video-endoscopy aims to provide enhanced visualization without the risks associated with positive pressure ventilation. Participants will be evaluated through their preoperative airway assessments, with researchers monitoring diagnostic success, anesthetic complications, gastric distension, and arterial blood gas values at multiple time points. The learning curve for each technique will also be assessed over up to five years. The study spans from October 2024 to January 2031, involving neonates up to 28 days old who had surgical repair of the fistula.
CONDITIONS
Brief Title
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Research Team
S
Stefano Mariconti, MD
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