Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Observational
SUMMARY
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Sc Ricerca Clinica, Sviluppo E Innovazione
RECRUITING
Bergamo
Contact Information
Primary
Stefano Mariconti, MD
smariconti@asst-pg23.it
+39 035.267.5150/49
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2031-01-31
Participants
Target number of participants: 60
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Papa Giovanni XXIII Hospital