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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tracheoscopy performed with rigid optical tracheoscopy | Procedure | Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation |
| 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) |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Mariconti, MD | Contact | +39 035.267.5150/49 | smariconti@asst-pg23.it |
| Name | Affiliation | Role |
|---|---|---|
| Ezio Bonanomi, MD | A.O. Ospedale Papa Giovanni XXIII | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sc Ricerca Clinica, Sviluppo E Innovazione | Recruiting | Bergamo | Italy | 24100 | Italy |
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| flexible video endoscopy of trachea | Device | Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates |
|
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) |
| ID | Term |
|---|---|
| D014138 | Tracheoesophageal Fistula |
| C531835 | Esophageal atresia with or without tracheoesophageal fistula |
| ID | Term |
|---|---|
| D004937 | Esophageal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D016156 | Respiratory Tract Fistula |
| D012140 | Respiratory Tract Diseases |
| D014133 | Tracheal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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