Esophageal Atresia With Tracheo-esophageal Fistula, Tracheoesophageal Fistula
Conditions
Keywords
tracheoesophageal fistula
Brief 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.
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
PROCEDUREtracheoscopy 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
DEVICEflexible video endoscopy of trachea
Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
Sponsors
Papa Giovanni XXIII Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic success rate of preoperative tracheoscopy | Intraoperative (at the time of the preoperative tracheoscopy procedure) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of anesthetic complications | Intraoperative | Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair |
| Learning curve of each tracheoscopy technique | From the first procedure to the achievement of autonomous competence with each technique, assessed over the total study duration (up to 5 years) | Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy |
| Gastric distension | Perioperative (at initiation of the surgical procedure) | Presence of gastric distension (yes/no) at the beginning of the surgical phase |
| Arterial blood gas values at baseline | Baseline (immediately before tracheoscopy) | Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at baseline (prior to tracheoscopy) |
| Arterial blood gas values at beginning of surgery | Perioperative (at initiation of the surgical procedure) | Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at beginning of the surgical procedure |
| Arterial blood gas values at end of surgery | At conclusion of the surgical procedure (up to 30 minutes) | Description: Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at conclusion of the surgical procedure |
Countries
Italy
Contacts
CONTACTStefano Mariconti, MD
STUDY_CHAIREzio Bonanomi, MD
A.O. Ospedale Papa Giovanni XXIII
Outcome results
None listed