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NCT Number: NCT07687628

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

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

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Sc Ricerca Clinica, Sviluppo E Innovazione

Bergamo, Italy, 24100

Location status: Recruiting

Location contact

Monia Lorini, Director

CONTACT

[email protected]

+39-035-2673341/4432

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

flexible video endoscopy of trachea

Device

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

Primary outcomes

  1. Diagnostic success rate of preoperative tracheoscopy

    Time frame: 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 outcomes

  1. Incidence of anesthetic complications

    Time frame: Intraoperative

    Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair

  2. 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)

    Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy

  3. Gastric distension

    Time frame: Perioperative (at initiation of the surgical procedure)

    Presence of gastric distension (yes/no) at the beginning of the surgical phase

  4. Arterial blood gas values at baseline

    Time frame: Baseline (immediately before tracheoscopy)

    Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at baseline (prior to tracheoscopy)

  5. Arterial blood gas values at beginning of surgery

    Time frame: Perioperative (at initiation of the surgical procedure)

    Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at beginning of the surgical procedure

  6. Arterial blood gas values at end of surgery

    Time frame: 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

Other outcomes

  1. Incidence of gastric distension at end of surgery

    Time frame: At conclusion of the surgical procedure (up to 30 minutes)

    Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Mariconti, MD

CONTACT

[email protected]

+39 035.267.5150/49

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Acronym: CBESB

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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