Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorPapa Giovanni XXIII Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal or inability to obtain informed consent from parents or legal guardian
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
tracheoscopy performed with rigid optical tracheoscopy
Procedure/SurgeryRigid 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
DeviceFlexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: flexible video-endoscopy1 intervention
Group B: rigid tracheoscopy1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Intraoperative (at the time of the preoperative tracheoscopy procedure)Secondary outcomes
1
Incidence of anesthetic complications
Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
Time frame
Intraoperative2
Learning curve of each tracheoscopy technique
Number of supervised procedures required before the operator achieved adequate autonomous proficiency with rigid vs flexible bronchoscopy
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)3
Gastric distension
Presence of gastric distension (yes/no) at the beginning of the surgical phase
Time frame
Perioperative (at initiation of the surgical procedure)4
Arterial blood gas values at baseline
Arterial blood gas parameters (pH, PCO2, PO2, lactate, base excess) at baseline (prior to tracheoscopy)
Time frame
Baseline (immediately before tracheoscopy)Other outcomes
1
Incidence of gastric distension at end of surgery
Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure
Time frame
At conclusion of the surgical procedure (up to 30 minutes)Sponsors and contacts
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Source ClinicalTrials.gov