- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07687628
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula (CBESB)
1 juli 2026 uppdaterad av: Stefano Mariconti, Papa Giovanni XXIII Hospital
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
60
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Stefano Mariconti, MD
- Telefonnummer: +39 035.267.5150/49
- E-post: smariconti@asst-pg23.it
Studieorter
-
-
Italy
-
Bergamo, Italy, Italien, 24100
- Rekrytering
- Sc Ricerca Clinica, Sviluppo E Innovazione
-
Kontakt:
- Monia Lorini, Director
- Telefonnummer: +39-035-2673341/4432
- E-post: mlorini@asst-pg23.it
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates
|
|
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.
|
Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic success rate of preoperative tracheoscopy
Tidsram: 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)
|
Intraoperative (at the time of the preoperative tracheoscopy procedure)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of anesthetic complications
Tidsram: Intraoperative
|
Rate of preoperative or intraoperative anesthetic complications (respiratory, cardiovascular) during tracheoscopy and surgical repair
|
Intraoperative
|
|
Learning curve of each tracheoscopy technique
Tidsram: 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
|
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
Tidsram: Perioperative (at initiation of the surgical procedure)
|
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
Tidsram: Baseline (immediately before tracheoscopy)
|
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
Tidsram: Perioperative (at initiation of the surgical procedure)
|
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
Tidsram: 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
|
At conclusion of the surgical procedure (up to 30 minutes)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of gastric distension at end of surgery
Tidsram: At conclusion of the surgical procedure (up to 30 minutes)
|
Presence of gastric distension (yes/no), assessed at conclusion of the surgical procedure
|
At conclusion of the surgical procedure (up to 30 minutes)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Ezio Bonanomi, MD, A.O. Ospedale Papa Giovanni XXIII
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2024
Primärt slutförande (Beräknad)
31 januari 2029
Avslutad studie (Beräknad)
31 januari 2031
Studieregistreringsdatum
Först inskickad
26 juni 2026
Först inskickad som uppfyllde QC-kriterierna
1 juli 2026
Första postat (Faktisk)
7 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska tillstånd, anatomiska
- Luftvägssjukdomar
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Esofagussjukdomar
- Fistel i matsmältningssystemet
- Fistel
- Trakeal sjukdomar
- Luftvägsfistel
- Esophageal fistel
- Patologiska tillstånd, tecken och symtom
- Trakeesofageal fistel
- Esophageal atresia med eller utan trakeoesofageal fistel
Andra studie-ID-nummer
- VideoendoFTE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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