Идёт набор NCT07687628

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

— Наблюдательное Tracheoesophageal Fistula Esophageal Atresia With Tracheo-esophageal Fistula

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: tracheoscopy performed with rigid optical tracheoscopy, flexible video endoscopy of trachea.
Кому может быть актуально: Состояния в реестре: Tracheoesophageal Fistula, Esophageal Atresia With Tracheo-esophageal Fistula. Базовые параметры: 0 Days — 28 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Diagnostic success rate of preoperative tracheoscopy [Срок оценки: Intraoperative (at the time of the preoperative tracheoscopy procedure)]

Вторичные конечные точки (6)

Incidence of anesthetic complications [Срок оценки: Intraoperative]
Learning curve of each tracheoscopy technique [Срок оценки: 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 [Срок оценки: Perioperative (at initiation of the surgical procedure)]
Arterial blood gas values at baseline [Срок оценки: Baseline (immediately before tracheoscopy)]
Arterial blood gas values at beginning of surgery [Срок оценки: Perioperative (at initiation of the surgical procedure)]
Arterial blood gas values at end of surgery [Срок оценки: At conclusion of the surgical procedure (up to 30 minutes)]

Критерии участия

Критерии включения

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