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临床试验/NCT07687628
NCT07687628招募中不适用

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

Papa Giovanni XXIII Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Diagnostic success rate of preoperative tracheoscopy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Refusal or inability to obtain informed consent from parents or legal guardian

结局指标

主要结局

Diagnostic success rate of preoperative tracheoscopy

时间窗: 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)

次要结局

  • Gastric distension(Perioperative (at initiation of the surgical procedure))
  • Incidence of anesthetic complications(Intraoperative)
  • 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))
  • Arterial blood gas values at baseline(Baseline (immediately before tracheoscopy))
  • Arterial blood gas values at beginning of surgery(Perioperative (at initiation of the surgical procedure))
  • Arterial blood gas values at end of surgery(At conclusion of the surgical procedure (up to 30 minutes))

研究者

发起方
Papa Giovanni XXIII Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Mariconti

Consultant, MD

Papa Giovanni XXIII Hospital

研究点 (1)

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