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Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange (Bronchex)

2026年7月10日 更新者:Léo Franchetti

Bronchoscopic Endotracheal Tube Exchange as an Alternative to Airway Exchange Catheter-Guided Tube Exchange: A Prospective Study

This prospective experimental study compares two methods for replacing an endotracheal tube in Thiel-embalmed body donors. The conventional method uses an airway exchange catheter based on the Seldinger technique, whereas the investigational method uses a flexible bronchoscope to provide direct visual guidance throughout the exchange.

The primary outcome is the duration of interrupted ventilation, measured from cessation of ventilation until ventilation is resumed through a correctly positioned replacement tube. Secondary outcomes include unsuccessful tube exchange requiring complete reintubation, duration of individual procedural steps, procedures lasting more than 60 seconds, use of additional rescue equipment, and unforeseen technical difficulties.

Both techniques will be performed in two Thiel-embalmed donated human bodies using an alternating sequence. Four experienced physicians will perform 40 tube exchanges per technique, resulting in a total of 80 procedures.

研究概览

详细说明

Endotracheal tube exchange may be required because of cuff failure, inappropriate tube size, tube damage, luminal obstruction, or the need for a planned intervention. During conventional tube exchange over an airway exchange catheter, continuous visualization of the subglottic airway and trachea is not possible. Consequently, advancement of the replacement tube may fail or may result in airway injury.

The bronchoscopic tube-exchange technique is intended to provide continuous visual control throughout the procedure and immediate confirmation of the replacement tube position.

The study will be conducted using two human bodies donated for medical education and research and preserved using the Thiel embalming method. Before each experimental series, the donated body will be intubated with a 7.5-mm endotracheal tube, and tracheobronchial secretions will be suctioned.

Two experienced physicians in intensive care medicine and anesthesiology will perform the conventional airway exchange catheter-guided technique, and two experienced pulmonologists will perform the bronchoscopic technique. To minimize order, learning, and tissue-wear effects, the techniques will be alternated. The starting technique will differ between the two body donors.

Each physician will perform 10 tube exchanges per body donor using the assigned technique, resulting in 20 procedures per physician, 40 procedures per technique, and 80 procedures overall.

Procedure timing will be based on predefined start and end points. The primary interval begins when ventilation is interrupted and ends when ventilation is resumed through the correctly positioned replacement tube. A trained observer will record procedural times, individual procedural steps, technical difficulties, use of additional equipment, and unsuccessful exchanges using a standardized source document.

Where feasible, video or photographic documentation may be used to verify procedure timing and technical events. The face will remain covered to prevent identification of the body donor.

Continuous outcomes will be analyzed using the paired Wilcoxon signed-rank test. Paired dichotomous outcomes will be analyzed using the McNemar test. Descriptive statistics will include medians, interquartile ranges, and ranges.

研究类型

介入性

注册 (估计的)

2

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Basel、瑞士
        • 招聘中
        • Unversity Hospital of Basel
        • 接触:
          • Léo Franchetti, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Human body donor preserved using the Thiel embalming method.
  • Intact trachea without relevant postmortem or preparation-related lesions.
  • Documented consent for scientific use of the body and confirmation of anatomical suitability by the Institute of Anatomy.
  • Sufficient mobility of the neck, jaw, and laryngeal region to permit realistic tube-exchange maneuvers.

Exclusion Criteria:

  • Tumor or stenosis involving the larynx, trachea, or central airways.
  • Previous surgery or radiotherapy involving the larynx or oral cavity.
  • Previous pneumonectomy.
  • Previous tracheotomy or laryngectomy.
  • Inability to achieve safe or standardized positioning of the cadaver.
  • Incomplete consent documentation or unclear provenance.
  • Preservation using a fixation method other than the Thiel method.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:非随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Airway Exchange Catheter
The body donors will undergo a tube exchange with the conventional airway exchange catheter-guided technique
The existing tube fixation is released. A Cook airway exchange catheter is advanced through the in-situ endotracheal tube into the tracheobronchial tree. Ventilation is interrupted, the cuff is deflated, and the old tube is removed over the catheter. A new endotracheal tube is advanced over the catheter, the catheter is removed, the cuff is inflated, ventilation is resumed, and tube position is verified by lung auscultation.
其他名称:
  • Cook Catheter Tube Exchange
实验性的:Bronchoscopic tube exchange
The body donors will undergo a tube exchange with the bronchoscopic tube-exchange technique
The replacement tube is preloaded onto a therapeutic flexible bronchoscope. The bronchoscope is advanced alongside the in-situ tube through the larynx into the trachea, and proximal tracheal secretions are suctioned. Ventilation is interrupted and the old tube is removed. The replacement tube is advanced over the bronchoscope into the trachea under direct visual control. The bronchoscope is removed, the cuff is inflated, and ventilation is resumed.
其他名称:
  • Bronchoscopic tube exchange

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ventilation interruption time during endotracheal tube exchange
大体时间:During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).
Time in seconds from interruption of ventilation until ventilation is resumed through the correctly positioned replacement tube
During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).

次要结果测量

结果测量
大体时间
Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required.
大体时间:Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Duration of individual procedural steps - time in seconds for predefined components, including preparation and tube advancement.
大体时间:Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Tube exchanges lasting more than 60 seconds - number and proportion of procedures with ventilation interruption exceeding 60 seconds.
大体时间:Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Use of additional rescue equipment - number and proportion of exchanges requiring an additional device, such as a laryngoscope.
大体时间:Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Unforeseen technical difficulties - type and frequency of technical problems not predefined in the protocol.
大体时间:Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月10日

初级完成 (估计的)

2026年7月10日

研究完成 (估计的)

2026年7月10日

研究注册日期

首次提交

2026年7月10日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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