Bronchoscopic Endotracheal Tube Exchange as an Alternative to Airway Exchange Catheter-Guided Tube Exchange: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ventilation interruption time during endotracheal tube exchange
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Ventilation interruption time during endotracheal tube exchange
时间窗: 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
次要结局
- Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required.(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.(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.(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.(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.(Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).)
研究者
Léo Franchetti
Physician, Department of Pneumology, University Hospital Basel
University Hospital, Basel, Switzerland