Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Airway Exchange Catheter-Guided Endotracheal Tube Exchange
  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.
• Процедура Bronchoscope-Guided Endotracheal Tube Exchange
  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.

Первичные конечные точки

• Ventilation interruption time during endotracheal tube exchange [Срок оценки: During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).]

Вторичные конечные точки (5)

• Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швейцария · 1 центр

• Unversity Hospital of Basel — Basel

Публикации

• Thiel W. [The preservation of the whole corpse with natural color]. Ann Anat. 1992 Jun;174(3):185-95. German. PMID 1503236
• Harris K, Chalhoub M, Maroun R, Elsayegh D. Endotracheal tube exchangers: should we look for safer alternatives? Heart Lung. 2012 Jan-Feb;41(1):67-9. doi: 10.1016/j.hrtlng.2011.06.005. Epub 2011 Aug 10. PMID 21831436
• Corso RM, Sorbello M, Mecugni D, Seligardi M, Piraccini E, Agnoletti V, Gamberini E, Maitan S, Petitti T, Cataldo R. Safety and efficacy of Staged Extubation Set in patients with difficult airway: a prospective multicenter study. Minerva Anestesiol. 2020 Aug;86(8):827-834. doi: 10.23736/S0375-9393.20.14105-1. Epub 2020 Mar 6. PMID 32154681
• McLean S, Lanam CR, Benedict W, Kirkpatrick N, Kheterpal S, Ramachandran SK. Airway exchange failure and complications with the use of the Cook Airway Exchange Catheter(R): a single center cohort study of 1177 patients. Anesth Analg. 2013 Dec;117(6):1325-7. doi: 10.1213/ANE.0b013e3182a7cd3d. PMID 24257382

Идентификаторы

NCT: NCT07706309 · EKNZ 2026-01277

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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