- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07706309
Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange (Bronchex)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Léo Franchetti, MD
- Número de teléfono: +41 61 265 25 25
- Correo electrónico: leo.franchetti@usb.ch
Copia de seguridad de contactos de estudio
- Nombre: Prof. Jürgen Hetzel, MD
- Número de teléfono: +41 61 328 61 95
- Correo electrónico: juergen.hetzel@usb.ch
Ubicaciones de estudio
-
-
-
Basel, Suiza
- Reclutamiento
- Unversity Hospital of Basel
-
Contacto:
- Léo Franchetti, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
Otros nombres:
|
|
Experimental: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ventilation interruption time during endotracheal tube exchange
Periodo de tiempo: 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).
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
|
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Thiel W. [The preservation of the whole corpse with natural color]. Ann Anat. 1992 Jun;174(3):185-95. German.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- EKNZ 2026-01277
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .