Aplicación Clínica del Tubo Doble Lumen Visual Derecho en Cirugía Toracoscópica para Pacientes Adultos (RIGHT-VDLT)
Comparación de la Aplicación Clínica del Tubo Doble Lumen Visual Derecho y el Tubo Doble Lumen Ordinario Derecho en Cirugía Toracoscópica para Pacientes Adultos
Este ensayo clínico tiene como objetivo comprender si un tubo de intubación de doble luz visual puede mejorar la tasa de éxito en el primer intento y reducir las complicaciones en comparación con un tubo de doble luz estándar. El ensayo pretende responder principalmente a las siguientes preguntas:
¿Mejora un tubo de doble luz la tasa de éxito en el primer intento?
¿Reduce un tubo de doble luz visual la probabilidad de obstrucción de la abertura bronquial del lóbulo superior derecho?
¿Requiere un tubo de doble luz visual menos ajustes durante la cirugía?
¿Experimentan los pacientes con tubos de doble luz visual menos complicaciones perioperatorias en comparación con aquellos con tubos de doble luz estándar?
Los participantes:
Utilizarán parcialmente un tubo de doble luz visual y parcialmente un tubo de doble luz estándar.
Registrarán el estado perioperatorio de todos los pacientes.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Right-sided double-lumen tubes are used to achieve lung isolation and one-lung ventilation during thoracoscopic surgery. Accurate positioning is particularly important because of the short right main bronchus and the need to maintain patency of the right upper-lobe bronchial opening. Malposition or displacement of a right-sided double-lumen tube may impair right upper-lobe ventilation, compromise lung isolation, and require repeated tube repositioning or fibreoptic bronchoscopy.
This prospective, multicentre, parallel-group randomised controlled trial will enrol 566 adult participants undergoing elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube. Participants will be randomly allocated in a 1:1 ratio to either a video-guided right-sided double-lumen tube or a conventional right-sided double-lumen tube.
In the video-guided group, an integrated visualisation system provides continuous airway visual feedback during initial tube positioning and intraoperative monitoring, allowing real-time identification of changes in tube position. In the conventional group, initial tube placement is performed using standard clinical techniques and anatomical landmarks.
After initial positioning, final tube position will be confirmed by fibreoptic bronchoscopy in both groups. Subsequent fibreoptic bronchoscopy during one-lung ventilation will be performed only when clinically indicated or according to predefined rescue criteria.
The primary outcome is successful initial right-sided double-lumen tube placement, defined as placement of the assigned tube on the first intubation attempt with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation.
Secondary outcomes include the incidence of right upper-lobe bronchial obstruction confirmed by fibreoptic bronchoscopy; incidence of intraoperative double-lumen tube displacement; incidence of hypoxemia during one-lung ventilation; requirement for rescue fibreoptic bronchoscopy; time to satisfactory right-sided double-lumen tube positioning; quality of operative lung collapse assessed by the operating surgeon; and the number of intraoperative tube repositioning events.
Participants and outcome assessors will remain blinded to treatment allocation. Because the video-guided and conventional right-sided double-lumen tubes have distinct visual and operational characteristics, the anaesthesiologist performing tracheal intubation and other intraoperative personnel directly involved in airway management cannot be blinded. Outcome assessment will be performed by personnel who are not involved in the airway intervention and remain unaware of treatment allocation.
The trial is designed to determine whether continuous airway visualisation improves initial placement success, maintains more stable right-sided double-lumen tube positioning, reduces the need for subsequent airway interventions, and improves clinically relevant conditions during one-lung ventilation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Heng Wen
- Número de teléfono: +8615158080827
- Correo electrónico: zyyywenheng@zju.edu.cn
Ubicaciones de estudio
-
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310000
- Reclutamiento
- The First Affiliated Hospital, Zhejiang University School of Medicine,
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Contacto:
- Heng Wen
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Jiaxing, Zhejiang, Porcelana, 314000
- Reclutamiento
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
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Jiaxing, Zhejiang, Porcelana, 314000
- Aún no reclutando
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- Edad: al menos 18 años, sin límite de género.
- Grado I-III de la American Anesthesiologists Association (ASA).
- Lobectomía toracoscópica asistida por video electiva.
- Consentimiento informado del paciente o familiar.
- Personas dispuestas a aceptar visitas perioperatorias.
Criterios de exclusión:
- Pacientes con contraindicaciones para la inserción de un tubo de doble luz derecho (como tumor bronquial derecho).
- El paciente tiene anomalías anatómicas traqueobronquiales conocidas.
- Pacientes previamente diagnosticados o sospechosos de tener dificultad de vía aérea.
- Pacientes que necesitan inducción en secuencia rápida.
- Pacientes que requieren cirugía de emergencia.
- Pacientes que han sido sometidos a cirugía torácica, infección sistémica o sospecha de tuberculosis en las últimas cuatro semanas.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Video-guided right-sided double-lumen tube
Participants undergo lung isolation for thoracoscopic surgery using a video-guided right-sided double-lumen tube.
The integrated camera provides continuous airway visualisation to facilitate initial positioning and intraoperative detection of tube displacement.
Final tube position is confirmed by fibreoptic bronchoscopy after initial positioning.
Subsequent fibreoptic bronchoscopy during one-lung ventilation is performed only when clinically indicated or according to predefined rescue criteria.
|
A right-sided double-lumen tube with an integrated visualisation system that provides continuous airway visual feedback during placement and intraoperative monitoring.
Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
|
|
Comparador activo: Conventional right-sided double-lumen tube
A conventional right-sided double-lumen tube used for lung isolation.
Initial placement is performed using standard clinical techniques and anatomical landmarks.
Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
|
A conventional right-sided double-lumen tube used for lung isolation.
Initial placement is performed using standard clinical techniques and anatomical landmarks.
Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful initial right-sided double-lumen tube placement
Periodo de tiempo: From initial insertion of the assigned right-sided double-lumen tube until confirmation of satisfactory tube position before initiation of one-lung ventilation (approximately 10 minutes).
|
Successful initial placement is defined as placement of the assigned right-sided double-lumen tube on the first intubation attempt, with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation.
|
From initial insertion of the assigned right-sided double-lumen tube until confirmation of satisfactory tube position before initiation of one-lung ventilation (approximately 10 minutes).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of right upper-lobe bronchial obstruction
Periodo de tiempo: After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
|
Right upper-lobe bronchial obstruction is defined as partial or complete obstruction of the right upper-lobe bronchial opening by the bronchial lumen or bronchial cuff after initial tube positioning, as confirmed by fibreoptic bronchoscopy.
The outcome will be recorded as present or absent.
|
After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
|
|
Incidence of intraoperative double-lumen tube displacement
Periodo de tiempo: From initiation of one-lung ventilation until completion of one-lung ventilation.
|
Tube displacement is defined as any intraoperative displacement of the double-lumen tube that requires repositioning to restore satisfactory tube position, ventilation, or lung isolation.
The outcome will be recorded as present or absent.
|
From initiation of one-lung ventilation until completion of one-lung ventilation.
|
|
Incidence of hypoxemia during one-lung ventilation
Periodo de tiempo: During one-lung ventilation.
|
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) <90% during one-lung ventilation.
The outcome will be recorded as present or absent.
|
During one-lung ventilation.
|
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Requirement for rescue fibreoptic bronchoscopy
Periodo de tiempo: From completion of initial tube positioning until completion of one-lung ventilation.
|
Rescue fibreoptic bronchoscopy is defined as fibreoptic bronchoscopy performed after initial tube positioning because of suspected tube malposition, inadequate lung isolation, ventilation abnormality, or need for tube repositioning.
The outcome will be recorded as present or absent.
|
From completion of initial tube positioning until completion of one-lung ventilation.
|
|
Time to satisfactory right-sided double-lumen tube positioning
Periodo de tiempo: During initial tube placement after anaesthesia induction (approximately 10 minutes).
|
Time from removal of the stylet after the bronchial cuff passes the vocal cords to confirmation of satisfactory right-sided double-lumen tube position.
The duration will be recorded in seconds.
|
During initial tube placement after anaesthesia induction (approximately 10 minutes).
|
|
Quality of operative lung collapse
Periodo de tiempo: 20 minutes after initiation of one-lung ventilation.
|
The operating surgeon, blinded to treatment allocation, will assess operative lung collapse using a three-category scale: excellent (complete collapse with optimal surgical exposure), good (minor residual inflation without interference with surgery), or poor (incomplete collapse interfering with surgical exposure).
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20 minutes after initiation of one-lung ventilation.
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Number of intraoperative double-lumen tube repositioning events
Periodo de tiempo: From initiation of one-lung ventilation until completion of one-lung ventilation.
|
The number of separate tube repositioning procedures required after satisfactory initial placement will be recorded for each participant.
|
From initiation of one-lung ventilation until completion of one-lung ventilation.
|
Colaboradores e Investigadores
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
- ZJU2025C144
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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