Aplicação Clínica do Tubo de Duplo Lúmen Visual Direito em Cirurgia Toracoscópica para Pacientes Adultos (RIGHT-VDLT)
Comparação da Aplicação Clínica do Tubo Duplo Lumen Visual Direito e do Tubo Duplo Lumen Ordinário Direito em Cirurgia Toracoscópica para Pacientes Adultos
Este ensaio clínico visa compreender se um tubo de entubação de duplo lúmen visual pode melhorar a taxa de sucesso na primeira tentativa e reduzir as complicações em comparação com um tubo de duplo lúmen padrão. O ensaio pretende principalmente responder às seguintes questões:
O tubo de duplo lúmen melhora a taxa de sucesso na primeira tentativa?
O tubo de duplo lúmen visual reduz a probabilidade de obstrução da abertura brônquica do lobo superior direito?
O tubo de duplo lúmen visual requer menos ajustes durante a cirurgia?
Os pacientes com tubos de duplo lúmen visual experienciam menos complicações perioperatórias em comparação com aqueles com tubos de duplo lúmen padrão?
Os participantes irão:
Utilizar um tubo de duplo lúmen visual parcialmente e um tubo de duplo lúmen padrão parcialmente.
Registrar o estado perioperatório de todos os pacientes.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Heng Wen
- Número de telefone: +8615158080827
- E-mail: zyyywenheng@zju.edu.cn
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recrutamento
- The First Affiliated Hospital, Zhejiang University School of Medicine,
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Contato:
- Heng Wen
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Jiaxing, Zhejiang, China, 314000
- Recrutamento
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
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Jiaxing, Zhejiang, China, 314000
- Ainda não está recrutando
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Critérios de Inclusão:
- Idade: pelo menos 18 anos, o género não é limitado.
- Associação Americana de Anestesiologistas (ASA) Grau I-III;
- Lobectomia Toracoscópica Assistida por Vídeo Electiva.
- Consentimento informado do paciente ou familiar.
- Pessoas dispostas a aceitar visitas perioperatórias.
Critérios de Exclusão:
- Pacientes com contraindicações para a inserção de tubo de duplo lúmen direito (como tumor brônquico direito).
- O paciente tem anomalias anatómicas traqueobrônquicas conhecidas.
- Pacientes previamente diagnosticados ou suspeitos de ter dificuldade nas vias aéreas.
- Pacientes que necessitam de indução de sequência rápida.
- Pacientes que necessitam de cirurgia de emergência.
- Pacientes que realizaram cirurgia torácica, infecção sistémica ou suspeita de tuberculose nas últimas quatro semanas.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
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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.
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|
Comparador Ativo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Successful initial right-sided double-lumen tube placement
Prazo: 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).
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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.
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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).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of right upper-lobe bronchial obstruction
Prazo: After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
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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.
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After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
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Incidence of intraoperative double-lumen tube displacement
Prazo: From initiation of one-lung ventilation until completion of one-lung ventilation.
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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.
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From initiation of one-lung ventilation until completion of one-lung ventilation.
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Incidence of hypoxemia during one-lung ventilation
Prazo: During one-lung ventilation.
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Hypoxemia is defined as peripheral oxygen saturation (SpO₂) <90% during one-lung ventilation.
The outcome will be recorded as present or absent.
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During one-lung ventilation.
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Requirement for rescue fibreoptic bronchoscopy
Prazo: From completion of initial tube positioning until completion of one-lung ventilation.
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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.
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From completion of initial tube positioning until completion of one-lung ventilation.
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Time to satisfactory right-sided double-lumen tube positioning
Prazo: During initial tube placement after anaesthesia induction (approximately 10 minutes).
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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.
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During initial tube placement after anaesthesia induction (approximately 10 minutes).
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Quality of operative lung collapse
Prazo: 20 minutes after initiation of one-lung ventilation.
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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
Prazo: From initiation of one-lung ventilation until completion of one-lung ventilation.
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The number of separate tube repositioning procedures required after satisfactory initial placement will be recorded for each participant.
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From initiation of one-lung ventilation until completion of one-lung ventilation.
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ZJU2025C144
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