Application clinique du tube double lumière visuel droit en chirurgie thoracoscopique pour patients adultes (RIGHT-VDLT)
Comparaison de l'application clinique du tube double lumière droit à vision et du tube double lumière droit ordinaire dans la chirurgie thoracoscopique chez les patients adultes
Cette étude clinique vise à déterminer si un tube d'intubation à double lumière visuel peut améliorer le taux de réussite dès la première tentative et réduire les complications par rapport à un tube à double lumière standard. L'étude cherche principalement à répondre aux questions suivantes :
Un tube à double lumière améliore-t-il le taux de réussite dès la première tentative ?
Un tube à double lumière visuel réduit-il la probabilité d'obstruction de l'orifice bronchique du lobe supérieur droit ?
Un tube à double lumière visuel nécessite-t-il moins d'ajustements pendant la chirurgie ?
Les patients avec des tubes à double lumière visuel présentent-ils moins de complications périopératoires que ceux avec des tubes à double lumière standard ?
Les participants devront :
Utiliser partiellement un tube à double lumière visuel et partiellement un tube à double lumière standard.
Enregistrer l'état périopératoire de tous les patients.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Heng Wen
- Numéro de téléphone: +8615158080827
- E-mail: zyyywenheng@zju.edu.cn
Lieux d'étude
-
-
Zhejiang
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Hangzhou, Zhejiang, Chine, 310000
- Recrutement
- The First Affiliated Hospital, Zhejiang University School of Medicine,
-
Contact:
- Heng Wen
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Jiaxing, Zhejiang, Chine, 314000
- Recrutement
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
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Jiaxing, Zhejiang, Chine, 314000
- Pas encore de recrutement
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Critères d'inclusion :
- Âge : au moins 18 ans, le sexe n'est pas limité.
- Grade I-III de l'American Society of Anesthesiologists (ASA) ;
- Lobectomie thoracoscopique vidéo-assistée élective.
- Consentement éclairé du patient ou d'un membre de la famille.
- Personnes acceptant les visites périopératoires.
Critères d'exclusion :
- Patients présentant des contre-indications à l'insertion d'une sonde double lumière droite (comme une tumeur bronchique droite).
- Le patient présente des anomalies anatomiques trachéobronchiques connues.
- Patients ayant déjà été diagnostiqués ou suspectés de présenter des difficultés des voies aériennes.
- Patients nécessitant une induction en séquence rapide.
- Patients nécessitant une chirurgie d'urgence.
- Patients ayant subi une chirurgie thoracique, une infection systémique ou une suspicion de tuberculose au cours des quatre dernières semaines.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Successful initial right-sided double-lumen tube placement
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of right upper-lobe bronchial obstruction
Délai: 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
Délai: 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
Délai: 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.
|
|
Requirement for rescue fibreoptic bronchoscopy
Délai: 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
Délai: 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
Délai: 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).
|
20 minutes after initiation of one-lung ventilation.
|
|
Number of intraoperative double-lumen tube repositioning events
Délai: 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.
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ZJU2025C144
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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