Applicazione Clinica del Tubo a Doppio Lume Visivo Destro nella Chirurgia Toracoscopica per Pazienti Adulti (RIGHT-VDLT)
Confronto dell'Applicazione Clinica del Tubo Doppio Lume Visivo Destro e del Tubo Doppio Lume Ordinario Destro nella Chirurgia Toracoscopica per Pazienti Adulti
Questo studio clinico mira a comprendere se un tubo di intubazione a doppio lume visivo può migliorare il tasso di successo al primo tentativo e ridurre le complicazioni rispetto a un tubo a doppio lume standard. Lo studio mira principalmente a rispondere alle seguenti domande:
Un tubo a doppio lume migliora il tasso di successo al primo tentativo?
Un tubo a doppio lume visivo riduce la probabilità di ostruzione dell'apertura bronchiale del lobo superiore destro?
Un tubo a doppio lume visivo richiede meno aggiustamenti durante l'intervento chirurgico?
I pazienti con tubi a doppio lume visivo sperimentano meno complicazioni perioperatorie rispetto a quelli con tubi a doppio lume standard?
I partecipanti:
Utilizzeranno parzialmente un tubo a doppio lume visivo e parzialmente un tubo a doppio lume standard.
Registreranno lo stato perioperatorio di tutti i pazienti.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Heng Wen
- Numero di telefono: +8615158080827
- Email: zyyywenheng@zju.edu.cn
Luoghi di studio
-
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310000
- Reclutamento
- The First Affiliated Hospital, Zhejiang University School of Medicine,
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Contatto:
- Heng Wen
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Jiaxing, Zhejiang, Cina, 314000
- Reclutamento
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
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Jiaxing, Zhejiang, Cina, 314000
- Non ancora reclutamento
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Criteri di inclusione:
- Età: almeno 18 anni, il genere non è limitato.
- Grado I-III dell'American Anesthesiologists Association (ASA).
- Lobectomia toracoscopica video-assistita elettiva.
- Consenso informato del paziente o di un familiare.
- Persone disposte ad accettare visite perioperatorie.
Criteri di esclusione:
- Pazienti con controindicazioni per l'inserimento di un tubo a doppio lume destro (ad esempio tumore bronchiale destro).
- Il paziente presenta anomalie anatomiche tracheobronchiali note.
- Pazienti precedentemente diagnosticati o sospettati di avere difficoltà delle vie aeree.
- Pazienti che necessitano di induzione a sequenza rapida.
- Pazienti che richiedono chirurgia d'urgenza.
- Pazienti che hanno subito chirurgia toracica, infezione sistemica o sospetta tubercolosi nelle ultime quattro settimane.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Successful initial right-sided double-lumen tube placement
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of right upper-lobe bronchial obstruction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- ZJU2025C144
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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