Klinische Anwendung des rechten visuellen Doppellumentubus in der thorakoskopischen Chirurgie bei erwachsenen Patienten (RIGHT-VDLT)
Vergleich der klinischen Anwendung von rechtsseitiger visueller Doppellumentubus und rechtsseitiger herkömmlicher Doppellumentubus in der thorakoskopischen Chirurgie bei erwachsenen Patienten
Diese klinische Studie zielt darauf ab zu verstehen, ob ein visueller Doppellumen-Intubationstubus im Vergleich zu einem Standard-Doppellumentubus die Erfolgsrate beim ersten Versuch verbessern und Komplikationen reduzieren kann. Die Studie zielt hauptsächlich darauf ab, folgende Fragen zu beantworten:
Verbessert ein Doppellumentubus die Erfolgsrate beim ersten Versuch?
Reduziert ein visueller Doppellumentubus die Wahrscheinlichkeit einer Obstruktion der rechten oberen Lappenbronchusöffnung?
Benötigt ein visueller Doppellumentubus während der Operation weniger Anpassungen?
Erleben Patienten mit visuellen Doppellumentuben im Vergleich zu Patienten mit Standard-Doppellumentuben weniger perioperative Komplikationen?
Die Teilnehmer werden:
Teilweise einen visuellen Doppellumentubus und teilweise einen Standard-Doppellumentubus verwenden.
Den perioperativen Status aller Patienten dokumentieren.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Heng Wen
- Telefonnummer: +8615158080827
- E-Mail: zyyywenheng@zju.edu.cn
Studienorte
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Rekrutierung
- The First Affiliated Hospital, Zhejiang University School of Medicine,
-
Kontakt:
- Heng Wen
-
Jiaxing, Zhejiang, China, 314000
- Rekrutierung
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
-
Jiaxing, Zhejiang, China, 314000
- Noch keine Rekrutierung
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Alter: mindestens 18 Jahre alt, Geschlecht ist nicht begrenzt.
- American Anesthesiologists Association (ASA) Grad I-III;
- Elektive videoassistierte thorakoskopische Lobektomie.
- Informierte Einwilligung des Patienten oder Familienmitglieds.
- Personen, die bereit sind, perioperative Besuche zu akzeptieren.
Ausschlusskriterien:
- Patienten mit Kontraindikationen für die Einführung eines rechtsseitigen Doppellumentubus (wie z.B. rechtseitiger Bronchialtumor).
- Der Patient hat bekannte tracheobronchiale anatomische Anomalien.
- Patienten, bei denen zuvor Atemwegsschwierigkeiten diagnostiziert oder vermutet wurden.
- Patienten, die eine Rapid-Sequence-Induktion benötigen.
- Patienten, die eine Notfalloperation benötigen.
- Patienten, die in den letzten vier Wochen eine Thoraxoperation, eine systemische Infektion oder vermutete Tuberkulose hatten.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Successful initial right-sided double-lumen tube placement
Zeitfenster: 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).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of right upper-lobe bronchial obstruction
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- ZJU2025C144
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .