Klinisk anvendelse af højre visuel dobbeltlumen tube i thorakoskopisk kirurgi for voksne patienter (RIGHT-VDLT)
Sammenligning af klinisk anvendelse af højre visuel dobbeltlumentubus og højre almindelig dobbeltlumentubus i thorakoskopisk kirurgi for voksne patienter
Dette kliniske forsøg har til formål at forstå, om en visuel dobbelt-lumen intubationstubus kan forbedre succesraten ved første forsøg og reducere komplikationer sammenlignet med en standard dobbelt-lumen tubus. Forsøget har primært til formål at besvare følgende spørgsmål:
Forbedrer en dobbelt-lumen tubus succesraten ved første forsøg?
Reducerer en visuel dobbelt-lumen tubus sandsynligheden for obstruktion af den øverste højre bronkieåbning?
Kræver en visuel dobbelt-lumen tubus færre justeringer under operationen?
Oplever patienter med visuelle dobbelt-lumen tuber færre perioperative komplikationer sammenlignet med dem med standard dobbelt-lumen tuber?
Deltagere vil:
Bruge en visuel dobbelt-lumen tubus delvist og en standard dobbelt-lumen tubus delvist.
Registrere alle patienters perioperative status.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Heng Wen
- Telefonnummer: +8615158080827
- E-mail: zyyywenheng@zju.edu.cn
Studiesteder
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- Rekruttering
- The First Affiliated Hospital, Zhejiang University School of Medicine,
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Kontakt:
- Heng Wen
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Jiaxing, Zhejiang, Kina, 314000
- Rekruttering
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
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Jiaxing, Zhejiang, Kina, 314000
- Ikke rekrutterer endnu
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Alder: mindst 18 år, køn er ikke begrænset.
- American Anesthesiologists Association (ASA) grad I-III;
- Elektiv videoassisteret thorakoskopisk lobektomi.
- Informert samtykke fra patienten eller familie.
- Personer, der er villige til at acceptere perioperative besøg.
Eksklusionskriterier:
- Patienter med kontraindikationer for indsættelse af højre dobbeltlumen tube (såsom højre bronkial tumor).
- Patienten har kendte trakeobronkiale anatomiske abnormiteter.
- Patienter tidligere diagnosticeret eller mistænkt for at have luftvejssværheder.
- Patienter, der har brug for hurtig sekvensinduktion.
- Patienter, der kræver akut operation.
- Patienter, der har gennemgået thoraxkirurgi, systemisk infektion eller mistænkt tuberkulose inden for de sidste fire uger.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Successful initial right-sided double-lumen tube placement
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of right upper-lobe bronchial obstruction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ZJU2025C144
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