Klinisk anvendelse av høyre visuell dobbeltlumen tube ved torakoskopisk kirurgi for voksne pasienter (RIGHT-VDLT)
Sammenligning av klinisk anvendelse av høyre visuell dobbeltlumentube og høyre vanlig dobbeltlumentube i torakoskopisk kirurgi for voksne pasienter
Denne kliniske studien har som mål å forstå om en visuell dobbeltlumen intubasjonstube kan forbedre suksessraten ved første forsøk og redusere komplikasjoner sammenlignet med en standard dobbeltlumen tube.
Studien har primært som mål å svare på følgende spørsmål:
Forbedrer en dobbeltlumen tube suksessraten ved første forsøk?
Reduserer en visuell dobbeltlumen tube sannsynligheten for obstruksjon av høyre øvre lobebronkieåpning?
Krever en visuell dobbeltlumen tube færre justeringer under operasjonen?
Opplever pasienter med visuelle dobbeltlumen tube færre perioperative komplikasjoner sammenlignet med de med standard dobbeltlumen tube?
Deltakere vil:
Bruke en visuell dobbeltlumen tube delvis og en standard dobbeltlumen tube delvis.
Registrere perioperativ status for alle pasienter.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Heng Wen
- Telefonnummer: +8615158080827
- E-post: zyyywenheng@zju.edu.cn
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- Rekruttering
- The First Affiliated Hospital, Zhejiang University School of Medicine,
-
Ta kontakt med:
- Heng Wen
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Jiaxing, Zhejiang, Kina, 314000
- Rekruttering
- Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
-
Jiaxing, Zhejiang, Kina, 314000
- Har ikke rekruttert ennå
- The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Alder: minst 18 år gammel, kjønn er ikke begrenset.
- American Anesthesiologists Association (ASA) grad I-III;
- Elektiv videotorakoskopisk lobektomi.
- Informerte samtykke fra pasienten eller familiemedlem.
- Personer som er villige til å akseptere perioperative besøk.
Eksklusjonskriterier:
- Pasienter med kontraindikasjoner for innsetting av høyre dobbeltlumen tube (slik som høyre bronkialtumor).
- Pasienten har kjente trakeobronkiale anatomiske avvik
- Pasienter tidligere diagnostisert eller mistenkt for luftveisvansker.
- Pasienter som trenger rask sekvensinduksjon.
- Pasienter som krever akutt operasjon
- Pasienter som har gjennomgått thorakal kirurgi, systemisk infeksjon eller mistenkt tuberkulose de siste fire ukene.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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 |
Tiltaksbeskrivelse |
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).
|
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.
|
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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ZJU2025C144
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