Thoracoscopic SurgeryRIGHT-VDLTNCT07362797
Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery
A study testing Video-guided right-sided double-lumen tube and Conventional right-sided double-lumen tube in people with Thoracoscopic Surgery and Double Lumen Tube Intubation, run by Diansan Su at 3 sites in China.
Trial summary
This multicentre randomised controlled trial compares a video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adults undergoing elective thoracoscopic surgery requiring one-lung ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoscopic Surgery, Double Lumen Tube Intubation, One-Lung Ventilation
- What is being tested?
- Video-guided right-sided double-lumen tube and Conventional right-sided double-lumen tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 3 sitesChina
- Study dates
- 30 May 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- American Society of Anesthesiologists physical status I-III.
- Scheduled for elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube.
- Able to provide written informed consent.
Who cannot join
- Contraindication to placement of a right-sided double-lumen tube, including a lesion involving the right main bronchus that precludes its use.
- Known tracheobronchial anatomical abnormality that may interfere with right-sided double-lumen tube placement or lung isolation.
- Known or anticipated difficult airway.
- Requirement for rapid-sequence induction.
- Emergency surgery.
- Severe respiratory instability that, in the investigator's judgement, makes participation unsafe.
- Concurrent participation in another interventional clinical trial that could interfere with the present study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine,
Hangzhou, Zhejiang, 310000
Heng Wen
- Recruiting
Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
Jiaxing, Zhejiang, 314000
- Not yet recruiting
The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）
Jiaxing, Zhejiang, 314000
About this study
Official title: Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery: A Multicentre Randomized Controlled Trial
This multicentre randomised controlled trial compares a video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adults undergoing elective thoracoscopic surgery requiring one-lung ventilation. The video-guided tube incorporates an integrated camera that provides continuous airway visualisation during initial placement and intraoperative monitoring.
Participants will be randomly assigned in a 1:1 ratio to receive one of the two tubes. Final tube position after initial placement will be confirmed by fibreoptic bronchoscopy in both groups. During one-lung ventilation, additional fibreoptic bronchoscopy will be performed only when clinically indicated or according to predefined rescue criteria.
Read more
The primary outcome is successful initial right-sided double-lumen tube placement. Secondary outcomes include right upper-lobe bronchial obstruction, intraoperative tube displacement, hypoxemia during one-lung ventilation, requirement for rescue fibreoptic bronchoscopy, time to satisfactory tube positioning, quality of operative lung collapse, and the number of intraoperative tube repositioning events.
Participants and outcome assessors will remain blinded to treatment allocation, whereas the anaesthesiologist performing intubation cannot be blinded because of the distinct visual and operational characteristics of the two devices. The study aims to determine whether continuous airway visualisation improves the effectiveness and stability of right-sided double-lumen tube management during thoracoscopic surgery.
Read the detailed description
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.
- Being tested
- Video-guided right-sided double-lumen tube, Conventional right-sided double-lumen tube
- Keywords
- Video-guided right-sided double-lumen tube, Right-sided double-lumen tube, One-lung ventilation, Fibreoptic bronchoscopy, Thoracoscopic surgery, Lung isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-guided right-sided double-lumen tubeDevice
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.
Conventional right-sided double-lumen tubeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-guided right-sided double-lumen tube | Experimental | 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. Receives: Device: Video-guided right-sided double-lumen tube |
| Conventional right-sided double-lumen tube | Active comparator | 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. Receives: Device: Conventional right-sided double-lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful initial right-sided double-lumen tube placement
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.
Measured: 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).
Secondary outcomes (7)
Incidence of right upper-lobe bronchial obstruction
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.
Measured: After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
Incidence of intraoperative double-lumen tube displacement
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.
Measured: From initiation of one-lung ventilation until completion of one-lung ventilation.
Incidence of hypoxemia 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.
Measured: During one-lung ventilation.
Requirement for rescue fibreoptic bronchoscopy
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.
Measured: From completion of initial tube positioning until completion of one-lung ventilation.
Time to satisfactory right-sided double-lumen tube positioning
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.
Measured: During initial tube placement after anaesthesia induction (approximately 10 minutes).
Quality of operative lung collapse
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).
Measured: 20 minutes after initiation of one-lung ventilation.
Number of intraoperative double-lumen tube repositioning events
The number of separate tube repositioning procedures required after satisfactory initial placement will be recorded for each participant.
Measured: From initiation of one-lung ventilation until completion of one-lung ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 May 2026
- Primary completion24 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomized, parallel-group controlled trial with 1:1 allocation to video-guided right-sided double-lumen tube placement or conventional right-sided double-lumen tube placement.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diansan Su
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University
- Responsible party
- Sponsor-investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362797
- Sponsor's protocol ID
- ZJU2025C144
- Acronym
- RIGHT-VDLT
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant privacy considerations and the restrictions of the informed consent and ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery: A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07362797
- Acronym / sponsor ID
- RIGHT-VDLT / ZJU2025C144
- Keywords
- Video-guided right-sided double-lumen tube, Right-sided double-lumen tube, One-lung ventilation, Fibreoptic bronchoscopy, Thoracoscopic surgery, Lung isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Diansan SuUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University
- Study start
- 30 May 2026 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre randomised controlled trial compares a video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adults undergoing elective thoracoscopic surgery requiring one-lung ventilation. The video-guided tube incorporates an integrated camera that provides continuous airway visualisation during initial placement and intraoperative monitoring.
Participants will be randomly assigned in a 1:1 ratio to receive one of the two tubes. Final tube position after initial placement will be confirmed by fibreoptic bronchoscopy in both groups. During one-lung ventilation, additional fibreoptic bronchoscopy 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. Secondary outcomes include right upper-lobe bronchial obstruction, intraoperative tube displacement, hypoxemia during one-lung ventilation, requirement for rescue fibreoptic bronchoscopy, time to satisfactory tube positioning, quality of operative lung collapse, and the number of intraoperative tube repositioning events.
Participants and outcome assessors will remain blinded to treatment allocation, whereas the anaesthesiologist performing intubation cannot be blinded because of the distinct visual and operational characteristics of the two devices. The study aims to determine whether continuous airway visualisation improves the effectiveness and stability of right-sided double-lumen tube management during thoracoscopic surgery.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, randomized, parallel-group controlled trial with 1:1 allocation to video-guided right-sided double-lumen tube placement or conventional right-sided double-lumen tube placement.
| Arm | Type | Receives |
|---|---|---|
| Video-guided right-sided double-lumen tube | Experimental | Device: Video-guided right-sided double-lumen tubeParticipants 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. |
| Conventional right-sided double-lumen tube | Active comparator | Device: Conventional right-sided double-lumen tubeA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- American Society of Anesthesiologists physical status I-III.
- Scheduled for elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube.
- Able to provide written informed consent.
Key exclusion criteria (7 listed)
- Contraindication to placement of a right-sided double-lumen tube, including a lesion involving the right main bronchus that precludes its use.
- Known tracheobronchial anatomical abnormality that may interfere with right-sided double-lumen tube placement or lung isolation.
- Known or anticipated difficult airway.
- Requirement for rapid-sequence induction.
- Emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-guided right-sided double-lumen tubeA 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. | Device | Video-guided right-sided double-lumen tube |
| Conventional right-sided double-lumen tubeA 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. | Device | Conventional right-sided double-lumen tube |
Primary outcome
Successful initial right-sided double-lumen tube placement
Time frame: 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.
7 secondary outcomes
Incidence of right upper-lobe bronchial obstruction
Time frame: After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).
Incidence of intraoperative double-lumen tube displacement
Time frame: From initiation of one-lung ventilation until completion of one-lung ventilation.
Incidence of hypoxemia during one-lung ventilation
Time frame: During one-lung ventilation.
Requirement for rescue fibreoptic bronchoscopy
Time frame: From completion of initial tube positioning until completion of one-lung ventilation.
Time to satisfactory right-sided double-lumen tube positioning
Time frame: During initial tube placement after anaesthesia induction (approximately 10 minutes).
Quality of operative lung collapse
Time frame: 20 minutes after initiation of one-lung ventilation.
Number of intraoperative double-lumen tube repositioning events
Time frame: From initiation of one-lung ventilation until completion of one-lung ventilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant privacy considerations and the restrictions of the informed consent and ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-guided right-sided double-lumen tube and Conventional right-sided double-lumen tube in people with Thoracoscopic Surgery and Double Lumen Tube Intubation, run by Diansan Su at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heng Wen (+8615158080827, zyyywenheng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful initial right-sided double-lumen tube placement (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.