Right-sided Double-lumen Tube PositioningNCT07849400
Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
A study testing Continuous video-guided right-sided double-lumen tube and Conventional right-sided double-lumen tube in people with Right-sided Double-lumen Tube Positioning and Lung Isolation During Thoracoscopic Surgery, run by Diansan Su at 3 sites in China.
Trial summary
Right-sided double-lumen tubes are used for lung isolation during thoracoscopic surgery but can be difficult to position because of right bronchial anatomy. This multicenter randomized controlled trial will compare a continuous video-guided right-sided double-lumen tube with a conventional right-sided double-lumen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery, One-lung Ventilation
- What is being tested?
- Continuous 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
- 1 Oct 2026to 30 May 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 (ASA) physical status I-III.
- Patients scheduled for elective thoracoscopic surgery requiring lung isolation with a right-sided double-lumen tube.
- Patients who provide written informed consent.
Who cannot join
- Contraindications to placement of a right-sided double-lumen tube, including right main bronchial lesions that preclude its use.
- Known tracheobronchial anatomical abnormalities.
- Known or anticipated difficult airway.
- Requirement for rapid sequence induction.
- Emergency surgery.
- Thoracic surgery within 4 weeks before enrollment, recent respiratory infection, or known or suspected pulmonary tuberculosis.
- Severe respiratory instability.
- Concurrent participation in another interventional clinical trial that may affect the study outcomes.
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
The First Affiliated Hospital, Zhejiang University School of Medicine,
Hangzhou, Zhejiang, 310000
Research Coordinator, 86057187236169, wen_heng@yeah.net
Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）
Jiaxing, Zhejiang, 314000
Yang Research Coordinator, 8617816519327, mail17816519327@163.com
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Chang Research Coordinator, 8615157300638, 15157300638@163.com
About this study
Official title: Continuous Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Lung Isolation in Thoracoscopic Surgery: A Multicenter Randomized Controlled Trial
Right-sided double-lumen tubes are used for lung isolation during thoracoscopic surgery but can be difficult to position because of right bronchial anatomy. This multicenter randomized controlled trial will compare a continuous video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adult patients undergoing thoracoscopic surgery requiring right-sided lung isolation. The primary objective is to determine whether continuous video guidance increases the rate of successful initial right-sided double-lumen tube positioning. Secondary outcomes include positioning time, clinically relevant intraoperative tube displacement, rescue fiberoptic bronchoscopy, lung collapse quality, hypoxemia during one-lung ventilation, and airway-related complications.
- Conditions
- Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery, One-lung Ventilation, Lung Cancer, Pulmonary Nodules, Mediastinal Tumors
- Being tested
- Continuous video-guided right-sided double-lumen tube, Conventional right-sided double-lumen tube
- Medical subject headings
- Lung Neoplasms, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous video-guided right-sided double-lumen tubeDevice
Participants will receive a continuous video-guided right-sided double-lumen tube for lung isolation during thoracoscopic surgery. The device incorporates an integrated visualization system that provides continuous real-time airway visualization during tube positioning and intraoperative management.
Conventional right-sided double-lumen tubeDevice
Participants will receive a conventional right-sided double-lumen tube for lung isolation during thoracoscopic surgery according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Continuous video-guided right-sided double-lumen tube | Experimental | Not described Receives: Device: Continuous video-guided right-sided double-lumen tube |
| Conventional right-sided double-lumen tube | Active comparator | Not described 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.
Number of participants with successful initial right-sided double-lumen tube positioning assessed by fiberoptic bronchoscopy
Successful initial positioning is defined as Grade 1 (optimal) or Grade 2 (acceptable) tube position at the first protocol-mandated fiberoptic bronchoscopic assessment before any bronchoscopic adjustment. Grade 3 (malposition) is considered unsuccessful. Successful positioning requires an acceptable bronchial cuff position, adequate alignment of the right upper-lobe ventilation slot with the right upper-lobe bronchial orifice, absence of clinically relevant right upper-lobe obstruction, and a patent bronchus intermedius without the need for further advancement, withdrawal, or rotation of the tube. Each participant will be classified as successful or unsuccessful.
Measured: Intraoperatively, immediately after initial tube positioning and before initiation of one-lung ventilation.
Secondary outcomes (5)
Time to initial right-sided double-lumen tube positioning
Time in seconds from passage of the double-lumen tube through the vocal cords into the trachea until the anesthesiologist completes the initial right-sided bronchial positioning and no further tube advancement, withdrawal, or rotation is performed before the protocol-mandated fiberoptic bronchoscopic assessment.
Measured: Periprocedural, during initial right-sided double-lumen tube positioning.
Number of unplanned intraoperative right-sided double-lumen tube repositioning events per participant
An event is defined as any unplanned advancement, withdrawal, rotation, or other repositioning of the right-sided double-lumen tube after satisfactory initial positioning has been confirmed. Minor positional changes not requiring intervention are not counted. For each repositioning event, the use of unplanned fiberoptic bronchoscopy for guidance or confirmation will be recorded as an event characteristic. The total number of repositioning events will be recorded for each participant.
Measured: Intraoperatively, from confirmation of satisfactory initial tube position until completion of one-lung ventilation.
Quality of surgical lung collapse assessed by a 3-point surgeon-rated scale
The operating surgeon will assess the quality of surgical lung collapse using a predefined 3-point ordinal scale: 1 = poor, lung collapse is insufficient and interferes with surgical exposure or requires additional intervention; 2 = moderate, lung collapse is partially adequate with some interference with surgical exposure but without the need for additional intervention; and 3 = good, lung collapse is adequate and does not interfere with surgical exposure. Higher scores indicate better lung collapse.
Measured: Intraoperatively, approximately 20 minutes after initiation of one-lung ventilation.
Number of hypoxemic episodes during one-lung ventilation per participant
A hypoxemic episode is defined as peripheral oxygen saturation (SpO₂) below 90% for at least 1 minute during one-lung ventilation, measured continuously by pulse oximetry. A new hypoxemic episode will be counted only after SpO₂ has recovered to 90% or above for at least 1 minute following the previous episode. The total number of hypoxemic episodes will be recorded for each participant.
Measured: Intraoperatively, during one-lung ventilation.
Airway-related complications
Measured: From airway instrumentation until 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right-sided Double-lumen Tube PositioningStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diansan Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849400
- Sponsor's protocol ID
- ZJU20260827
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be considered in accordance with participant privacy, institutional data governance, applicable ethics requirements, and relevant study policies.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Lung Isolation in Thoracoscopic Surgery: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07849400
- Acronym / sponsor ID
- ZJU20260827
- Conditions
- Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery, One-lung Ventilation, Lung Cancer, Pulmonary Nodules, Mediastinal Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Diansan SuUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 30 Sep 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.
Right-sided double-lumen tubes are used for lung isolation during thoracoscopic surgery but can be difficult to position because of right bronchial anatomy. This multicenter randomized controlled trial will compare a continuous video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adult patients undergoing thoracoscopic surgery requiring right-sided lung isolation. The primary objective is to determine whether continuous video guidance increases the rate of successful initial right-sided double-lumen tube positioning. Secondary outcomes include positioning time, clinically relevant intraoperative tube displacement, rescue fiberoptic bronchoscopy, lung collapse quality, hypoxemia during one-lung ventilation, and airway-related complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous video-guided right-sided double-lumen tube | Experimental | Device: Continuous video-guided right-sided double-lumen tube |
| Conventional right-sided double-lumen tube | Active comparator | Device: Conventional right-sided double-lumen tube |
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 (ASA) physical status I-III.
- Patients scheduled for elective thoracoscopic surgery requiring lung isolation with a right-sided double-lumen tube.
- Patients who provide written informed consent.
Key exclusion criteria (8 listed)
- Contraindications to placement of a right-sided double-lumen tube, including right main bronchial lesions that preclude its use.
- Known tracheobronchial anatomical abnormalities.
- 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 |
|---|---|---|
| Continuous video-guided right-sided double-lumen tubeParticipants will receive a continuous video-guided right-sided double-lumen tube for lung isolation during thoracoscopic surgery. The device incorporates an integrated visualization system that provides continuous real-time airway visualization during tube positioning and intraoperative management. | Device | Continuous video-guided right-sided double-lumen tube |
| Conventional right-sided double-lumen tubeParticipants will receive a conventional right-sided double-lumen tube for lung isolation during thoracoscopic surgery according to standard clinical practice. | Device | Conventional right-sided double-lumen tube |
Primary outcome
Number of participants with successful initial right-sided double-lumen tube positioning assessed by fiberoptic bronchoscopy
Time frame: Intraoperatively, immediately after initial tube positioning and before initiation of one-lung ventilation.
Successful initial positioning is defined as Grade 1 (optimal) or Grade 2 (acceptable) tube position at the first protocol-mandated fiberoptic bronchoscopic assessment before any bronchoscopic adjustment. Grade 3 (malposition) is considered unsuccessful. Successful positioning requires an acceptable bronchial cuff position, adequate alignment of the right upper-lobe ventilation slot with the right upper-lobe bronchial orifice, absence of clinically relevant right upper-lobe obstruction, and a patent bronchus intermedius without the need for further advancement, withdrawal, or rotation of the tube. Each participant will be classified as successful or unsuccessful.
5 secondary outcomes
Time to initial right-sided double-lumen tube positioning
Time frame: Periprocedural, during initial right-sided double-lumen tube positioning.
Number of unplanned intraoperative right-sided double-lumen tube repositioning events per participant
Time frame: Intraoperatively, from confirmation of satisfactory initial tube position until completion of one-lung ventilation.
Quality of surgical lung collapse assessed by a 3-point surgeon-rated scale
Time frame: Intraoperatively, approximately 20 minutes after initiation of one-lung ventilation.
Number of hypoxemic episodes during one-lung ventilation per participant
Time frame: Intraoperatively, during one-lung ventilation.
Airway-related complications
Time frame: From airway instrumentation until 24 hours after surgery.
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be considered in accordance with participant privacy, institutional data governance, applicable ethics requirements, and relevant study policies.
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 Continuous video-guided right-sided double-lumen tube and Conventional right-sided double-lumen tube in people with Right-sided Double-lumen Tube Positioning and Lung Isolation During Thoracoscopic Surgery, 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 8 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: opening soon, as of the sponsor's last update on 30 Sep 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 (+86057187236169, wen_heng@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with successful initial right-sided double-lumen tube positioning assessed by fiberoptic bronchoscopy (time frame: Intraoperatively, immediately after initial tube positioning and before initiation of one-lung ventilation.). 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 30 Sep 2026.