Lung CancerNCT07467005
Video Double-Lumen Tube for Secondary Pulmonary Resection
A study testing Video Double-Lumen Tube Group and Conventional Double-Lumen Tube Group in people with Lung Cancer and Pulmonary Nodule, run by Zhejiang University at 3 sites in China.
Trial summary
During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pulmonary Nodule
- What is being tested?
- Video Double-Lumen Tube Group and Conventional Double-Lumen Tube Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesChina
- Study dates
- 16 Mar 2026to 5 Dec 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
- Age ≥18 years.
- History of previous pulmonary resection.
- Scheduled for elective pulmonary surgery.
- Planned to receive a left-sided double-lumen tube.
- ASA physical status I-III.
- Patients have signed the informed consent form.
Who cannot join
- Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).
- Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.
- Uncontrolled asthma.
- Confirmed pregnancy or current breastfeeding.
- Multiple traumatic injuries.
- Current participation in another clinical trial.
- Other conditions deemed unsuitable by the investigator.
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
Diansan Su, +86 18616514088, diansansu@yahoo.com
Zhejiang Cancer hospital
Hangzhou, Zhejiang, 310000
Pingbo Xu, +86 15700074964, xupingboshanghai@163.com
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Jianhong Xu, +86 17280781160, 1197058@zju.edu.cn
About this study
Official title: Video Double-Lumen Tube for Secondary Pulmonary Resection: A Multicenter Randomized Controlled Trial
During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.
- Conditions
- Lung Cancer, Pulmonary Nodule
- Being tested
- Video Double-Lumen Tube Group, Conventional Double-Lumen Tube Group
- Keywords
- First-attempt Intubation Success Rate, One-lung Ventilation, video double-lumen tube, secondary pulmonary resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Double-Lumen Tube GroupDevice
Use the video double-lumen tube to perform left bronchial intubation under real-time visualization and continuously monitor its position.
Conventional Double-Lumen Tube GroupDevice
Insert a conventional left-sided double-lumen tube using standard intubation techniques.
| Study group | Role | What they receive |
|---|---|---|
| Video Double-Lumen Tube Group | Experimental | Not described Receives: Device: Video Double-Lumen Tube Group |
| Conventional Double-Lumen Tube | Active comparator | Not described Receives: Device: Conventional Double-Lumen Tube Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first-attempt bronchial intubation
Measured: During the first intubation attempt
Secondary outcomes (6)
Intubation time
Measured: Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position
Requirement for and number of fiberoptic bronchoscopy uses
Measured: During the entire intraoperative period
Frequency of intraoperative tube repositioning
Measured: During the entire intraoperative period
Surgeon's rating of lung collapse quality
Measured: During the entire intraoperative period
Incidence of difficult intubation
Measured: At the time of intubation
Intubation-related adverse events
Measured: From the start of intubation until 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion5 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467005
- Sponsor's protocol ID
- ZJU2025B0593
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Double-Lumen Tube for Secondary Pulmonary Resection: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07467005
- Acronym / sponsor ID
- ZJU2025B0593
- Conditions
- Lung Cancer, Pulmonary Nodule
- Keywords
- First-attempt Intubation Success Rate, One-lung Ventilation, video double-lumen tube, secondary pulmonary resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 5 Dec 2027 (estimated)
- First posted
- 12 Mar 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.
During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Double-Lumen Tube Group | Experimental | Device: Video Double-Lumen Tube Group |
| Conventional Double-Lumen Tube | Active comparator | Device: Conventional Double-Lumen Tube Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- History of previous pulmonary resection.
- Scheduled for elective pulmonary surgery.
- Planned to receive a left-sided double-lumen tube.
- ASA physical status I-III.
Key exclusion criteria (7 listed)
- Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).
- Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.
- Uncontrolled asthma.
- Confirmed pregnancy or current breastfeeding.
- Multiple traumatic injuries.
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 Double-Lumen Tube GroupUse the video double-lumen tube to perform left bronchial intubation under real-time visualization and continuously monitor its position. | Device | Video Double-Lumen Tube Group |
| Conventional Double-Lumen Tube GroupInsert a conventional left-sided double-lumen tube using standard intubation techniques. | Device | Conventional Double-Lumen Tube |
Primary outcome
Success rate of first-attempt bronchial intubation
Time frame: During the first intubation attempt
6 secondary outcomes
Intubation time
Time frame: Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position
Requirement for and number of fiberoptic bronchoscopy uses
Time frame: During the entire intraoperative period
Frequency of intraoperative tube repositioning
Time frame: During the entire intraoperative period
Surgeon's rating of lung collapse quality
Time frame: During the entire intraoperative period
Incidence of difficult intubation
Time frame: At the time of intubation
Intubation-related adverse events
Time frame: From the start of intubation until 24 hours postoperatively
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 12 Mar 2026.
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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 Double-Lumen Tube Group and Conventional Double-Lumen Tube Group in people with Lung Cancer and Pulmonary Nodule, run by Zhejiang University 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 6 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: opening soon, as of the sponsor's last update on 12 Mar 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 Diansan Su (+86 18616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of first-attempt bronchial intubation (time frame: During the first intubation attempt). 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 12 Mar 2026.