Pulmonary NodulesNCT07719959
A Randomized Controlled Trial of 3D Airway Reconstruction for Precise Double-Lumen Bronchial Intubation
A study testing 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation and Gender and Height-Based Double-Lumen Tube Selection in people with Pulmonary Nodules, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Nodules
- What is being tested?
- 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation and Gender and Height-Based Double-Lumen Tube Selection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2026to Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ①Aged 18-75 years, undergoing elective VATS thoracic surgery, with DLT during the procedure; ②ASA physical status I-III; ③ Preoperative chest CT data available for 3D reconstruction; ④ Agree to participate in this study and voluntarily sign the informed consent form.
Who cannot join
- ① Preoperative presence of severe respiratory diseases, such as severe chronic obstructive pulmonary disease (COPD), pulmonary infection, and asthma exacerbation; ② Clinically assessed as a difficult airway, such as limited head tilt, spinal deformity, airway or head and neck masses, significant abnormalities in airway anatomy, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Qianmei Zhu, MD, PhD, 86-18810651253, zhuqm661@163.com
About this study
Official title: A Randomized Controlled Clinical Study on the Precise Positioning of Double-lumen Bronchial Intubation Guided by Medical Imaging-based Airway Three-dimensional Reconstruction Technology
This is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby reducing the rate of intubation failure and the occurrence of perioperative adverse events to a certain extent.
- Conditions
- Pulmonary Nodules
- Being tested
- 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation, Gender and Height-Based Double-Lumen Tube Selection
- Keywords
- Thoracic Surgery, Anesthetic Management, Double-Lumen Tube Intubation, Chest CT, 3D Airway Reconstruction
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Airway Reconstruction-Guided Double-Lumen Tube IntubationProcedure or surgery
Patients in this group will undergo preoperative chest CT scanning. The DICOM data will be imported into reconstruction software to create a 3D model of the trachea and bronchi. The diameter of the trachea, left and right main bronchus will be measured on the 3D model to select the appropriate size of the double-lumen tube (DLT). The 3D model can also provide suggestions on the depth of intubation and the bifurcation angle of the bronchus. During anesthesia induction, the selected DLT will be inserted based on the measurements derived from the 3D model.
Gender and Height-Based Double-Lumen Tube SelectionProcedure or surgery
Patients in this group will undergo DLT intubation guided by conventional clinical experience. The DLT size will be selected based on the patient's gender and height according to standard clinical formulas or empirical rules. No preoperative 3D airway reconstruction will be performed for tube sizing.
| Study group | Role | What they receive |
|---|---|---|
| 3D Airway Reconstruction Group | Experimental | Not described Receives: Procedure: 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation |
| Clinical Experience Group | Active comparator | Not described Receives: Procedure: Gender and Height-Based Double-Lumen Tube Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first intubation without the use of fiberoptic bronchoscope
The success rate of first intubation without using a fiberoptic bronchoscope is defined as follows: if no adjustment or only minor adjustment of less than 5mm is required after fiberoptic bronchoscopy, and any of the following criteria is met, it is considered unsuccessful: ① difficult insertion, requiring a change in the size of the double-lumen tube or other methods of pulmonary isolation; ② insertion into the opposite main bronchus; ③ bronchial cuff protruding into the carina (more than 50% of the cuff); ④ the edge of the bronchial cuff cuff is not visible at the entrance of the bronchus; ⑤ covering more than 50% of the opening of the right upper lung; ⑥ fiberoptic bronchoscopy cannot distinguish between tracheal/bronchial anatomical structures.
Measured: Perioperative
Secondary outcomes (8)
Intubation duration
Measured: Perioperative
The incidence of switching to a different DLT size or adopting alternative intubation techniques
Measured: Perioperative
Intraoperative airway pressure
Airway peak pressure, plateau pressure, and compliance during supine dual lung ventilation and lateral single lung ventilation
Measured: Perioperative
Surgeon satisfaction with lung collapse
The surgeon satisfaction scale for lung collapse is a commonly used evaluation tool in clinical trials. The scale consists of 11 numbers from 0 to 10, representing varying degrees of satisfaction among surgeons regarding the effect of lung collapse. 0 indicates "very dissatisfied", and the satisfaction level increases progressively, with 10 indicating "very satisfied".
Measured: Perioperative
Incidence of sore throat
Measured: Perioperative and day 1
Incidence of hoarseness
Measured: Perioperative and day 1
Incidence of hypoxemia
Measured: Perioperative
DLT adjustment rate under fiberoptic bronchoscopy in lateral position
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start14 Aug 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZIJIA LIU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719959
- Sponsor's protocol ID
- K8513
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study on the Precise Positioning of Double-lumen Bronchial Intubation Guided by Medical Imaging-based Airway Three-dimensional Reconstruction Technology
- ClinicalTrials.gov ID
- NCT07719959
- Acronym / sponsor ID
- K8513
- Conditions
- Pulmonary Nodules
- Keywords
- Thoracic Surgery, Anesthetic Management, Double-Lumen Tube Intubation, Chest CT, 3D Airway Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Jul 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 is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby reducing the rate of intubation failure and the occurrence of perioperative adverse events to a certain extent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Airway Reconstruction Group | Experimental | Procedure: 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation |
| Clinical Experience Group | Active comparator | Procedure: Gender and Height-Based Double-Lumen Tube Selection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ①Aged 18-75 years, undergoing elective VATS thoracic surgery, with DLT during the procedure; ②ASA physical status I-III; ③ Preoperative chest CT data available for 3D reconstruction; ④ Agree to participate in this study and voluntarily sign the informed consent form.
Key exclusion criteria (1 listed)
- ① Preoperative presence of severe respiratory diseases, such as severe chronic obstructive pulmonary disease (COPD), pulmonary infection, and asthma exacerbation; ② Clinically assessed as a difficult airway, such as limited head tilt, spinal deformity, airway or head and neck masses, significant abnormalities in airway anatomy, etc.
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 |
|---|---|---|
| 3D Airway Reconstruction-Guided Double-Lumen Tube IntubationPatients in this group will undergo preoperative chest CT scanning. The DICOM data will be imported into reconstruction software to create a 3D model of the trachea and bronchi. The diameter of the trachea, left and right main bronchus will be measured on the 3D model to select the appropriate size of the double-lumen tube (DLT). The 3D model can also provide suggestions on the depth of intubation and the bifurcation angle of the bronchus. During anesthesia induction, the selected DLT will be inserted based on the measurements derived from the 3D model. | Procedure or surgery | 3D Airway Reconstruction Group |
| Gender and Height-Based Double-Lumen Tube SelectionPatients in this group will undergo DLT intubation guided by conventional clinical experience. The DLT size will be selected based on the patient's gender and height according to standard clinical formulas or empirical rules. No preoperative 3D airway reconstruction will be performed for tube sizing. | Procedure or surgery | Clinical Experience Group |
Primary outcome
Success rate of first intubation without the use of fiberoptic bronchoscope
Time frame: Perioperative
The success rate of first intubation without using a fiberoptic bronchoscope is defined as follows: if no adjustment or only minor adjustment of less than 5mm is required after fiberoptic bronchoscopy, and any of the following criteria is met, it is considered unsuccessful: ① difficult insertion, requiring a change in the size of the double-lumen tube or other methods of pulmonary isolation; ② insertion into the opposite main bronchus; ③ bronchial cuff protruding into the carina (more than 50% of the cuff); ④ the edge of the bronchial cuff cuff is not visible at the entrance of the bronchus; ⑤ covering more than 50% of the opening of the right upper lung; ⑥ fiberoptic bronchoscopy cannot distinguish between tracheal/bronchial anatomical structures.
8 secondary outcomes
Intubation duration
Time frame: Perioperative
The incidence of switching to a different DLT size or adopting alternative intubation techniques
Time frame: Perioperative
Intraoperative airway pressure
Time frame: Perioperative
Surgeon satisfaction with lung collapse
Time frame: Perioperative
Incidence of sore throat
Time frame: Perioperative and day 1
Incidence of hoarseness
Time frame: Perioperative and day 1
Incidence of hypoxemia
Time frame: Perioperative
DLT adjustment rate under fiberoptic bronchoscopy in lateral position
Time frame: Perioperative
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation and Gender and Height-Based Double-Lumen Tube Selection in people with Pulmonary Nodules, run by Peking Union Medical College Hospital at 1 site 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 1 inclusion and 1 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 2 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 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of first intubation without the use of fiberoptic bronchoscope (time frame: Perioperative). 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 2 Sep 2026.