LungNCT07057531
Tubeless VATS for Lung Cancer Surgery
A study testing Tubeless thoracic surgery in people with Lung and Lung Cancer (NSCLC), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This prospective cohort study evaluates lung injury, long-term clinical outcomes, and environmental impacts of tubeless video-assisted thoracic surgery (VATS) compared with conventional intubated VATS for lung cancer resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung, Lung Cancer (NSCLC), VATS
- What is being tested?
- Tubeless thoracic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients aged ≥18 years scheduled for elective video-assisted thoracic surgery (VATS) for confirmed or suspected lung cancer.
- Clinical stage suitable for surgical resection (lobectomy, segmentectomy, or wedge resection).
- American Society of Anesthesiologists (ASA) physical status classification ≤III.
- Ability to understand and willingness to provide written informed consent.
- Agreement to adhere to scheduled postoperative clinical follow-up assessments, including pulmonary function tests and survival status evaluations.
Who cannot join
- Patients requiring bilateral pulmonary procedures or planned open thoracotomy.
- History of severe cardiopulmonary disease or unstable medical conditions that contraindicate minimally invasive thoracic surgery.
- Emergency surgery due to acute respiratory or cardiovascular instability.
- Inability to cooperate with the planned anesthetic and surgical protocols or postoperative follow-up procedures.
- Pregnancy or lactation at the time of enrollment.
- Known allergy or contraindication to anesthetic agents or materials used in the study.
- Enrollment in another interventional clinical study within the past 30 days.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou
About this study
Official title: A Prospective Randomized Controlled Study Evaluating Lung Injury, Long-term Clinical Outcomes, and Environmental Impact of Tubeless Versus Intubated Video-Assisted Thoracic Surgery for Lung Cancer Resection
This prospective cohort study evaluates lung injury, long-term clinical outcomes, and environmental impacts of tubeless video-assisted thoracic surgery (VATS) compared with conventional intubated VATS for lung cancer resection. The study aims to determine whether the tubeless approach reduces anesthetic exposure, minimizes lung injury, enhances patient recovery, and decreases carbon emissions, contributing toward sustainable surgical practices.
Read the detailed description
Minimally invasive thoracic surgery typically relies on general anesthesia with endotracheal intubation and mechanical ventilation, practices associated with increased anesthetic exposure, ventilator-induced lung injury, and environmental burden due to anesthetic gas emissions. To address these issues, our research group developed the tubeless VATS technique, employing spontaneous ventilation under monitored anesthesia care with supraglottic airway devices, nerve blocks, and minimal use of opioids and volatile anesthetics.
This multicenter study prospectively enrolls patients undergoing elective lung cancer resection via either tubeless or conventional intubated VATS, following a standardized protocol. The primary objectives include assessing the incidence and severity of lung injury using mechanical power metrics derived from a validated machine-learning model, quantifying anesthetic drug usage, evaluating postoperative recovery and complication rates, and analyzing long-term clinical outcomes including overall survival and quality of life measures.
Additionally, the study investigates the environmental impact of each anesthesia method by quantifying reductions in carbon emissions associated with decreased consumption of inhalational anesthetics. Findings from this research could significantly influence clinical practice guidelines by demonstrating the benefits of tubeless VATS in enhancing patient safety, improving long-term clinical outcomes, and advancing sustainable surgical practices.
- Conditions
- Lung, Lung Cancer (NSCLC), VATS
- Being tested
- Tubeless thoracic surgery
- Keywords
- VATS, Tubeless, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubeless thoracic surgeryProcedure or surgery
Tubeless thoracic surgery is a minimally invasive procedure performed without tracheal intubation or mechanical ventilation, allowing for spontaneous breathing. Anesthesia combines conscious sedation with local nerve blocks to ensure pain relief while preserving diaphragmatic movement. The surgical approach is similar to conventional video-assisted thoracic surgery (VATS), used for procedures like lung resections and mediastinal mass excisions. Post-operative care focuses on early mobilization and quick discharge.
| Study group | Role | What they receive |
|---|---|---|
| Tubeless group | Experimental | Not described Receives: Procedure: Tubeless thoracic surgery |
| Intubation group | Other | Not described Receives: Procedure: Tubeless thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Injury Assessment
Comparison of intraoperative mechanical power (MP) between tubeless and intubated VATS groups, quantified by a validated machine-learning model to evaluate ventilator-induced lung injury severity. Lower mechanical power indicates reduced lung stress and potential lung injury.
Measured: Intraoperative period (from anesthesia induction to the end of surgery, approximately 1 to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start25 Jul 2025
- Primary completion5 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057531
- Sponsor's protocol ID
- GMU-TUBELESS-VATS-2025
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Evaluating Lung Injury, Long-term Clinical Outcomes, and Environmental Impact of Tubeless Versus Intubated Video-Assisted Thoracic Surgery for Lung Cancer Resection
- ClinicalTrials.gov ID
- NCT07057531
- Acronym / sponsor ID
- GMU-TUBELESS-VATS-2025
- Conditions
- Lung, Lung Cancer (NSCLC), VATS
- Keywords
- VATS, Tubeless, NSCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 10 Jul 2025 (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 prospective cohort study evaluates lung injury, long-term clinical outcomes, and environmental impacts of tubeless video-assisted thoracic surgery (VATS) compared with conventional intubated VATS for lung cancer resection. The study aims to determine whether the tubeless approach reduces anesthetic exposure, minimizes lung injury, enhances patient recovery, and decreases carbon emissions, contributing toward sustainable surgical practices.
Detailed description
Minimally invasive thoracic surgery typically relies on general anesthesia with endotracheal intubation and mechanical ventilation, practices associated with increased anesthetic exposure, ventilator-induced lung injury, and environmental burden due to anesthetic gas emissions. To address these issues, our research group developed the tubeless VATS technique, employing spontaneous ventilation under monitored anesthesia care with supraglottic airway devices, nerve blocks, and minimal use of opioids and volatile anesthetics.
This multicenter study prospectively enrolls patients undergoing elective lung cancer resection via either tubeless or conventional intubated VATS, following a standardized protocol. The primary objectives include assessing the incidence and severity of lung injury using mechanical power metrics derived from a validated machine-learning model, quantifying anesthetic drug usage, evaluating postoperative recovery and complication rates, and analyzing long-term clinical outcomes including overall survival and quality of life measures.
Additionally, the study investigates the environmental impact of each anesthesia method by quantifying reductions in carbon emissions associated with decreased consumption of inhalational anesthetics. Findings from this research could significantly influence clinical practice guidelines by demonstrating the benefits of tubeless VATS in enhancing patient safety, improving long-term clinical outcomes, and advancing sustainable surgical practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubeless group | Experimental | Procedure: Tubeless thoracic surgery |
| Intubation group | Other | Procedure: Tubeless thoracic surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥18 years scheduled for elective video-assisted thoracic surgery (VATS) for confirmed or suspected lung cancer.
- Clinical stage suitable for surgical resection (lobectomy, segmentectomy, or wedge resection).
- American Society of Anesthesiologists (ASA) physical status classification ≤III.
- Ability to understand and willingness to provide written informed consent.
- Agreement to adhere to scheduled postoperative clinical follow-up assessments, including pulmonary function tests and survival status evaluations.
Key exclusion criteria (7 listed)
- Patients requiring bilateral pulmonary procedures or planned open thoracotomy.
- History of severe cardiopulmonary disease or unstable medical conditions that contraindicate minimally invasive thoracic surgery.
- Emergency surgery due to acute respiratory or cardiovascular instability.
- Inability to cooperate with the planned anesthetic and surgical protocols or postoperative follow-up procedures.
- Pregnancy or lactation at the time of enrollment.
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 |
|---|---|---|
| Tubeless thoracic surgeryTubeless thoracic surgery is a minimally invasive procedure performed without tracheal intubation or mechanical ventilation, allowing for spontaneous breathing. Anesthesia combines conscious sedation with local nerve blocks to ensure pain relief while preserving diaphragmatic movement. The surgical approach is similar to conventional video-assisted thoracic surgery (VATS), used for procedures like lung resections and mediastinal mass excisions. Post-operative care focuses on early mobilization and quick discharge. | Procedure or surgery | Intubation group, Tubeless group |
Primary outcome
Lung Injury Assessment
Time frame: Intraoperative period (from anesthesia induction to the end of surgery, approximately 1 to 3 hours)
Comparison of intraoperative mechanical power (MP) between tubeless and intubated VATS groups, quantified by a validated machine-learning model to evaluate ventilator-induced lung injury severity. Lower mechanical power indicates reduced lung stress and potential lung injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubeless thoracic surgery in people with Lung and Lung Cancer (NSCLC), run by The First Affiliated Hospital of Guangzhou Medical University 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 5 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Injury Assessment (time frame: Intraoperative period (from anesthesia induction to the end of surgery, approximately 1 to 3 hours)). 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 19 Dec 2025.