- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07057531
- Original Trial
Tubeless VATS for Lung Cancer Surgery
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Guangzhou, China
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tubeless group
|
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.
|
|
Other: Intubation group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Intraoperative period (from anesthesia induction to the end of surgery, approximately 1 to 3 hours)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMU-TUBELESS-VATS-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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