Tubeless VATS for Lung Cancer Surgery

NCT ID: NCT07057531

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2025-12-12

Brief Summary

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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

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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

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Lung Lung Cancer (NSCLC) VATS

Keywords

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VATS Tubeless NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Tubeless group

Group Type EXPERIMENTAL

Tubeless thoracic surgery

Intervention Type PROCEDURE

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.

Intubation group

Group Type OTHER

Tubeless thoracic surgery

Intervention Type PROCEDURE

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.

Interventions

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Tubeless thoracic 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients aged ≥18 years scheduled for elective video-assisted thoracic surgery (VATS) for confirmed or suspected lung cancer.
2. Clinical stage suitable for surgical resection (lobectomy, segmentectomy, or wedge resection).
3. American Society of Anesthesiologists (ASA) physical status classification ≤III.
4. Ability to understand and willingness to provide written informed consent.
5. Agreement to adhere to scheduled postoperative clinical follow-up assessments, including pulmonary function tests and survival status evaluations.

Exclusion Criteria

1. Patients requiring bilateral pulmonary procedures or planned open thoracotomy.
2. History of severe cardiopulmonary disease or unstable medical conditions that contraindicate minimally invasive thoracic surgery.
3. Emergency surgery due to acute respiratory or cardiovascular instability.
4. Inability to cooperate with the planned anesthetic and surgical protocols or postoperative follow-up procedures.
5. Pregnancy or lactation at the time of enrollment.
6. Known allergy or contraindication to anesthetic agents or materials used in the study.
7. Enrollment in another interventional clinical study within the past 30 days.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianxing He

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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GMU-TUBELESS-VATS-2025

Identifier Type: -

Identifier Source: org_study_id