跳至主要内容
临床试验/NCT07057531
NCT07057531已完成不适用

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

The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2025年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Lung Injury Assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Tubeless group

Experimental

干预措施: Tubeless thoracic surgery (Procedure)

Intubation group

Other

干预措施: Tubeless thoracic surgery (Procedure)

结局指标

主要结局

Lung Injury Assessment

时间窗: 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.

Lung Injury Assessment

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
The First Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianxing He

Professor

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

Loading locations...

相似试验