NCT07057531

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

December 19, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 30, 2025

Last Update Submit

December 12, 2025

Conditions

VATSLungLung Cancer (NSCLC)

Keywords

VATSTubelessNSCLC

Outcome Measures

Primary Outcomes (1)

  • 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.

    Intraoperative period (from anesthesia induction to the end of surgery, approximately 1 to 3 hours)

Study Arms (2)

Tubeless group

EXPERIMENTAL
Procedure: Tubeless thoracic surgery

Intubation group

OTHER
Procedure: Tubeless thoracic surgery

Interventions

Tubeless thoracic surgeryPROCEDURE

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 groupTubeless group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 10, 2025

Study Start

July 25, 2025

Primary Completion

December 5, 2025

Study Completion

December 12, 2025

Last Updated

December 19, 2025

Record last verified: 2025-06

Locations

CN(1)