The First Affiliated Hospital of Guangzhou Medical University
Phase
Not applicable
Started
2026-02-01
Last updated
2026-02-13
Condition(s) studied
Pulmonary NodulesEarly Stage Lung Cancer (I and II)Thoracoscopic SurgerySublobar Resection
Investigational drug(s) / intervention(s)
Laryngeal Mask AirwayThoracic Paravertebral Block with Local AnestheticNon-intubated AnesthesiaDouble-lumen Endotracheal TubeChest Tube Drainage
Laryngeal Mask Airway: Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
Thoracic Paravertebral Block with Local Anesthetic: Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
Non-intubated Anesthesia: General anesthesia with spontaneous ventilation without endotracheal intubation.
Double-lumen Endotracheal Tube: Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
Chest Tube Drainage: Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.
Study summary
This is a prospective, randomized controlled clinical trial conducted at a single center. The study aims to evaluate whether a "tubeless" strategy can enhance recovery for patients undergoing minimally invasive thoracoscopic sublobar resection (wedge or segment resection) for small lung nodules.
Participants will be randomly assigned to one of two groups:
* The experimental group will receive the "tubeless" strategy, which includes non-endotracheal intubation anesthesia (using a laryngeal mask) and no routine chest tube drainage after surgery.
* The control group will receive the traditional strategy, which includes double-lumen endotracheal intubation anesthesia and routine chest tube drainage.
The main goal is to compare the rate of achieving high-quality fast-track recovery at 24 hours after surgery between the two groups. This study will provide evidence on whether the tubeless approach can help patients recover faster and more comfortably without compromising safety.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 18 and 75 years.
* Scheduled for uniportal or multiportal video-assisted thoracoscopic surgery (VATS) for sublobar resection (wedge or segmentectomy).
* Presence of peripheral lung nodules ≤ 2 cm in diameter and ≤ 2 cm from the pleura, confirmed by CT scan.
* Ability to understand and provide written informed consent.
* American Society of Anesthesiologists (ASA) physical status I-III.
Exclusion Criteria:
* Severe pleural adhesions or fibrosis that would preclude non-intubated anesthesia or tubeless approach.
* Severe cardiopulmonary dysfunction: FEV1 \< 50% predicted, DLCO \< 60% predicted, heart failure (NYHA class III-IV), or unstable angina.
* Pregnancy or lactation (confirmed by urine test if applicable).
* Inability to tolerate one-lung ventilation due to anatomical or physiological reasons.
* History of ipsilateral thoracic surgery.
* Active pulmonary infection, uncontrolled diabetes, or other comorbidities that increase surgical risk.
* Participation in another interventional trial within 30 days.
Primary outcome measure(s)
24-hour high-quality recovery rate — 24 hours after surgery Composite endpoint defined as meeting all of the following criteria at 24 hours postoperatively: (1) meeting standardized discharge criteria (stable vital signs, controlled pain, autonomous ambulation); (2) Quality of Recovery-15 (QoR-15) score ≥130 (range 0-150; higher scores indicate better recovery); and (3) absence of Clavien-Dindo grade ≥II respiratory complications.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of GZMU
Guangzhou
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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