NCT07409129

Tubeless Strategy for Enhanced Recovery After Sublobar Resection

Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open-label, randomized controlled trial with a 1:1 allocation ratio. Adult patients (aged 18-75) scheduled for uniportal VATS sublobar resection for peripheral lung nodules (≤2 cm, ≤2 cm from the pleura) will be assessed for eligibility. Key exclusion criteria include severe pleural adhesions, inability to achieve selective lung ventilation, and severe cardiopulmonary dysfunction. The primary outcome is a composite endpoint measuring the rate of high-quality fast-track recovery at 24 hours postoperatively, defined as simultaneously meeting all three criteria: 1) meeting standardized discharge criteria, 2) a QoR-15 (Quality of Recovery-15) score ≥130, and 3) absence of Clavien-Dindo grade ≥II respiratory adverse events until the first follow-up. Secondary outcomes include individual components of the primary endpoint, pneumothorax rate, postoperative pain scores, time to first ambulation, length of hospital stay, hospitalization costs, and patient satisfaction. A sample size of 138 participants (69 per group) was calculated to provide sufficient statistical power. Data analysis will follow the intention-to-treat principle.

Conditions

• Pulmonary Nodules
• Early Stage Lung Cancer (I and II)
• Thoracoscopic Surgery
• Sublobar Resection

Interventions

Type	Name	Description
DEVICE	Laryngeal Mask Airway	Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
DRUG	Thoracic Paravertebral Block with Local Anesthetic	Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
PROCEDURE	Non-intubated Anesthesia	General anesthesia with spontaneous ventilation without endotracheal intubation.
DEVICE	Double-lumen Endotracheal Tube	Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
DEVICE	Chest Tube Drainage	Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: China