About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Laryngeal Mask Airway
DeviceAirway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
Thoracic Paravertebral Block with Local Anesthetic
DrugThoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
Non-intubated Anesthesia
Procedure/SurgeryGeneral anesthesia with spontaneous ventilation without endotracheal intubation.
Double-lumen Endotracheal Tube
DeviceDouble-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
Chest Tube Drainage
DeviceRoutine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.
Treatment groups
Trial outcomes
Primary outcomes
24-hour high-quality recovery rate
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.
Secondary outcomes
Postoperative complications (Clavien-Dindo classification)
Incidence and severity of postoperative complications classified according to the Clavien-Dindo classification, including pneumothorax, atelectasis, and pleural effusion requiring intervention.
Sponsors and contacts
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