Pulmonary Nodules, Early Stage Lung Cancer (I and II), Thoracoscopic Surgery, Sublobar Resection
Conditions
Keywords
Tubeless Surgery, Non-intubated Anesthesia, Enhanced Recovery After Surgery, Sublobar resection, Wedge Resection, Segmentectomy
Brief 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.
Interventions
DEVICELaryngeal Mask Airway
Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
DRUGThoracic Paravertebral Block with Local Anesthetic
Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
PROCEDURENon-intubated Anesthesia
General anesthesia with spontaneous ventilation without endotracheal intubation.
DEVICEDouble-lumen Endotracheal Tube
Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
DEVICEChest Tube Drainage
Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the interventions (anesthesia and drainage strategies), blinding of the participants or the care providers is not feasible. However, the outcome assessors will be blinded to the group assignment.
Intervention model description
This is a prospective, randomized, open-label, parallel-group, single-center trial with a 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications (Clavien-Dindo classification) | From surgery until 30 days after discharge | Incidence and severity of postoperative complications classified according to the Clavien-Dindo classification, including pneumothorax, atelectasis, and pleural effusion requiring intervention. |
Countries
China
Contacts
CONTACTJianxing He, Ph.D
Outcome results
None listed