Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial
| Registry | NCT07409129 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 138 (Estimated) |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University (Other) |
| Conditions | Pulmonary Nodules, Early Stage Lung Cancer (I and II), Thoracoscopic Surgery, Sublobar Resection |
| Interventions | Laryngeal Mask Airway, Thoracic Paravertebral Block with Local Anesthetic, Non-intubated Anesthesia, Double-lumen Endotracheal Tube, Chest Tube Drainage (Device, drug, procedure) |
| Dates | start 2026-02-01 (estimated), primary completion 2026-06-01 (estimated), completion 2026-09-01 (estimated), first posted 2026-02-13, last updated 2026-02-13 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Pulmonary Nodules All trials for Early Stage Lung Cancer (I and II) All trials of Laryngeal Mask Airway All trials of Thoracic Paravertebral Block with Local Anesthetic
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tubeless Strategy Group | Experimental | Device: Laryngeal Mask Airway; Drug: Thoracic Paravertebral Block with Local Anesthetic; Procedure: Non-intubated Anesthesia | Participants in this arm receive the tubeless strategy: * Anesthesia: Laryngeal mask airway with spontaneous ventilation (non-intubated). * Drainage: No chest tube placement after surgery * Goal: To enhance recovery by minimizing invasive procedures. |
| Traditional Strategy Group | Active comparator | Device: Double-lumen Endotracheal Tube; Device: Chest Tube Drainage | Participants in this arm receive the conventional standard care: * Anesthesia: Double-lumen endotracheal intubation with mechanical ventilation. * Drainage: Routine chest tube drainage with water-seal suction postoperatively. * Follows current clinical guidelines for thoracoscopic sublobar resection. |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital of GZMU | Guangzhou, China | China |