Tubeless Strategy for Enhanced Recovery After Sublobar Resection

Guangzhou Medical University

Status: Not yet enrolling

Conditions: Sublobar Resection; Thoracoscopic Surgery; Pulmonary Nodules; Early Stage Lung Cancer (I and II)

Treatments: Procedure: Non-intubated Anesthesia; Device: Laryngeal Mask Airway; Device: Chest Tube Drainage; Drug: Thoracic Paravertebral Block with Local Anesthetic; Device: Double-lumen Endotracheal Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT07409129

TL-ERAS-SLR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Tubeless Strategy Group

Experimental group

Description:

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.

Treatment:

Drug: Thoracic Paravertebral Block with Local Anesthetic

Device: Laryngeal Mask Airway

Procedure: Non-intubated Anesthesia

Traditional Strategy Group

Active Comparator group

Description:

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.

Treatment:

Device: Double-lumen Endotracheal Tube

Device: Chest Tube Drainage