Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- 24-hour high-quality recovery rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tubeless Strategy Group
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.
干预措施: Laryngeal Mask Airway (Device)
Tubeless Strategy Group
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.
干预措施: Thoracic Paravertebral Block with Local Anesthetic (Drug)
Tubeless Strategy Group
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.
干预措施: Non-intubated Anesthesia (Procedure)
Traditional Strategy Group
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.
干预措施: Double-lumen Endotracheal Tube (Device)
Traditional Strategy Group
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.
干预措施: Chest Tube Drainage (Device)
结局指标
主要结局
24-hour high-quality recovery rate
时间窗: 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.
次要结局
- Postoperative complications (Clavien-Dindo classification)(From surgery until 30 days after discharge)
研究者
Jianxing He
Professor of Thoracic Surgery
The First Affiliated Hospital of Guangzhou Medical University