Effect of Inspired Oxygen Concentration on Postoperative Atelectasis in Patients Undergoing Elective Thoracoscopic Pulmonary Lobectomy Based on Perioperative Lung Protection Strategy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Non-operated lung atelectasis volume percentage
研究概览
简要总结
This study aims to investigate whether using 50% FiO₂ during one-lung ventilation, compared with 100% FiO₂, reduces postoperative atelectasis in the non-dependent (healthy) lung of patients undergoing VATS pulmonary lobectomy, based on individualized PEEP titration. This is a single-center, prospective, assessor- and patient-blinded randomized controlled trial. A total of 100 patients (50 per group, including a pilot phase of 10 per group) will be enrolled and randomized 1:1 to the high-oxygen group (FiO₂=100%) and the low-oxygen group (FiO₂=50%). The primary endpoint is the percentage of atelectasis volume in the non-operated lung relative to the total non-operated lung volume, assessed by CT at 60±10 minutes after tracheal extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients are blinded pre- and postoperatively; postoperative data collectors, CT readers, and biostatisticians are blinded to allocation; only the attending anesthesiologist is unblinded due to the nature of the intervention (setting FiO₂), but does not participate in data collection or outcome assessment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years Elective thoracoscopic (VATS) pulmonary lobectomy Anticipated one-lung ventilation duration >1 hour ASA physical status I-III
排除标准
- •Previous pulmonary surgery (including lobectomy, lung volume reduction surgery, or other lung resection) Pre-existing significant atelectasis (large collapse on preoperative CT) Contraindications to PEEP: intracranial hypertension, bronchopleural fistula, hypovolemic shock, right heart failure, giant bullae, pneumothorax Preoperative continuous oxygen therapy or mechanical ventilation, moderate-severe COPD BMI ≥ 30 kg/m² Ischemic cardiovascular and cerebrovascular diseases, such as myocardial infarction, ischemic stroke, and patients with coronary or cerebrovascular stents Patient refusal to participate
- •Withdrawal Criteria / Major Protocol Deviations:
- •Surgery changed to simple wedge resection Severe pleural adhesions (found intraoperatively) One-lung ventilation duration < 50 minutes Intraoperative blood loss > 500 ml Severe hypotension (MAP < 55 mmHg despite high-dose vasopressors) Unexpected non-thoracic surgical procedure Ventilation protocol interrupted (e.g., FiO₂ exposure < 80% of planned time in the low-oxygen group) Postoperative CT not completed or image quality unusable Subject withdrawal of informed consent
研究组 & 干预措施
High-Oxygen Group (FiO₂=100%)
FiO₂=100% throughout one-lung ventilation.
干预措施: High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion (Procedure)
Low-Oxygen Group (FiO₂=50%)
Initial FiO₂=50% during one-lung ventilation (maintaining SpO₂≥92%) with individualized PEEP titration. If SpO₂<92%, increase FiO₂ by 10% increments; if SpO₂<90% and FiO₂ already at 100%, initiate rescue ventilation.
干预措施: Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation (Procedure)
结局指标
主要结局
Non-operated lung atelectasis volume percentage
时间窗: CT scans were performed at 60 ± 10 minutes after tracheal extubation to assess the volume ratio of atelectasis in the contralateral lung.
Chest CT at 60±10 minutes after tracheal extubation
次要结局
- Incidence of postoperative pulmonary complications(Postoperative days 1-3)
- QoR-15 quality of recovery score(Postoperative days 1-3)
- Arterial blood gas analysis (oxygenation index)(Multiple time points: preop room air; 5 minutes after one lung ventilation start; 1 hour after one lung ventilation ; pre-postanesthesia care unit discharge)
- Intraoperative oxygen saturationo(Intraoperative (during one lung ventilation))
- Oxygen concentration exposure burden(Intraoperative (during one lung ventilation))
- Incidence of intraoperative adverse events(During surgery)
- Oxidative stress marker (MDA)(1 hour after one lung ventilation)
- Arterial blood gas analysis (oxygenation index)(Multiple time points: (1) preoperative preparation room; (2) 5 minutes after two-lung ventilation at induction; (3) 5 minutes after one-lung ventilation start; (4) 1 hour after one-lung ventilation; (5) 10 minutes after tracheal extubation)
- Intraoperative oxygen saturation(Intraoperative (during one lung ventilation))
- Incidence of intraoperative adverse events(Intraoperative (from induction to emergence))
- Postoperative renal function (serum creatinine and eGFR)(Postoperative days 1 and 3)
研究者
Yi Feng, MD
Director of Anesthesiology
Peking University People's Hospital