Video Double-Lumen Tube for Secondary Pulmonary Resection: A Multicenter 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
- 500
- 试验地点
- 3
- 主要终点
- Success rate of first-attempt bronchial intubation
研究概览
简要总结
During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •History of previous pulmonary resection.
- •Scheduled for elective pulmonary surgery.
- •Planned to receive a left-sided double-lumen tube.
- •ASA physical status I-III.
- •Patients have signed the informed consent form.
排除标准
- •Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).
- •Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.
- •Uncontrolled asthma.
- •Confirmed pregnancy or current breastfeeding.
- •Multiple traumatic injuries.
- •Current participation in another clinical trial.
- •Other conditions deemed unsuitable by the investigator.
研究组 & 干预措施
Video Double-Lumen Tube Group
干预措施: Video Double-Lumen Tube Group (Device)
Conventional Double-Lumen Tube
干预措施: Conventional Double-Lumen Tube Group (Device)
结局指标
主要结局
Success rate of first-attempt bronchial intubation
时间窗: During the first intubation attempt
次要结局
- Requirement for and number of fiberoptic bronchoscopy uses(During the entire intraoperative period)
- Frequency of intraoperative tube repositioning(During the entire intraoperative period)
- Surgeon's rating of lung collapse quality(During the entire intraoperative period)
- Incidence of difficult intubation(At the time of intubation)
- Intubation time(Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position)
- Intubation-related adverse events(From the start of intubation until 24 hours postoperatively)
研究者
Diansan Su
Chief Physician,Researcher
Zhejiang University