Incidence of Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Postoperative vocal cord palsy
研究概览
简要总结
The goal of this clinical trial is to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.
详细描述
Esophagectomy is a challenging surgery that usually requires one lung ventilation, and double-lumen endobronchial tubes and bronchial blockers are commonly used for one lung ventilation.
Successful resection of recurrent laryngeal nerve lymph nodes during esophagectomy is important to survival and prevention of cancer recurrence, but there is a risk of postoperative vocal cord palsy due to the recurrent laryngeal nerve injury during the resection.
Compared to a double-lumen endobronchial tube, the use of a bronchial blocker is expected to reduce the incidence of recurrent laryngeal nerve injury; however, few clinical studies compare the two devices in terms of the incidence of postoperative vocal cord palsy in robot-assisted esophagectomy.
Therefore, the researchers aimed to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.
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)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 or older
- •American Society of Anesthesiologists physical status I - III
- •Elective robot-assisted esophagectomy
- •Any clinical stage of esophageal cancer
- •Patients who need recurrent laryngeal nerve lymph nodes resection
排除标准
- •Patients who diagnosed vocal cord palsy or damage before surgery
- •Patients who need specific airway device due to airway problem
- •History of thoracic surgery
- •Emergency surgery
- •Combined surgery with other department
- •Pregnant or nursing women
研究组 & 干预措施
double-lumen endobronchial tube group
干预措施: double-lumen endobronchial tube (Device)
bronchial blocker group
干预措施: bronchial blocker (Device)
结局指标
主要结局
Postoperative vocal cord palsy
时间窗: On postoperative day 7 after robot-assisted esophagectomy
On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy.
次要结局
- Number of resected recurrent laryngeal nerve lymph nodes(At the end of surgery)
- Surgical difficulty reported by surgeon(At the end of surgery)
- Quality of one lung ventilation(during one lung ventilation)
研究者
Hyun Joo Ahn
Professor, Anesthesiologist
Samsung Medical Center