Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the MetaNeb® System can effectively prevent and treat early postoperative atelectasis in adult patients admitted to ICU after esophagectomy for esophageal cancer.
The main question it aims to answer is: can the MetaNeb® system significantly reduce the lung ultrasound score (LUSS) indicating atelectasis on postoperative days 1 and 2? Participants will be randomly assigned to either the standard treatment or MetaNeb group, undergo lung ultrasound and electrical impedance tomography (EIT) assessments on postoperative days 1 and 2, receive at least 4 sessions of MetaNeb therapy on postoperative day 1 if in the intervention group, be monitored for oxygenation indices, ICU stay duration, incidence of mechanical ventilation, need for bronchoscopic intervention, and adverse events like pneumothorax.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years.
- •Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.
排除标准
- •Presence of an artificial airway at the time of ICU admission.
- •Planned ICU stay less than 24 hours.
- •Patients with contraindications to the use of the MetaNeb® System, or those unable to cooperate due to organic or psychiatric conditions.
结局指标
主要结局
The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2
时间窗: From postoperative day 1 to day 2
次要结局
- The difference of dorsal ventilation region assessed by electrical impedance tomography (EIT) on postoperative day 1 and 2(From postoperative day 1 to day 2)
- The difference of PaO2/FiO2 ratios on postoperative day 1 and 2(From postoperative day 1 to day 2)
- The number of cases that underwent bronchoscopy intervention during ICU stay(From admission to ICU discharge)
- The number of cases that underwent high flow oxygen therapy or mechanical ventilation(From admission to ICU discharge)
- Length of ICU stay(From admission to ICU discharge)
- The number of cases that develop pneumothorax during intervention(From admission to the end of intervention at postoperative day 2)