Second Affiliated Hospital of Zhejiang University,School of Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- the incidence of postoperative pulmonary complications
研究概览
简要总结
Respiratory failure and dyspnea are common in spinal cord injury (SCI), and in acute situations, any spinal cord lesion above T11 can cause abnormal respiratory function and impair the airway clearance.
Although surgical decompression is one of the key early neuroprotective therapies, surgery and general anesthesia disrupt many aspects of respiratory function and may cause a series of postoperative pulmonary complications.
Endotracheal suction is important to reduce the risk of lung consolidation and atelectasis. But for patients with respiratory insufficiency such as SCI, ordinary suction is not enough to clear secretions in the deeper airways. And repeated intratracheal suction may even cause some serious complications.
Bronchoscopy can generally penetrate into the bronchus of grade 3-4, and fully attract the secretions in it under visual conditions. Its curative effect on pneumonia and atelectasis in the ICU has been affirmed, but no one has yet explored the application in the postoperative care unit .
详细描述
All patients admitted to PACU with tracheal tube after operation will be recruited, and than be randomly divided into two groups during resuscitation:
- one group receives routine ordinary sputum suction ; the other group receives routine ordinary sputum suction with bronchoscopy
- After entering the PACU, both groups will receive two lung ultrasound examinations and record the lung ultrasound scores: when entering PACU and when leaving PACU.
After returning to the ward, the doctor in charge will make medical decisions and treatments based on the condition.
Follow up for pulmonary complications (respiratory tract infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, pulmonary edema, pulmonary embolism, aspiration pneumonia) within 7 days after surgery.
Follow-up 30 days and 90 days after operation.
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
- Double (Participant, Outcomes Assessor)
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 Spinal injury level :above T11 Stable preoperative spontaneous respiration Elective cervical/thoracic spine fixation American Spinal Injury Association (ASIA) class: A-D
排除标准
- •Unconscious before surgery Pregnant With mental disorders Directly transfered to ICU
结局指标
主要结局
the incidence of postoperative pulmonary complications
时间窗: within 7 days after operation or before discharge, whichever came first
postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis including respiratory infection, respiratory failure,pleural effusion, atelectasis, pneumothorax , broncospasm and aspiration pneumonitis
次要结局
未报告次要终点