Post-lobectomy Use of Glucose for Pleurodesis and Air-leak Cessation. A Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Air leak cessation
研究概览
简要总结
It is common practice to leave a chest drainage catheter after lung surgical resections to manage air leaks. The air leakage will usually stop in the initial postoperative days, but in a few patients, it will last for a longer period of time, preventing the removal of the chest tube that can lead to patient discomfort, increased likelihood to develop postoperative complications and longer length of hospital stay. Pleurodesis is an effective method to address postoperative air leak which consists in injecting an irritating solution into the chest cavity. This is not performed regularly after lung resections for different reasons including associated pain, costs, and fear of infections. Pleurodesis with hyperosmolar glucose solution have been used for years with good results in some Asian countries because of its simplicity and low cost. Its effectiveness for pleurodesis has been reported in cases of spontaneous pneumothorax and chylothorax, but its efficiency to stop air leaks in the postoperative period remains to be defined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients aged 18 years or older at the time of surgery
- •Having undergone a simple lung lobectomy for malignancy, primary or metastatic
- •Procedure performed through thoracotomy, sternotomy or video-assisted thoracic surgery (VATS), and associated or not to mediastinoscopy, staging thoracoscopy, mediastinal lymph nodes sampling or mediastinal lymph nodes dissection
- •Normally recovery after a surgery performed between 12 and 24 hours earlier
排除标准
- •High amount of liquid drainage from chest tube (>500 cc in the last 8 hours)
- •Minimal air leak (<20 cc/min in one of the last 4 hours)
- •Large air leak (>500 cc/min in one of the last 4 hours)
- •History of previous ipsilateral thoracotomy, lung resection, rib fracture, chest trauma, or lung/thoracic infection
- •Diabetes or hyperglycemia
- •Immunity disorders
- •Allergy to local anaesthetics
- •Hemodynamic instability
- •Need for respiratory support
- •Inability to give informed consent
研究组 & 干预措施
Hypertonic 50% dextrose pleurodesis
干预措施: Hypertonic 50% dextrose pleurodesis (Drug)
结局指标
主要结局
Air leak cessation
时间窗: 48 hours after time of initial injection of 50% glucose solution
air leak \<20 cc/min for 4 hours or more
次要结局
- Time to chest tube removal(30-day post-operative period)
- Time to air leak cessation(30-day post-operative period)
- Length of hospitalization(30-day post-operative period)
- Postoperative complications(30-day post-operative period)
研究者
Eric Frechette
Principal Investigator
Lawson Health Research Institute