PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG): Phase II Randomized Feasibility Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prolonged Air Leak
研究概览
简要总结
Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after 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
- 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
- •Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer
- •Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system
排除标准
- 未提供
研究组 & 干预措施
D50
A solution of 50% glucose will be injected into the pleural space on the first and possibly the second day after surgery. The injection will be administered through the chest tube, which is already in place.
干预措施: Dextrose 50 (Drug)
Standard of care
monitor air leak, if the air leak continues on post-operative day #5, a talc pleurodesis may be given.
干预措施: Standard of Care - No Dextrose 50 (Other)
结局指标
主要结局
Prolonged Air Leak
时间窗: 5 days postoperatively
Prolonged Air Leak
次要结局
- Home with Chest Tube(immediately after the surgery)
- Duration of Chest Tubes(immediately after the surgery)
研究者
Mehdi Qiabi
Thoracic Surgeon, Assistant Professor, Western university
Lawson Health Research Institute