Suction on Post-Operative Chest Tubes After Video-Assisted Thoracoscopic Surgery Lobectomy for Presumed or Confirmed Primary Lung Cancer - At Which Level?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Chest tube duration through study completion, an average of 3 days.
研究概览
简要总结
The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These results, however, are based on traditional drainage systems with water seal and need to be confirmed using digital drainage systems.
Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10 cmH2O when looking at chest tube duration and complications.
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
- Single (Care Provider)
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
- •Speaks and understands Danish.
- •Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.
排除标准
- •Cannot cooperate or unable to give consent.
- •Chronic drain carrier.
- •Planned open procedure.
- •Planned resection of additional wedge, additional lobe or thoracic wall.
研究组 & 干预措施
Group 1
Post-operative suction is set to -2 cmH2O.
干预措施: Suction is set to -2 cmH2O (Device)
Group 2
Post-operative suction is set to -10 cmH2O (standard treatment).
干预措施: Suction is set to -10 cmH2O (Device)
结局指标
主要结局
Chest tube duration through study completion, an average of 3 days.
时间窗: Through study completion, an average of 3 days.
Time from intraoperative chest tube placement to it's removal.
次要结局
- Number of participants with pneumonia or empyema.(Through study completion, an average of 21 days)
- Number of participants with prolonged air leak(Through study completion, an average of 7 days)
- Number of participants requiring treatment for prolonged air leak.(Through study completion, an average of 14 days)
- Number of participants with other respiratory problems.(Through study completion, an average of 30 days)
- Time to removal criteria have been fulfilled up to 24 hours(Duration from the post-operative chest tube has been placed, until it's potential removal.)
- Length of stay.(Through study completion, an average of 3 days)
- Number of participants requiring treatment for subcutaneous emphysema.(Through study completion, an average of 14 days)
- Number of participants requiring readmission for thoracic surgical complications.(Through study completion, an average of 30 days)
研究者
Bo Laksáfoss Holbek
Medical doctor
Rigshospitalet, Denmark