Study to Evaluate a Low Suction (LS) Versus Standard Suction (SS) Strategy for Patients Undergoing Minimally Invasive Lung Resection by VATS or Robotic Approach
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Duration of air-leak
研究概览
简要总结
Chest tubes are routinely required after surgical procedures for lung cancer. This device is a flexible plastic tube that is inserted through the chest wall to remove air or fluid from around your lungs after surgery for lung cancer. There are two general strategies associated with the clinical management of chest tubes, active and passive suction. If suction is compared to driving a car, active suction is similar to pressing the gas pedal while passive suction is like letting your car move on its own. The suction approach taken by surgeons largely depends on how they were trained and some personal biases and beliefs. However there is no general consensus about which chest tube management strategy is best.
This research aims to compare two settings on a digital drainage system, a low suction (LS) mode - passive suction - and standard suction (ss) mode - active suction. From the data collected, the researchers will analyze whether LS or SS will lead to a better recovery after surgery.
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
- •Patients who are undergoing lobectomy or segmentectomy
- •Patients undergoing wedge resection to diagnose, or as definitive therapy for a lung nodule/cancer.
- •Able to understand and sign consent
排除标准
- •Patients undergoing pneumonectomy or bilobectomy
- •Patients undergoing resection for inflammatory conditions such as aspergillosis
- •Patients undergoing diagnostic wedge resection for interstitial lung disease
- •Patients undergoing redo-VATS or thoracotomy on the same side as current planned resection
- •Patients found to have a "frozen chest" at the time of surgery, requiring extensive adhesiolysis,
- •Patients who are discovered to have metastatic disease during the operation, so that resection is no longer indicated.
- •Patients where a clinical decision to place more than one chest-tube is made
研究组 & 干预措施
Low Suction Strategy of Chest Tube Management
干预措施: Low Suction Strategy of Chest Tube Management (Other)
Standard Suction Strategy of Chest Tube Management
干预措施: Standard Suction Strategy of Chest Tube Management (Other)
结局指标
主要结局
Duration of air-leak
时间窗: When the subject arrives to the recovery room directly after surgery, then every 24 hours while admitted to the hospital until air leak resolves (on average, up to 4 days)
Days
次要结局
- Incidence of prolonged air-leak(Categorial variable: Present or not. Determination of category is measured from onset of air-leak to air-leak resolution or 5 days, whichever comes first.)
- Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable(duration of study participation, which is until the chest-tube is removed, duration of initial hospital stay, or 30 days from operation, whichever is longer)
- Duration of hospital stay(Date of surgery to date of discharge (up to 5 days on average))
- Impact of suction strategy on patients with high Prolonged Air-Leak Score(duration of study participation which is until chest tube is removed, duration of hospital stay, or 30 days from operation, whichever is longer)
- Days from operation to chest tube removal(chest tube placement to chest tube removal on average up to 4 days)
研究者
Hiran Fernando, MD
Chief of Thoracic Surgery at Allegheny General Hospital
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)