The Effect of Regulated Pleural Pressure on The Duration of Air Leak and Fluid Drainage Following Pulmonary Anatomic Resections: A Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- duration of air leak
研究概览
简要总结
The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure.
In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to read, understand, and provide written Informed Consent;
- •Age range of 18-90 years;
- •Patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. Both open and minimally invasive (thoracoscopic) resections are acceptable.
排除标准
- •if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis
- •If during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis.
- •If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.
结局指标
主要结局
duration of air leak
时间窗: up to 7 days
次要结局
- 1. Differences in airflow detected during the 4 hours after the pressure level is switched to -8 cmH2O or -20 cmH2O compared to the original pressure level in both groups(up to 5 days)
- Differences in fluid drainage(up to 5 days)
- Duration of chest tube left in the patient (days)(up to 7 days)
- Postoperative length of hospital stay (days)(up to 7 days)
研究者
Cecilia Pompili
MD
Ospedali Riuniti Ancona