Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
试验速览
- 阶段
- 不适用
- 入组人数
- 382
- 试验地点
- 5
- 主要终点
- Duration of chest drainage
研究概览
简要总结
This study is designed to compare the electronic chest drainage system (Drentech Palm Evo) with the traditional system, both already in use in the clinical practice, in a cohort of patients who received thoracoscopic lobectomy. This study is not evaluating safety or efficacy of these systems.
This study's primary aim is to determine if the use of a digital chest system compared with a traditional system reduce the duration of chest drainage and length of hospital stay. Moreover, the investigators aim to quantify the variability of results regarding the subjective observer evaluation of active air leaks (through the traditional system) compared with the objective data registered by the digital system.
Finally the investigators want to evaluate whether it is possible through the digital device to distinguish an active air leak from a pleural space effect by the evaluation of intrapleural differential pressure and to identify potential predictors of prolonged air leaks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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
- •Patients undergoing thoracoscopic lobectomy
- •Age 18 - 80 years
- •Gender: both
- •Estimated life expectancy of at least 6 months.
- •Tumour considered potentially resectable by R0 surgery
- •Adequate respiratory function for surgery.
- •Must have signed and dated an informed consent form (ICF), before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol.
排除标准
- •Patients requiring ICU care with mechanical ventilation
- •Patients needing reintervention during postoperative care
- •Patients requiring a thoracotomy
- •Tumour considered potentially resectable by incomplete surgical resection with microscopic residual disease (R1) or gross residual disease (R2).
- •Evidence of extra-thoracic disease.
- •Major thoracic surgical procedure before enrolment.
- •Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.
研究组 & 干预措施
Electronic chest drainage system
Patients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter.
干预措施: Electronic chest drainage system (Device)
Traditional device
Patients in the no intervention (traditional) arm are connected to traditional drain system with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with traditional devices (requiring connection to wall suction) are managed by applying suction (-20 cmH2O) until the morning of POD 1 and are subsequently disconnected from suction thereafter.
结局指标
主要结局
Duration of chest drainage
时间窗: from date of surgery to date of chest tube removal, assessed up to 8 days
Evaluation of the degree of concordance between the subjective observer evaluation of active air leaks compared with the objective data registered by the digital system in the patients with electronic chest drainage system
时间窗: from date of surgery to date of chest tube removal, assessed up to 8 days
Post-operative hospital length of stay
时间窗: from date of surgery to date of hospital discharge, assessed up to 8 days
次要结局
- Identification of potential predictors of prolonged air leaks through the analysis of the data registered by the digital system(from date of surgery to date of chest tube removal, assessed up to 8 days)
- Evaluation of intrapleural differential pressure in case of active air leak and in case of pleural space effect(from date of surgery to date of chest tube removal, assessed up to 8 days)
研究者
PROF. GIUSEPPE MARULLI
MD, PhD
University Hospital Padova