Improvement and Clinical Application of a New Minimally Invasive Closed Thoracic Drainage System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Total drainage time
研究概览
简要总结
According to the problems of traditional closed thoracic drainage in clinical work, this study aims to further improve and improve the new closed thoracic drainage system by changing the material of drainage tube, increasing the regulating valve of external fixator and increasing the gas flow monitoring kit for special patients, so as to expand its clinical application scope and formulate its operation. Standardize. At the same time, through a randomized controlled study, the simplicity, effectiveness and safety of the new minimally invasive thoracic closed drainage system developed by the research group were deeply studied.
详细描述
The traditional closed thoracic drainage method has complex operation and high technical requirements. It has obvious pain during and after operation. Operational complications such as tissue organs, intercostal vessels and nerve injury may occur during the operation. Accidents may also occur after catheterization, including leakage around thoracic drainage tube, thoracic drainage tube prolapse, subcutaneous emphysema and accumulation. Liquid; To solve these problems, we have invented "minimally invasive thoracic closed drainage system" through a number of patent designs, including: thoracic closed drainage tube implantation expansion forceps, double-chamber thoracic drainage device with side balloon, guide wire, puncture needle, various types of dilators, chest tube fixation devices, etc. The system has the characteristics of minimally invasive puncture and implantation of drainage tube, safe, fast operation, no need of suture and fixation, good position of drainage tube after implantation, less pain for patients, and closing incision in the medial part of patients, avoiding leakage and subcutaneous emphysema and hydrops.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The selection criteria were as follows:
- •age 18-70 years, gender is not limited;
- •subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study and sign the informed consent;
- •18 Kg/m2 < BMI < 25 Kg/m2;
- •patients who need thoracic closed drainage for exhaust and drainage because of pneumothorax volume > 30%;
- •subjects did not have serious chest wall deformities.
排除标准
- •Patients at high risk of bleeding, including patients with congenital hemophilia, thrombocytopenia (PLT < 50 *109/L), platelet dysfunction (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction);
- •Cardiopulmonary function is poor, which is not suitable for the participants.
- •Patients with other infectious diseases (inflammation, tuberculosis) or empyema in the thoracic cavity;
- •Infection of skin around puncture and drainage;
- •Participated in other clinical trials within 30 days;
- •Other reasons why the researchers think it is inappropriate to participate in the experiment.
结局指标
主要结局
Total drainage time
时间窗: up to 24 weeks
Efficiency of treatment
Pulmonary reexpansion ratio
时间窗: up to 24 weeks
Pulmonary reexpansion ratio
次要结局
- VAS pain score during and after operation(up to 24 weeks)
研究者
Yongxin Zhou
Director
Shanghai Tongji Hospital, Tongji University School of Medicine