Development and Application of a New Balloon Catheter for Intraairway Hemostasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Success rate of hemostasis 1 day after operation
研究概览
简要总结
Massive hemoptysis is a serious disease of respiratory system, which seriously endangers the life of patients.
There are obvious difficulties in the treatment of hemoptysis. In the traditional treatment, patients still have the risk of massive hemoptysis and suffocation, and the risk control in the treatment process cannot be ensured.
Intra - airway interventional therapy, especially the hemostatic technique of intra - airway balloon catheter, is an important means to control the risk of hemoptysis.
However, the current intraairway balloon catheter therapy technology is immature, complicated and difficult to operate, and the cost is high. There is a lack of special balloon for hemostasis, and the balloon borrowed for other purposes cannot meet the needs of hemoptysis treatment.
Therefore, it is urgent to develop a new balloon catheter for airway hemostasis, which has simple technical operation, easy to master and popularize, efficient and safe function and structure.
According to this requirement, this project designed and developed hemostatic balloon catheter with multiple functions such as self-guiding, anti-displacement, anti-leakage and detachable rear end, so as to make the treatment of massive hemoptysis more safe and effective, simpler and faster, so as to be widely applied in clinical practice.
详细描述
This study are aimed to investigate the safety and effectiveness of the new intraairway hemostatic balloon catheter in the treatment of massive hemoptysis, as well as the superior efficacy compared with the traditional treatment strategy of massive hemoptysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were 18-75 years, male or non-pregnant female;
- •Meet the clinical definition of massive hemoptysis (blood loss ≥100ml each time or ≥500ml 24h);
- •The patient/legal authorized representative understood the purpose and procedure of the test and voluntarily signed the informed consent.
排除标准
- •Patients and their family members have no subjective treatment intention;Patients fail to cooperate or sign preoperative informed consent;
- •The obvious effect of balloon catheter therapy is not ideal;
- •Severe arrhythmia, acute myocardial ischemia;
- •blood pressure is not effectively controlled (diastolic blood pressure ≥95mmHg or systolic blood pressure ≥150mmHg);
- •Severe coagulopathy;
- •Severe organ insufficiency (except respiratory insufficiency);
- •Allergic to narcotic drugs;
- •Pregnant women, those who are breast-feeding or trying to conceive;
- •Patients who do not wish to sign informed consent;
- •Patients who failed to follow up;
- •Other patients deemed unsuitable for the study by the investigator.
结局指标
主要结局
Success rate of hemostasis 1 day after operation
时间窗: 1 day after operation
Success rate of hemostasis 1 day after operation
Intraoperative complication
时间窗: During surgery
Significant increase in hemoptysis requiring other emergency management or suspension of operations, asphyxia, death, new arrhythmias, persistent worsening hypoxemia.
Immediate intraoperative success rate
时间窗: Immediately after surgery
Immediate intraoperative success rate
次要结局
- Incomplete completion rate of balloon closure operation(up to 13 months)
- Success rate of hemostasis 3 days and 1 and 2 weeks after operation(3 days and 1 and 2 weeks after operation)
- Measurement indexes of follow-up treatment measures(From date of randomization until the date of second operation , assessed up to 13 months)
- Anesthesia complications(During surgery)
- success rate of placement(From date of randomization until death , assessed up to 13 months)
- time and incidence of balloon leakage(From date of randomization until the date of second operation , assessed up to 13 months)
- Other complications(From date of randomization until the date of second operation , assessed up to 13 months)
- Rate of hemoptysis after balloon occlusion(up to 13 months)
- Rate of re-balloon closure(up to 13 months)
- hyoxemia(From date of randomization until the date of second operation , assessed up to 13 months)
- Balloon closure operation time(up to 13 months)
- The operation rate of balloon occlusion again(From date of randomization until the date of second operation , assessed up to 13 months)
- The bleeding time(From date of randomization until the date of second operation , assessed up to 13 months)
- incidence of balloon displacement(From date of randomization until the date of second operation , assessed up to 13 months)
- Nasal and bronchial mucosa injury(up to 13 months)