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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New balloon catheter for Endotracheal hemostasis + Traditional Therapy | Experimental |
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| Traditional Therapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a New Balloon Catheter for Intraairway Hemostasis | Device | In the treatment group, the new balloon catheter was inserted in three steps, that is, the tracheoscope was inserted into the airway to remove the blood in the airway and find the target bronchus.The new airway hemostatic balloon catheter was directly inserted through the tracheoscopy biopsy channel, and then directly inflated and fixed after positioning.Then exit the tracheoscope directly to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate intraoperative success rate | Immediate intraoperative success rate | Immediately after surgery |
| Success rate of hemostasis 1 day after operation | Success rate of hemostasis 1 day after operation | 1 day after operation |
| Intraoperative complication | Significant increase in hemoptysis requiring other emergency management or suspension of operations, asphyxia, death, new arrhythmias, persistent worsening hypoxemia. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of hemostasis 3 days and 1 and 2 weeks after operation | Success rate of hemostasis 3 days and 1 and 2 weeks after operation | 3 days and 1 and 2 weeks after operation |
| The bleeding time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen ChengShui, doctor | Contact | 86-13806889081 | 8613806889081 | wzchencs@163.com |
| Li Yuping, doctor | Contact | 86-13587600968 | wzliyp@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of wenzhou medical university | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D006469 | Hemoptysis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| Traditional Therapy | Device | A six-step technique was adopted to place the traditional balloon catheter, that is, the tracheoscope was entered to find the target bronchus, the guide wire was inserted through the biopsy channel, the tracheoscope was exchanged to exit the tracheoscope, the catheter was entered through the guide wire exchange, the tracheoscope was re-entered, the catheter was positioned, inflated and fixed, and the tracheoscope was withdrawn. |
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The bleeding time
| From date of randomization until the date of second operation , assessed up to 13 months |
| The operation rate of balloon occlusion again | The operation rate of balloon occlusion again | From date of randomization until the date of second operation , assessed up to 13 months |
| Measurement indexes of follow-up treatment measures | Including CTA and its preparation time, rate of arterial embolization surgery and proportion of emergency surgery. | From date of randomization until the date of second operation , assessed up to 13 months |
| Anesthesia complications | Complications after anesthesia including hypotension and shock, postoperative new tracheal intubation, coma and cerebrovascular accident. | During surgery |
| hyoxemia | For more than 2 hours, oxygen saturation drops below 90%. | From date of randomization until the date of second operation , assessed up to 13 months |
| Other complications | venous thrombosis of lower limbs | From date of randomization until the date of second operation , assessed up to 13 months |
| Balloon closure operation time | Compared with the traditional dilated balloon group, the operation time of balloon closure was calculated | up to 13 months |
| success rate of placement | success rate of placement | From date of randomization until death , assessed up to 13 months |
| time and incidence of balloon leakage | time and incidence of balloon leakage (under the premise of two inflations per day) | From date of randomization until the date of second operation , assessed up to 13 months |
| incidence of balloon displacement | incidence of balloon displacement (including the discount and distortion in the airway) | From date of randomization until the date of second operation , assessed up to 13 months |
| Nasal and bronchial mucosa injury | Compared with the traditional dilated balloon group, the damage of nasal and bronchial mucosa after balloon closure was observed | up to 13 months |
| Rate of hemoptysis after balloon occlusion | compared with traditional balloon dilation group | up to 13 months |
| Rate of re-balloon closure | compared with traditional balloon dilation group | up to 13 months |
| Incomplete completion rate of balloon closure operation | compared with traditional balloon dilation group | up to 13 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |