Development and Application of a New Balloon Catheter for Intraairway Hemostasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development and Application of a New Balloon Catheter for Intraairway Hemostasis

Conditions
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Hemoptysis

Intervention / Treatment
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* Device: a New Balloon Catheter for Intraairway Hemostasis
* Device: Traditional Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New balloon catheter for Endotracheal hemostasis + Traditional Therapy<br>Haemoptysis clinic for regular haemoptysis after treatment and life safety safeguard measures; Balloon closure after informed consent (it can be blocked in emergency); CTA (can be performed as an emergency prior to balloon blockage); Artery interventional therapy (if necessary); Surgery (if needed). | Device: a New Balloon Catheter for Intraairway Hemostasis<br>* 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.<br>Device: Traditional Therapy<br>* 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.<br>|
| Active Comparator: Traditional Therapy<br>Haemoptysis clinic for regular haemoptysis after treatment and life safety safeguard measures; CTA (can be performed as an emergency prior to balloon blockage); Artery interventional therapy (if necessary); Surgery (if needed). | Device: a New Balloon Catheter for Intraairway Hemostasis<br>* 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.<br>Device: Traditional Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |