Development and Application of a New Balloon Catheter for Intraairway Hemostasis
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2021
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedSeptember 26, 2022
September 1, 2022
1.1 years
December 19, 2021
September 21, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (15)
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
From date of randomization until the date of second operation , assessed 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
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
- +10 more secondary outcomes
Study Arms (2)
New balloon catheter for Endotracheal hemostasis + Traditional Therapy
EXPERIMENTAL1. Haemoptysis clinic for regular haemoptysis after treatment and life safety safeguard measures; 2. Balloon closure after informed consent (it can be blocked in emergency); 3. CTA (can be performed as an emergency prior to balloon blockage); 4. Artery interventional therapy (if necessary); 5. Surgery (if needed).
Traditional Therapy
ACTIVE COMPARATOR1. Haemoptysis clinic for regular haemoptysis after treatment and life safety safeguard measures; 2. CTA (can be performed as an emergency prior to balloon blockage); 3. Artery interventional therapy (if necessary); 4. Surgery (if needed).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2021
First Posted
September 26, 2022
Study Start
October 1, 2022
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
September 26, 2022
Record last verified: 2022-09