Clinical trial NCT05554731: Development and Application of a New Balloon Catheter for Intraairway Hemostasis
Official title: Development and Application of a New Balloon Catheter for Intraairway Hemostasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemoptysis
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate intraoperative success rate
timeFrame: Immediately after surgery
measure: Success rate of hemostasis 1 day after operation
timeFrame: 1 day after operation
measure: Intraoperative complication
timeFrame: During surgery
Secondary outcomes:
measure: Success rate of hemostasis 3 days and 1 and 2 weeks after operation
timeFrame: 3 days and 1 and 2 weeks after operation
measure: The bleeding time
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: The operation rate of balloon occlusion again
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: Measurement indexes of follow-up treatment measures
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: Anesthesia complications
timeFrame: During surgery
measure: hyoxemia
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: Other complications
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: Balloon closure operation time
timeFrame: up to 13 months
measure: success rate of placement
timeFrame: From date of randomization until death , assessed up to 13 months
measure: time and incidence of balloon leakage
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: incidence of balloon displacement
timeFrame: From date of randomization until the date of second operation , assessed up to 13 months
measure: Nasal and bronchial mucosa injury
timeFrame: up to 13 months
measure: Rate of hemoptysis after balloon occlusion
timeFrame: up to 13 months
measure: Rate of re-balloon closure
timeFrame: up to 13 months
measure: Incomplete completion rate of balloon closure operation
timeFrame: up to 13 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The first affiliated hospital of wenzhou medical university
state: Zhejiang
Study officials:
References: