Development and Application of a New Balloon Catheter for Intraairway Hemostasis

Wenzhou Medical University

Status: Enrolling

Conditions: Hemoptysis

Treatments: Device: a New Balloon Catheter for Intraairway Hemostasis; Device: Traditional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05554731

2020C03067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

New balloon catheter for Endotracheal hemostasis + Traditional Therapy

Experimental group

Description:

1. 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).

Treatment:

Device: Traditional Therapy

Device: a New Balloon Catheter for Intraairway Hemostasis

Traditional Therapy

Active Comparator group

Description:

1. 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).

Treatment:

Device: Traditional Therapy

Device: a New Balloon Catheter for Intraairway Hemostasis