Development and Application of a New Balloon Catheter for Intraairway Hemostasis

Not Applicable

Recruiting

• Conditions: Hemoptysis
• Interventions: Device: a New Balloon Catheter for Intraairway Hemostasis; Device: Traditional Therapy

• Registration Number: NCT05554731
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Study First Submitted: 2021-12-19
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Study Start: 2022-10-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New balloon catheter for Endotracheal hemostasis + Traditional Therapy	a New Balloon Catheter for Intraairway Hemostasis	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).
Traditional Therapy	a New Balloon Catheter for Intraairway Hemostasis	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).
Traditional Therapy	Traditional Therapy	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).
New balloon catheter for Endotracheal hemostasis + Traditional Therapy	Traditional Therapy	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).

Primary Outcome Measures

Name	Time	Method
Success rate of hemostasis 1 day after operation	1 day after operation	Success rate of hemostasis 1 day after operation
Intraoperative complication	During surgery	Significant increase in hemoptysis requiring other emergency management or suspension of operations, asphyxia, death, new arrhythmias, persistent worsening hypoxemia.
Immediate intraoperative success rate	Immediately after surgery	Immediate intraoperative success rate

Secondary Outcome Measures

Name	Time	Method
Incomplete completion rate of balloon closure operation	up to 13 months	compared with traditional balloon dilation group
Success rate of hemostasis 3 days and 1 and 2 weeks after operation	3 days and 1 and 2 weeks after operation	Success rate of hemostasis 3 days and 1 and 2 weeks after operation
Measurement indexes of follow-up treatment measures	From date of randomization until the date of second operation , assessed up to 13 months	Including CTA and its preparation time, rate of arterial embolization surgery and proportion of emergency surgery.
Anesthesia complications	During surgery	Complications after anesthesia including hypotension and shock, postoperative new tracheal intubation, coma and cerebrovascular accident.
success rate of placement	From date of randomization until death , assessed up to 13 months	success rate of placement
time and incidence of balloon leakage	From date of randomization until the date of second operation , assessed up to 13 months	time and incidence of balloon leakage (under the premise of two inflations per day)
Other complications	From date of randomization until the date of second operation , assessed up to 13 months	venous thrombosis of lower limbs
Rate of hemoptysis after balloon occlusion	up to 13 months	compared with traditional balloon dilation group
Rate of re-balloon closure	up to 13 months	compared with traditional balloon dilation group
hyoxemia	From date of randomization until the date of second operation , assessed up to 13 months	For more than 2 hours, oxygen saturation drops below 90%.
Balloon closure operation time	up to 13 months	Compared with the traditional dilated balloon group, the operation time of balloon closure was calculated
The operation rate of balloon occlusion again	From date of randomization until the date of second operation , assessed up to 13 months	The operation rate of balloon occlusion again
The bleeding time	From date of randomization until the date of second operation , assessed up to 13 months	The bleeding time
incidence of balloon displacement	From date of randomization until the date of second operation , assessed up to 13 months	incidence of balloon displacement (including the discount and distortion in the airway)
Nasal and bronchial mucosa injury	up to 13 months	Compared with the traditional dilated balloon group, the damage of nasal and bronchial mucosa after balloon closure was observed

Trial Locations

Locations (1)

The first affiliated hospital of wenzhou medical university; 🇨🇳 Wenzhou, Zhejiang, China