Development and Application of a New Balloon Catheter for Intraairway Hemostasis

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.

Study Overview

• Status: Recruiting
• Conditions: Hemoptysis
• Intervention / Treatment: Device: a New Balloon Catheter for Intraairway Hemostasis; Device: Traditional Therapy

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen ChengShui, doctor; Phone Number: 8613806889081 86-13806889081; Email: wzchencs@163.com
• Study Contact Backup: Name: Li Yuping, doctor; Phone Number: 86-13587600968; Email: wzliyp@163.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: chengshui Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New balloon catheter for Endotracheal hemostasis + Traditional Therapy; 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; 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.; Device: Traditional Therapy; 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.
Active Comparator: Traditional Therapy; 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; 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.; Device: Traditional Therapy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: December 19, 2021
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Hemorrhage; Signs and Symptoms, Respiratory; Hemoptysis; Coagulants; Hemostatics
• Other Study ID Numbers: 2020C03067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No