An interventional study of a New Balloon Catheter for Intraairway Hemostasis and Traditional Therapy in Hemoptysis, sponsored by First Affiliated Hospital of Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-26.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 20 interventional studies indexed under Hemoptysis.
Browse Hemoptysis studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 83 studies on the registry; 57 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: a New Balloon Catheter for Intraairway Hemostasis · Device: 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).
Device: a New Balloon Catheter for Intraairway Hemostasis · Device: Traditional Therapy
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.
Immediate intraoperative success rate
Immediate intraoperative success rate
Time frame: Immediately after surgery
Success rate of hemostasis 1 day after operation
Success rate of hemostasis 1 day after operation
Time frame: 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.
Time frame: During surgery
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
Time frame: 3 days and 1 and 2 weeks after operation
The bleeding time
The bleeding time
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: During surgery
hyoxemia
For more than 2 hours, oxygen saturation drops below 90%.
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
Other complications
venous thrombosis of lower limbs
Time frame: 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
Time frame: up to 13 months
success rate of placement
success rate of placement
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: up to 13 months
Rate of hemoptysis after balloon occlusion
compared with traditional balloon dilation group
Time frame: up to 13 months
Rate of re-balloon closure
compared with traditional balloon dilation group
Time frame: up to 13 months
Incomplete completion rate of balloon closure operation
compared with traditional balloon dilation group
Time frame: up to 13 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2022; primary completion for Oct 2023, 12 months later.
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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Wenzhou Medical University