Chronic obstructive pulmonary disease characterized by chronic bronchitis
Conditions
Interventions
Test group:Pulse electric field ablation surgery for treatment
Control group:Fake surgery group, implementing simulated treatment
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range is 35-80 years old (including 35 and 80 years old), with no gender restrictions. 2. Suffering from chronic bronchitis, defined as coughing and sputum production for at least 3 months each year for two consecutive years, excluding other known causes. 3. The CAT questionnaire scores >= 10 points, and the total answer to the first two questions is >= 7 points; Or if the total answer to the first two questions of the CAT questionnaire is 6 points but the total score is greater than 20 points. 4. SGRQ score >= 25 points. 5. Diagnosed with COPD, FEV1 accounts for >= 30% of the expected value after using inhaled bronchodilators, FEV1/FVC= 10 packs per year), no smoking (cigarettes, electronic cigarettes, etc.) in the 3 months before the screening period, and agrees to quit smoking during the study period. 8. Able to understand the purpose of the experiment, agreed to participate in this study, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known unresolved lower respiratory tract infections (such as pneumonia, Mycobacterium avium infection (MAI), fungi, tuberculosis). 2. Suffering from steroid dependent diseases, requiring daily oral administration of>10mg corticosteroids. 3. There are any implanted electronic devices in the body (such as pacemakers, defibrillators). 4. History of ventricular tachycardia or clinically significant atrial tachycardia within the past two years, unless the arrhythmia has been treated and/or the subject has a normal heart rhythm during the screening phase. 5. Suffering from untreated lung cancer. 6. Suffering from pulmonary nodules or pulmonary cavities, and the researcher assessed that intervention may be necessary during the study period. 7. Previous lung surgeries, such as lung transplantation, lung volume reduction surgery (LVRS), lobectomy, lung implants/prostheses, metal airway stents, valves, coils, or bullectomy. Previous sub lobectomy, history of pneumothorax without lung resection, and history of pleural disease without surgical intervention are not excluded as criteria. According to baseline HRCT scan data analysis, the range of emphysema (CT value8%), uncontrollable hypertension (diastolic pressure>100mmHg), autoimmune diseases requiring immunosuppressive drugs or diseases requiring chemotherapy), and the researchers believe that diseases may endanger the life safety of patients or confuse the treatment response to patients. 12. There are uncontrolled symptoms of gastroesophageal reflux. 13. According to clinical evaluation, there is a risk of pulmonary arterial hypertension (defined as pulmonary artery systolic pressure>50mmHg on echocardiography). The walking distance in 14.6 minutes is less than 225 meters. 15. It is known that there are contraindications for bronchoscopy or general anesthesia, or allergies to related drugs (lidocaine, atropine, benzodiazepines) that cannot be relieved by medication. 16. Pregnant, lactating, and women preparing to conceive. 17. Currently participating in clinical research on other drugs or devices (with intervention measures). 18. Other situations assessed by researchers as unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COPD Assessment Test (CAT); | — |
Secondary
| Measure | Time frame |
|---|---|
| COPD Assessment Test (CAT);Improved respiratory distress index mMRC score;COPD version of St. George's Respiratory Questionnaire (SGRQ);6-minute walking distance (6MWT);Pulmonary function testing;Distal Airway Volume,DAV; Total Airway Counts,TAC; lung volume;Acute exacerbation; | — |
Countries
China
Contacts
Public ContactJiayuan Sun
Shanghai Chest Hospital
Outcome results
None listed