Pulmonary emphysema
Conditions
Interventions
treatment group:Endobronchial valve + optimal medical treatment
control group:optimal medical treatment
According to the Global Strategy for the Diagnosis, Treatment, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) edition 2023, based on the patients condition and the doctor's judgment, t
=2 moderate acute exacerbations or =1 acute exacerbations leading to hospitalization in group E LABA+LAMA* If EOS=300, LABA+LAMA+ICS* was considered.
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients = 40 years of age =75 years of age, gender is not limited; (2) Patients clinically diagnosed with chronic obstructive pulmonary disease (COPD); (3) Heterogeneous emphysema was determined by HRCT examination, which was defined as: emphysema involved the target lung lobe =40%, and the difference from ipsilateral lobe =15%; (4) HRCT examination confirmed the integrity of target lobar interlobar fissure (cross section, coronal plane, sagittal plane) At least one face interlobar cleft integrity =90%); (5) Patients who meet the following measurement conditions: a. After inhaling bronchodilator, the measured value of forced expiratory volume (FEV1) in the first second is =15% The estimated value and =45% of the estimated value; b. Total lung volume (TLC) measured by plethysmography =100% of the predicted value; c. The measured residual gas (RV) value measured by plethysmography =150% of the expected value; (6) Patients with stable COPD (=6 weeks); (7) Patients with improved dyspnea index mMRC score =2 points; (8) Patients with 6-minute walking test (6MWT) =100m and =450m; (9) Patients who voluntarily participated in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with PaO2 45mmHg on echocardiography), etc.) Of patients; (6) Patients with heart failure (left ventricular ejection fraction 15mg of prednisone (or equivalent) per day; (10) Patients with giant bulla (bulla volume > 30% of ipsilateral pleural volume); (11) Patients with a history of major lung operations (such as surgical lung volume reduction, lobectomy, etc.); (12) Patients with moderate to high risk pulmonary nodules who are expected to require intervention within 6 months; (13) Patients who are allergic to nickel-titanium or silicone; (14) Pregnant or lactating women; (15) Patients who are participating in clinical trials of other drugs or medical devices; (16) The investigator believes that the patient has any other conditions that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume in one second (FEV1) difference from baseline 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Forced expiratory volume in 1 second (FEV1) difference from baseline at 3 and 12 months after surgery;Difference in forced vital capacity (FVC) from baseline at 3, 6, and 12 months after surgery;Residual air volume (RV) difference from baseline at 3, 6, and 12 months after surgery;Difference in total lung volume (TLC) from baseline at 3, 6, and 12 months after surgery;Changes from baseline in the 6-minute walking test (6MWT) at 3, 6, and 12 months after surgery;Changes in the modified dyspnea Index (mMRC) from baseline at 3, 6, and 12 months after surgery;Changes in the St. George's Respiratory Questionnaire (SGRQ) from baseline at 3, 6, and 12 months after surgery;The change of lung volume from baseline at 6 months after the operation; | — |
Countries
China
Contacts
Public ContactZhen Yang
Chinese PLA General Hospita
Outcome results
None listed