Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
The goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function. Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.
Interventions
PROCEDURELung volume reduction surgery with endobronchial valve implantation
the patient would undergo Lung volume reduction surgery with endobronchial valve implantation
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Chronic Obstructive Pulmonary Disease * FEV1 ≤ 45% pred and FEV1/FVC\<70% * TLC\>100% pred and RV\>175% pred * CAT score≥18 * Emphysema damage\>50% * Complete interlobar fissure \>95% based on quantitative analysis of CT measurement * No smoking\>6 months * Sign the informed consent form
Exclusion criteria
* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa * 6-minute walk test\<160m * Obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases * More than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment * Previous lobectomy, LVRS or lung transplantation * LVEF\<45% and or RVSP\>50mmHg * Anticoagulant therapy that cannot be stopped before surgery * Patients with obvious immune deficiency * Participated in other lung drug studies within the first 30 days of this study * Pulmonary nodules requiring intervention * Any disease or condition that interferes with the completion of the initial or subsequent assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline ventricular volume | Baseline | cardiac magnetic resonance imaging |
| Ventricular volume （6 months after surgery） | 6 months after surgery | cardiac magnetic resonance imaging |
| Ventricular volume（12 months after surgery） | 12 months after surgery | cardiac magnetic resonance imaging |
| Baseline FEV1 | Baseline | Pulmonary function tests |
| FEV1 （6 months after surgery） | 6 months after surgery | Pulmonary function tests |
| FEV1（12 months after surgery） | 12 months after surgery | Pulmonary function tests |
| Baseline left Ventricular Ejection Fractions | Baseline | Echocardiography |
| Left Ventricular Ejection Fractions （6 months after surgery） | 6 months after surgery | Echocardiography |
| Left Ventricular Ejection Fractions （12 months after surgery） | 12 months after surgery | Echocardiography |
| Baseline exercise tolerance | Baseline | 6-minute walk test |
| Exercise tolerance （6 months after surgery） | 6 months after surgery | 6-minute walk test |
| Exercise tolerance （12 months after surgery） | 12 months after surgery | 6-minute walk test |
| Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients | Baseline | St. George's Respiratory Questionnaire |
| Health impairment and quality of life of patients （6 months after surgery） | 6 months after surgery | St. George's Respiratory Questionnaire |
| Health impairment and quality of life of patients （12 months after surgery） | 12 months after surgery | St. George's Respiratory Questionnaire |
| Baseline cross sectional area of rectus femoris | Baseline | Rectus femoris ultrasound |
| Cross sectional area of rectus femoris （6 months after surgery） | 6 months after surgery | Rectus femoris ultrasound |
| Cross sectional area of rectus femoris （12 months after surgery） | 12 months after surgery | Rectus femoris ultrasound |
| Baseline mmuscle strength of lower limb | Baseline | Myometer |
| Mmuscle strength of lower limb （6 months after surgery） | 6 months after surgery | Myometer |
| Mmuscle strength of lower limb （12 months after surgery） | 12 months after surgery | Myometer |
Countries
China
Outcome results
None listed