Patients with PRISm and chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
PRISm intervention group:Treatment with an external diaphragm pacemaker
Control group (healthy subjects):None
Stable COPD patient intervention group:Treatment with an external diaphragm pacemaker
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen University Hospital of Hepatology)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. To simultaneously explore the improvements in lung function, diaphragm morphology and function, and systemic inflammation in individuals with PRISm (preserved ratio impaired spirometry) after external diaphragm pacing (EDP) therapy, compared with patients with stable COPD; 2. Whether EDP can improve the impaired lung function in the PRISm population; 3. To explore the interrelationship between the preserved ratio impaired spirometry (PRISm) status and the development of chronic obstructive pulmonary disease (COPD) before and after treatment with external diaphragm pacing (EDP).
Exclusion criteria
Exclusion criteria: 1. Evidence of pulmonary infection or severe infection in other sites on chest CT within the past 3 months; 2. Presence of other serious lung diseases, such as interstitial pneumonia; 3. Presence of neuromuscular diseases, such as diaphragmatic paralysis, myasthenia gravis, etc.; 4. Presence of major organ dysfunction or failure, such as respiratory failure, heart failure, myocardial infarction, cerebral infarction, etc.; 5. Presence of severe chronic wasting diseases, such as malignant tumors; 6. Long-term use (more than one month) of medications that may affect diaphragmatic function or structure (e.g., neuromuscular blocking agents, glucocorticoids, sedative-hypnotics, etc.); 7. Contraindications to external diaphragm pacemaker use: pneumothorax, active pulmonary tuberculosis, or patients with an implanted cardiac pacemaker; 8. Patients with neurological or cognitive impairments, or other reasons that preclude cooperation with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function;Diaphragm ultrasound; | — |
Secondary
| Measure | Time frame |
|---|---|
| Collect baseline data;Routine blood test;Modified Medical Research Council Dyspnea Scale (mMRC score)andCOPD Assessment Test (CAT score);Inflammatory markers; | — |
Countries
China
Contacts
Public ContactQu Jielan
The Third Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen University Hospital of Hepatology)
Outcome results
None listed