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Application of EIT Pulmonary Function Testing Equipment in Early Screening of COPD

Application of pulmonary function testing equipment based on electrical impedance tomography technology in early screening of chronic obstructive pulmonary disease

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098482
Enrollment
Unknown
Registered
2025-03-10
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD )

Interventions

Pre-COPD group:NA
Healthy control group:NA

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, willing to participate in the trial, and signed informed consent. 2.Healthy control group: At least 20 non-smokers (no smoking in the past 12 months and smoking history = 0.7, FEV1 >= 80% and FVC >= 80% of predicted values, and no small airway dysfunction (SAD, defined as MMEF%, FEF50% and FEF75%, when at least two of these three indicators are below 65% of predicted values)) healthy participants. No significant cardiovascular, pulmonary, gastrointestinal, hepatic, endocrine, renal, hematological, neurological or mental diseases were determined based on medical history, physical examination and clinical biochemical tests. 3. Pre-chronic Obstructive Pulmonary Disease group: At least 20 participants with pre-chronic obstructive pulmonary disease who have normal lung function (defined as FEV1/FVC >= 0.7 after inhalation of bronchodilators) but have symptoms (defined as chronic cough and/or chronic expectoration and/or dyspnea) and any of the following risk factors: (1) corresponding CT abnormalities, such as bullae, emphysema, air trapping or thickening of the bronchial wall shown on CT; (2) evidence of accelerated decline in FEV1 (>= 60 mL/year); (3) FEV1 and/or FVC < 80% predicted value after inhalation of bronchodilators; (4) existing SAD as defined above. 4. COPD group: Patients diagnosed with COPD by clinical doctors. According to the definition and risk factors, those with FEV1/FVC < 0.7 after inhalation of bronchodilators and excluding other diseases are included. The severity of airflow obstruction is classified according to GOLD 2024, and at least 20 patients are included in each group.

Exclusion criteria

Exclusion criteria: 1. Any diseases other than COPD related airway diseases that affect the results of lung function tests, such as asthma, active tuberculosis, interstitial lung disease, bronchiectasis, history of chest surgery/radiotherapy, ventilatory insufficiency syndrome related to obesity, laryngeal cancer, etc. 2. Patients who are unable to undergo EIT assessment or whose EIT results are interfered with, such as those with implanted pacemakers/defibrillators, pregnant women (the current is within the safe range and theoretically has no impact on the fetus, but there is a lack of clinical research evidence), or obese patients with BMI > 35, and those with local skin infections or open wounds on the chest area of the skin where the electrode strap is attached, as well as subjects with neuromuscular diseases such as myasthenia gravis and nemaline myopathy. 3. Patients who have contraindications to pulmonary function tests, are unable to perform pulmonary function tests, or do not meet the 2019 American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria for the acceptability of pulmonary function tests. 4. Allergic to salbutamol aerosol. 5. Unstable diseases, including but not limited to autoimmune diseases, serious thyroid disease, serious heart disease (including severe cardiovascular diseases such as severe hypertension, atrial fibrillation, hypertrophic cardiomyopathy), serious kidney disease, malignant tumors, etc.

Design outcomes

Primary

MeasureTime frame
FEV1/FVC;

Secondary

MeasureTime frame
FEV1/FVC abnormal area;global inhomogeneity (GI);coefficients of variation (CV);mMRC;CAT;

Countries

China

Contacts

Public ContactYahong Chen

Peking University Third Hospital

chenyahong@vip.sina.com+86 13910232918

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026