Research of Endobronchial Optical Coherence Tomography in Pre-COPD
- Conditions
- Optical Coherence TomographyPulmonary FunctionChronic Obstructive Pulmonary Disease
- Interventions
- Device: Optical Coherence Tomography
- Registration Number
- NCT06436482
- Lead Sponsor
- Sichuan Provincial People's Hospital
- Brief Summary
The pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) is challenging to diagnose. However, identifying Pre-COPD is a crucial step in the prevention and management of COPD. Endobronchial optical coherence tomography showed the value of diagnosis in Pre-COPD and COPD in previous researchs.
- Detailed Description
We recruited COPD patients (stage I-II, n=15; stage III-IV, n= 15), Pre-COPD (n= 20) and healthy never-smokers (healthy human, n=21). Age,gender,BMI, smoking history, spirometry, chest computed tomography (CT), bronchoscopy and EB-OCT were performed. Inner luminal area (Ai) and airway wall area (Aw) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively. By analyzing and studying the above situation, we aim to discover the application value of OCT in Pre-COPD
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).
- (1) patients with contraindication of bronchoscopy, (2) patients who are participating in other clinical studies, (3) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (4) women who were pregnant.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Optical Coherence Tomography non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT). Chronic Obstructive Pulmonary Disease (COPD) Optical Coherence Tomography COPD was diagnosed based on GOLD guideline \[1\]; No acute exacerbations within 4 weeks; CT scans show no other pulmonary diseases besides COPD; pulmonary function test results were available from within the last 3 days. All COPD patients were treatment-naive except for those with at stage III-IV who received maintenance therapy Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) Optical Coherence Tomography Patients exhibit early pulmonary abnormalities, such as, CT scans show the presence of emphysema, bullae, and air trapping; pulmonary function manifested as preserved ratio impaired spirometry (PRISm). PRISm was defined as a normal ratio \[the forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ≥ 0.7\] after inhalation of a bronchodilator, but impaired ventilatory function \[percentage of forced expiratory volume in the first second to the expected value (FEV1%) and/or percentage of FVC to the expected value (FVC%) \< 80%\], with concurrent structural changes in the lungs (such as emphysema) and/or physiological abnormalities (such as hyperinflation, decreased diffusion capacity, rapid decline in FEV1 )
- Primary Outcome Measures
Name Time Method EB-OCT parameters in different stages of COPD baseline Inner luminal area (Ai，mm) and airway wall area (Aw,mm2) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively.
Representative EB-OCT images of airway disorders baseline Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD
- Secondary Outcome Measures
Name Time Method FEV1/FVC ratio baseline Baseline clinical characteristics baseline Age（year）, gender(Male/female), smoking history(yes/no)
pulmonary function test (FEV1 predicted %) baseline Baseline clinical characteristics
MMEF 25/75 baseline Baseline clinical characteristics
BMI（Kg/m2)） baseline
Trial Locations
- Locations (1)
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China