Research of Endobronchial Optical Coherence Tomography in Pre-COPD (EBOCTIPCOPD)

Sichuan Provincial People's Hospital

Status: Enrolling

Conditions: Pulmonary Function; Optical Coherence Tomography; Chronic Obstructive Pulmonary Disease

Treatments: Device: Optical Coherence Tomography

Study type: Observational

Funder types: Other

Identifiers

NCT06436482

SichuanPPHGZ02

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).

Exclusion criteria

• (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.

Trial design

80 participants in 3 patient groups

Control group

Description:

non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).

Treatment:

Device: Optical Coherence Tomography

Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD)

Description:

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 )

Treatment:

Device: Optical Coherence Tomography

Chronic Obstructive Pulmonary Disease (COPD)

Description:

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

Treatment:

Device: Optical Coherence Tomography