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Research of Endobronchial Optical Coherence Tomography in Pre-COPD

Research of Endobronchial Optical Coherence Tomography in Pre-stage of Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06436482
Acronym
EBOCTIPCOPD
Enrollment
80
Registered
2024-05-31
Start date
2023-03-01
Completion date
2024-07-01
Last updated
2024-05-31

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

Conditions

Chronic Obstructive Pulmonary Disease, Optical Coherence Tomography, Pulmonary Function

Keywords

Chronic Obstructive Pulmonary Disease, Optical Coherence Tomography, pre-stage

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

Interventions

DEVICEOptical Coherence Tomography

Placing the probe of OCT in RB10c through the working channel of bronchoscope for real time dynamic scanning and collecting OCT parameters from participants in different groups.

Sponsors

Sichuan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Representative EB-OCT images of airway disordersbaselineRepresentative EB-OCT images(airway remodeling, mucosa thickening ) in CP,Pre-COPD and COPD
EB-OCT parameters in different stages of COPDbaselineInner 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.

Secondary

MeasureTime frameDescription
pulmonary function test (FEV1 predicted %)baselineBaseline clinical characteristics
Baseline clinical characteristicsbaselineAge(year), gender(Male/female), smoking history(yes/no)
MMEF 25/75baselineBaseline clinical characteristics
FEV1/FVC ratiobaseline
BMI(Kg/m2))baseline

Countries

China

Contacts

Primary ContactGuanghong G Zhou, Master
zhough0526@163.com86-18302880040
Backup ContactGuanghong G Zhou, Master
zhough0526@163.com18302880040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026