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Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05692362
Enrollment
30
Registered
2023-01-20
Start date
2023-03-01
Completion date
2024-12-31
Last updated
2023-01-20

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

Conditions

Airway Remodeling, Bronchoscopy, Respiratory Disease, Tomography, Optical Coherence

Keywords

EB-OCT, Airway Compliance, Airway Remodeling

Brief summary

Optical Coherence Tomography (OCT)is a novel, non-invasive, high resolution special optical imaging techniques. In airway, Measure airway area and airway wall thickness is the most usage of Endobronchial Optical Coherence Tomography (EB-OCT). Recently, the new protocol of EB-OCT is used to measure airway compliance, We will establish a new methodology of EB-OCT for measuring airway compliance, which will provide a new means to study respiratory diseases.

Interventions

None listed

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. Regardless of gender, age 18-70 years old; 2. Patients with clinical diagnosis of pulmonary nodules, COPD, asthma or restrictive pulmonary diseases; 3. Can tolerate bronchoscopy patients; 4. Sign the informed consent form.

Exclusion criteria

1. Suffering from any of the following respiratory diseases: bronchiectasis, etc; 2. Have malignant tumors that are not completely remission or cured; 3. The patient's systemic infection is not controlled; 4. Recent use of immunosuppressants, recent use of anticoagulants (such as warfarin or aspirin within 2 weeks of drugs that affect blood clotting function); 5. Serious other systemic diseases: myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc.; 6. Those who are positive for syphilis, HIV, HBV, and HCV antibodies; 7. Patients with coagulation dysfunction diseases, such as hemophilia, giant platelet syndrome, platelet weakness, etc.; 8. Severe renal impairment, serum creatinine \> 1.5 times the upper limit of normal value; 9. Liver disease or liver function impairment: ALT, AST, total bilirubin \> 2 times the upper limit of normal value; 10. Those with a history of mental illness or suicide, a history of epilepsy or other central nervous system diseases; 11. 12-lead ECG showing severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or conduction abnormalities of the heart of grade II and above; 12. Those who are allergic to catheters and related materials required for experiments; 13. Subjects who have received any other clinical studies within 3 months prior to enrollment; 14. Those who have poor compliance and difficulty in completing the study; 15. Any condition that the clinician believes may increase the risk to the patient or interfere with the clinical study.

Design outcomes

Primary

MeasureTime frameDescription
Airway Compliance of different airway generation2023/01/01-2024/12/31Airway compliance is the property of the airway lumen area to change as pressure changes. This is caused by airway structure, the small airway without cartilage compared with medium and large airways, so the compliance would be different. But the methods of measuring airway compliance is difficult, In this research, we will use OCT to measure airway area (mm2), and record the airway pressure(cmH2O), The ratio of area change to pressure change is the compliance, we will measure and compare the compliance of different airway generation.

Secondary

MeasureTime frameDescription
Airway Compliance of different people2023/01/01-2024/12/31Airway compliance is the property of the airway lumen area to change as pressure changes. This is caused by airway structure, the airway of COPD, asthma or pulmonary fibrosis compared to healthy people are different, so the compliance would be different. But the methods of measuring airway compliance is difficult, In this research, we will use OCT to measure airway area (mm2), and record the airway pressure(cmH2O), The ratio of area change to pressure change is the compliance, we will measure and compare the compliance of different people.

Countries

China

Outcome results

None listed

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