Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Respiratory Disease Clinical Trial

Official title:

Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05692362
• Other study ID #: GYFYY20221108
• Status: Enrolling by invitation
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Remodeling
• Bronchoscopy
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Tomography, Optical Coherence

Locations

Country	Name	City	State
China	Hang Xu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway Compliance of different airway generation	Airway 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.	2023/01/01-2024/12/31
Secondary	Airway Compliance of different people	Airway 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.	2023/01/01-2024/12/31