Measure Airway Compliance by Endobronchial Optical Coherence Tomography

NCT ID: NCT05692362

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy People

People with solitary pulmonary nodule， without any other pulmonary diseases.

No interventions assigned to this group

Chronic Airway Diease People

People with COPD or Asthma

No interventions assigned to this group

Pulmonary fibrosis people

People were diagnosised pulmonary fibrosis by chest Computer Tomography, and restrictive ventilatory impairment by pulmonary function test.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xu Hang

Dierctor of Intervetional Pulmonary Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hang Xu

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GYFYY20221108

Identifier Type: -

Identifier Source: org_study_id