Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Guangzhou Medical University

Status: Invitation-only

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

Study type: Observational

Funder types: Other

Identifiers

NCT05692362

GYFYY20221108

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 3 patient groups

Healthy People

Description:

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

Chronic Airway Diease People

Description:

People with COPD or Asthma

Pulmonary fibrosis people

Description:

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