Measure Airway Compliance by Endobronchial Optical Coherence Tomography

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Respiratory Disease; Bronchoscopy; Airway Remodeling; Tomography, Optical Coherence

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Hang Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy People and People with COPD or asthma 、 restrictive pulmonary diseases.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy People; People with solitary pulmonary nodule， without any other pulmonary diseases.
Chronic Airway Diease People; People with COPD or Asthma
Pulmonary fibrosis people; People were diagnosised pulmonary fibrosis by chest Computer Tomography, and restrictive ventilatory impairment by pulmonary function test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: EB-OCT; Airway Compliance; Airway Remodeling
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiration Disorders; Respiratory Tract Diseases; Airway Remodeling
• Other Study ID Numbers: GYFYY20221108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes