Measure Airway Compliance by Endobronchial Optical Coherence Tomography

• ClinicalTrials.gov Identifier: NCT05692362
• Recruitment Status: Enrolling by invitation
• First Posted: January 20, 2023
• Last Update Posted: January 20, 2023
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Information provided by (Responsible Party): Xu Hang, The First Affiliated Hospital of Guangzhou Medical University

Study Description

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.

Condition or disease
Tomography, Optical Coherence; Bronchoscopy; Respiratory Disease; Airway Remodeling

Study Design

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Measure Airway Compliance by Endobronchial Optical Coherence Tomography
• Estimated Study Start Date: March 1, 2023
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Airway Compliance of different airway generation [ Time Frame: 2023/01/01-2024/12/31 ]

   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.

Secondary Outcome Measures :

1. Airway Compliance of different people [ Time Frame: 2023/01/01-2024/12/31 ]

   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.

Biospecimen Retention:   Samples With DNA

Airway Biopsy for IHC

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

China, Guangdong

Hang Xu

Guangzhou, Guangdong, China

Sponsors and Collaborators

The First Affiliated Hospital of Guangzhou Medical University

More Information

• Responsible Party: Xu Hang, Dierctor of Intervetional Pulmonary Center, The First Affiliated Hospital of Guangzhou Medical University
• ClinicalTrials.gov Identifier: NCT05692362
• Other Study ID Numbers: GYFYY20221108
• First Posted: January 20, 2023
• Last Update Posted: January 20, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Xu Hang, The First Affiliated Hospital of Guangzhou Medical University:

EB-OCT; Airway Compliance; Airway Remodeling

Additional relevant MeSH terms:

Respiration Disorders; Respiratory Tract Diseases; Airway Remodeling; Pathological Conditions, Anatomical