Measure Airway Compliance by Endobronchial Optical Coherence Tomography

NCT05692362 | Unknown

• 1 other identifier: GYFYY20221108
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

EB-OCT; Airway Compliance; Airway Remodeling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Airway Compliance of different people

  2023/01/01-2024/12/31

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Regardless of gender, age 18-70 years old;
• Patients with clinical diagnosis of pulmonary nodules, COPD, asthma or restrictive pulmonary diseases;
• Can tolerate bronchoscopy patients;
• Sign the informed consent form.

You may not qualify if:

• Suffering from any of the following respiratory diseases: bronchiectasis, etc;
• Have malignant tumors that are not completely remission or cured;
• The patient's systemic infection is not controlled;
• Recent use of immunosuppressants, recent use of anticoagulants (such as warfarin or aspirin within 2 weeks of drugs that affect blood clotting function);
• Serious other systemic diseases: myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc.;
• Those who are positive for syphilis, HIV, HBV, and HCV antibodies;
• Patients with coagulation dysfunction diseases, such as hemophilia, giant platelet syndrome, platelet weakness, etc.;
• Severe renal impairment, serum creatinine \> 1.5 times the upper limit of normal value;
• Liver disease or liver function impairment: ALT, AST, total bilirubin \> 2 times the upper limit of normal value;
• Those with a history of mental illness or suicide, a history of epilepsy or other central nervous system diseases;
• 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;
• Those who are allergic to catheters and related materials required for experiments;
• Subjects who have received any other clinical studies within 3 months prior to enrollment;
• Those who have poor compliance and difficulty in completing the study;
• Any condition that the clinician believes may increase the risk to the patient or interfere with the clinical study.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Hang Xu

Guangzhou, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Airway Biopsy for IHC

MeSH Terms

Conditions

Respiration Disorders; Airway Remodeling

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dierctor of Intervetional Pulmonary Center

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 20, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)