Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Sponsor
The First Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05692362
Collaborator
(none)
30
1
22
1.4

Study Details

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 Intervention/Treatment Phase

    Study Design

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

    Arms and Interventions

    Arm Intervention/Treatment
    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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Site City State Country Postal Code
    1 Hang Xu Guangzhou Guangdong China

    Sponsors and Collaborators

    • The First Affiliated Hospital of Guangzhou Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jan 20, 2023
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Dierctor of Intervetional Pulmonary Center, The First Affiliated Hospital of Guangzhou Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2023