Measure Airway Compliance by Endobronchial Optical Coherence Tomography
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|ClinicalTrials.gov Identifier: NCT05692362|
Recruitment Status : Enrolling by invitation
First Posted : January 20, 2023
Last Update Posted : January 20, 2023
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|Condition or disease|
|Tomography, Optical Coherence Bronchoscopy Respiratory Disease Airway Remodeling|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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.
- 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.
- 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
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|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|
- 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.
- 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;
- 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;
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05692362
|Guangzhou, Guangdong, China|
|Responsible Party:||Xu Hang, Dierctor of Intervetional Pulmonary Center, The First Affiliated Hospital of Guangzhou Medical University|
|Other Study ID Numbers:||
|First Posted:||January 20, 2023 Key Record Dates|
|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|
Respiratory Tract Diseases
Pathological Conditions, Anatomical